Pfizer’s TALZENNA Plus XTANDI FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment Setting




Pfizer’s TALZENNA Plus XTANDI FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment Setting

TALZENNA plus XTANDI is now approved for HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, offering a potential new standard of care earlier in the course of disease

Approval based on pivotal Phase 3 TALAPRO-3 data, which showed an estimated 52% reduction in the risk of radiographic progression or death

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has expanded approval of TALZENNA^® (talazoparib) in combination with XTANDI^® (enzalutamide) to the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (PC) with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations. mAPMN/S is also known as metastatic hormone-sensitive prostate cancer (mHSPC). This approval makes TALZENNA, an oral poly ADP-ribose polymerase (PARP inhibitor), plus XTANDI, an androgen receptor pathway inhibitor (ARPI), available in an earlier line, providing an opportunity to delay disease progression at a critical stage when more patients may experience greater benefit.

“Today’s approval of TALZENNA plus XTANDI builds on its established role as a standard-of-care option for men with advanced prostate cancer. Moving this targeted therapy into the androgen pathway modulation-naïve or -sensitive setting further reflects our commitment to men with HRR-mutated metastatic prostate cancer, providing a new option at a stage where it may have a greater impact to delay progression.”

– Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer

“This approval represents a critical advancement for patients with newly diagnosed metastatic prostate cancer with HRR gene mutations, who face a more aggressive disease, worse prognosis, and limited treatment options. In the TALAPRO-3 trial, clinical benefits were consistent for patients with BRCA and non-BRCA HRR gene mutations, addressing a long-standing unmet need – and reinforcing the importance of biomarker testing at the time of diagnosis.”

– Neeraj Agarwal, M.D., FASCO, Co-director of Prostate Cancer Program at Harvard Cancer Consortium, faculty medical oncologist at Dana-Farber Cancer Institute, and global lead investigator for TALAPRO-3

TALZENNA plus XTANDI was first approved in the U.S. in 2023 for men with metastatic androgen pathway modulation resistant (mAPMR) PC with HRR gene mutations, also known as HRRm metastatic castration-resistant prostate cancer (mCRPC). The application to expand the indication was reviewed under FDA Priority Review and was supported by results from the Phase 3 TALAPRO-3 study.

Key Results from the Pivotal Phase 3 TALAPRO-3 Study

• Improved Radiographic Progression-Free Survival (rPFS): TALZENNA plus XTANDI reduced the risk of radiographic progression or death by 52% vs. placebo plus XTANDI (Hazard Ratio [HR] of 0.48; 95% Confidence Interval [CI], 0.36–0.65; p ˂ 0.0001) in patients with mAPMN/S PC with HRR gene mutations and an estimated 77% of patients remained progression-free at three years. Consistent benefit was observed across patients with BRCA and non-BRCA HRR gene mutations.
• Consistent Safety Profile: The safety profile was consistent with the known profiles of each agent, and no new safety signals were identified. The most common treatment-emergent adverse events (TEAEs) in the TALZENNA plus XTANDI group were anemia, fatigue, decreased neutrophil count, and asthenia. The most common grade 3 or higher TEAE was anemia, reported by 51% in the TALZENNA plus XTANDI group and 3% in the control group. Five percent of patients discontinued TALZENNA due to anemia. TEAEs were generally manageable with dose modifications and supportive care as needed.
• Published Previously: These results were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.

About the TALAPRO-3 Phase 3 Study

• TALAPRO-3 (NCT04821622) is a multicenter, randomized, double-blind, placebo-controlled study that enrolled 599 patients with mAPMN/S PC with ≤3 months of androgen deprivation therapy (ADT) [chemical or surgical] with or without an approved ARPI in the mAPMN/S setting at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region.
• Patients were randomized to receive TALZENNA 0.5 mg/day plus XTANDI 160mg/day, or placebo plus XTANDI 160mg/day.
• The primary endpoint is investigator-assessed rPFS, defined as the time from the date of randomization to radiographic progression in soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or in bone per Prostate Cancer Working Group 3 (PCWG3) criteria by investigator assessment, or death, whichever occurs first.

About mAPMN/S PC (mHSPC)

• mAPMN/S PC is a form of advanced prostate cancer that has spread beyond the prostate but is still sensitive to androgen deprivation therapy.¹
• Approximately 25% of patients with mAPMN/S PC (mHSPC) harbor HRR gene mutations.²

Advancing Pfizer’s Leadership in Genitourinary Cancers

This milestone reflects Pfizer’s 20-year commitment to driving advances in genitourinary cancers, and its efforts to advance precision medicines into earlier stages of disease, where they may have even more impact for patients. TALZENNA plus XTANDI is an established standard of care for HRR gene-mutated mAPMR PC and this FDA approval brings the combination to men at an earlier stage of disease, when delaying disease progression may have an even greater impact. An application is also under review by the European Medicines Agency (EMA), with additional global regulatory filings planned or underway. The FDA conducted their review of TALZENNA plus XTANDI under Project Orbis, an Oncology Center of Excellence initiative that provides a framework for concurrent submission and review of oncology drugs among international partners.

Related Content

• https://www.pfizer.com/news/press-release/press-release-detail/talzenna-plus-xtandi-improves-radiographic-progression-free
• https://www.pfizer.com/news/press-release/press-release-detail/pfizers-talzennar-combination-xtandir-receives-us-fda
• https://www.nejm.org/doi/full/10.1056/NEJMoa2604126

About TALZENNA^® (talazoparib)

TALZENNA is an oral inhibitor of poly ADP-ribose polymerase (PARP), which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death.

TALZENNA was initially approved in the U.S., EU, and multiple other regions as a single agent for the treatment of adult patients with deleterious or suspected deleterious gBRCAm HER2-negative locally advanced or metastatic breast cancer.

TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated metastatic androgen pathway modulation resistant (mAPMR) PC in June 2023. The combination was also approved by the European Commission in January 2024 for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. TALZENNA in combination with XTANDI is approved in more than 60 countries; indications vary by country.

About XTANDI^® (enzalutamide)

XTANDI (enzalutamide) is an androgen receptor pathway inhibitor. XTANDI is a standard of care and has received regulatory approvals around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), mCRPC, non-metastatic castration-resistant prostate cancer (nmCRPC), and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 80 countries, including in the United States, European Union, and Japan. Over 1.5 million patients have been treated with XTANDI globally.³

XTANDI^® is jointly developed and commercialized by Pfizer and Astellas in the United States.

TALZENNA^® (talazoparib) Indications in the U.S.

TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:

Breast Cancer:

As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2‑negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA‑authorized companion diagnostic for TALZENNA.

Prostate Cancer:

In combination with enzalutamide for the treatment of adult patients with:

• metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer with homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test.
• metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with HRR gene mutations, as detected by an FDA-authorized test.

IMPORTANT SAFETY INFORMATION 

WARNINGS AND PRECAUTIONS 

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. In clinical studies, among 1,096 patients treated with TALZENNA as a single agent or as part of a combination regimen with enzalutamide, the cumulative incidence of MDS/AML was approximately 1% including 0.6% with fatal outcomes. The incidence of MDS/AML among patients treated with active control or with placebo in combination with enzalutamide was 0.2%. The median duration of therapy with TALZENNA in patients who developed MDS/AML was approximately 2.8 years (range: 1 to 5.8 years).  

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA. 

Myelosuppression consisting of anemia, leukopenia/neutropenia, and/or thrombocytopenia has been reported in patients treated with TALZENNA. Grade ≥ 3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 49%, 19%, and 9% of patients receiving TALZENNA in combination with enzalutamide. Forty-one percent of patients required a red blood cell transfusion, including 25%  who required more than one transfusion. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 7%, 4%, and 1% of patients. 

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. 

Embryo-Fetal Toxicity TALZENNA can cause fetal harm when administered to a pregnant woman. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 4 months following the last dose of TALZENNA. 

ADVERSE REACTIONS 

In the pooled safety population of 810 patients with prostate cancer, the most common (≥ 20%) adverse reactions including laboratory abnormalities were decreased hemoglobin (86%), decreased neutrophils (68%), decreased lymphocytes (62%), decreased platelets (54%), fatigue (48%), decreased albumin (26%), decreased calcium (26%), back pain (24%), decreased appetite (22%), and nausea (21%). 

DRUG INTERACTIONS 

Coadministration With P-gp Inhibitors The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor. 

Coadministration With BCRP Inhibitors Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor. Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions. 

USE IN SPECIFIC POPULATIONS 

Males of Reproductive Potential Based on animal studies, TALZENNA may impair fertility.  

Renal Impairment Reduce the recommended dosage of TALZENNA in patients with moderate (CLcr 30 – 59 mL/min) and severe (CLcr 15 – 29 mL/min) renal impairment. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis. 

INDICATIONS 

TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with:

• Metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer with homologous recombination repair gene mutations (HRRm), as detected by an FDA-authorized test
• Metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair gene mutations (HRRm), as detected by an FDA-authorized test

Please see the Full Prescribing Information for TALZENNA. There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly.

XTANDI^® (enzalutamide) Indications in the U.S.

XTANDI (enzalutamide) is indicated for the treatment of patients with:

• castration-resistant prostate cancer (CRPC)
• metastatic castration-sensitive prostate cancer (mCSPC)
• nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)

XTANDI^® (enzalutamide) U.S. Important Safety Information

Warnings and Precautions

Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.

Interference with Immunoassay Measurement of Digoxin XTANDI can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving XTANDI and digoxin.

Adverse Reactions (ARs)

In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.

Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.

Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI. Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

Please access this link for XTANDI’s U.S. Full Prescribing Information for additional safety information.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at www.facebook.com/Pfizer/.

Disclosure Notice

The information contained in this release is as of October 26, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer Oncology, TALZENNA and XTANDI, including their potential benefits, the TALAPRO-3 results, an approval in the U.S. for TALZENNA in combination with XTANDI to expand the use of TALZENNA plus XTANDI to the treatment of men with HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer and additional global regulatory filings planned or underway, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of TALZENNA in combination with XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the TALAPRO-3 trial will meet the key secondary endpoint for overall survival; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for TALZENNA, XTANDI or a combination may be filed in particular jurisdictions for any potential indications; whether and when any such applications for TALZENNA, XTANDI or a combination that may be pending or filed may be approved by regulatory authorities (including the application under review by the EMA for TALZENNA in combination with XTANDI for men with HRR gene-mutated mAPMN/S PC), which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether TALZENNA, XTANDI or a combination will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of TALZENNA, XTANDI or a combination; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

Contacts

Media Contact:
PfizerMediaRelations@Pfizer.com

Investor Contact:
IR@Pfizer.com

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VeriSIM Life Powers the AI Behind Next-Generation Cell Preservation




VeriSIM Life Powers the AI Behind Next-Generation Cell Preservation

• Company brings mechanistic AI to ARPA-H’s up to $6.5 million initiative to transform cell therapy preservation and eliminate cold-chain dependence.

SAN FRANCISCO–(BUSINESS WIRE)–VeriSIM Life, a pioneer in mechanistic artificial intelligence for drug discovery and development, today announced its participation in an initiative funded by the Advanced Research Projects Agency for Health (ARPA-H) through its BioStabilization Systems (BoSS) program. The initiative aims to revolutionize how living cells are preserved, stored, and transported, addressing one of the most significant barriers to scaling advanced cell therapies.

Led by DesiCorp, the multidisciplinary consortium includes VeriSIM Life, Ossium Health, Via Therapeutics, the University of Louisville, and the University of Texas at Austin. Together, the team will combine expertise in computational biology, cellular engineering, formulation science, and advanced manufacturing to develop technologies that could eliminate the need for ultra-cold storage.

VeriSIM Life will contribute its mechanistic AI expertise to help accelerate the development of next-generation cell preservation technologies. By bringing predictive biological intelligence into the development process, VeriSIM aims to support more efficient innovation and reduce the experimental complexity of preserving living cells while maintaining their viability and function.

“AI’s greatest opportunity in life sciences is not simply discovering new medicines, but fundamentally transforming how we develop and deliver them,” said Dr. Jo Varshney, Founder and CEO of VeriSIM Life. “Through this ARPA-H initiative, we are extending the power of mechanistic AI to one of the most challenging frontiers in biotechnology: preserving living systems outside the human body. Success could reshape the economics, scalability, and global accessibility of cell-based therapies.”

“The ARPA-H BoSS program presents an exciting opportunity to fundamentally change how cell-based medicines are preserved and distributed,” said Dr. Brett Janis, co-founder and CEO of DesiCorp. “Addressing the scientific and engineering challenges associated with room-temperature preservation requires a multidisciplinary approach, and we are excited to collaborate with VeriSIM Life to combine AI-driven modeling with our team’s experimental capabilities. Together, we aim to accelerate the development of innovative preservation technologies that could ultimately make life-saving cell therapies more accessible to patients.”

The initiative represents a significant expansion of VeriSIM Life’s mechanistic AI capabilities beyond drug discovery and development into biostabilization and biomanufacturing, reinforcing the company’s broader vision of building predictive intelligence across the therapeutic lifecycle.

About VeriSIM Life

VeriSIM Life is pioneering mechanistic AI to transform drug discovery and development. Its proprietary BIOiSIM^® platform combines mechanistic biosimulation with machine learning to predict biological outcomes, reduce translational risk, and accelerate therapeutic development. Through collaborations with pharmaceutical companies, research institutions, and government agencies, VeriSIM Life is building a more predictive and efficient future for life sciences.

Contacts

Media Contact
Emily Spady

marketing@verisimlife.com

Meta Cell Technology Brings Together International Medical Educators for First MCT Academy – Train the Trainers




Meta Cell Technology Brings Together International Medical Educators for First MCT Academy – Train the Trainers

Physicians and scientific experts from MCT’s international network met in Crete for advanced medical education, scientific exchange and the formal recognition of MCT Trainers.

BARCELONA, Spain–(BUSINESS WIRE)–Meta Cell Technology has held the first edition of MCT Academy – Train the Trainers in Hersonissos, Crete, from 2 to 4 October 2026, bringing together experienced physicians, scientific experts and medical educators from its international network.

Under the motto “Learning. Sharing. Leading.”, the programme combined scientific foundations, clinical protocols, evidence review, guest faculty sessions and multidisciplinary discussion. Designed for professionals actively involved in physician education, the initiative marks a further step in strengthening MCT’s educational and scientific network across more than 70 countries.

An Interdisciplinary Approach to Regenerative Medicine

The programme brought together professionals from orthopaedic surgery and traumatology, sports medicine, gynaecology, trichology, dermatology, aesthetic medicine and regenerative medicine. The international faculty included Dr. Edgar Michael T. Eufemio, Dr. Madiha Azmat Rao, Dr. Luciana Macedo and Cristina Domínguez, alongside sessions led by Dr. Hernán Pinto, Chief Scientific Officer and Co-founder of Meta Cell Technology.

The scientific agenda was developed under the supervision of the Scientific Committee, comprising Dr. Laura Cordero, Elena Sánchez Vizcaíno, Sara Cervantes and Adrià Reigosa, ensuring a focus on current evidence, clinical relevance and continuing medical education.

Dr. Hernán Pinto, Chief Scientific Officer and Co-founder of Meta Cell Technology

“Medical education should not be limited to teaching a protocol. Physicians need to understand the scientific rationale, examine the evidence critically and recognise the clinical context in which a technology may be relevant”

International Scientific Exchange and Trainer Certification

The meeting coincided in Crete with Suprema Experience Greece, organised by Suprema MED, MCT’s distribution partner in Brazil. The two programmes created further opportunities for scientific exchange and networking between the international MCT community and Brazilian physicians.

A key milestone was the formal recognition of physicians from different countries as MCT Trainers, who received their certificates at the closing session. The certification marks a new stage in developing MCT’s international trainer network, supporting peer-to-peer scientific education and knowledge exchange across markets.

Philippe Plan, Chief Executive Officer of Meta Cell Technology

“International growth needs to be accompanied by investment in knowledge. As MCT expands into new markets, our responsibility is not only to make the technology available, but also to ensure that physicians and our local partners have access to high-quality scientific education. MCT Academy is becoming an important part of how we approach that growth, by connecting people, knowledge and clinical experience across countries.”

Through MCT Academy, the company continues to develop in-person educational programmes, international webinars and evidence-led scientific content to support healthcare professionals.

ABOUT MCT ACADEMY

MCT Academy is Meta Cell Technology’s scientific and medical education platform, supporting evidence-led education and knowledge exchange around photothermal biomodulation in regenerative medicine.

ABOUT META CELL TECHNOLOGY

Meta Cell Technology is a Barcelona-based medical technology company focused on conditioning autologous biological material through photothermal biomodulation. It operates internationally through distribution partners and healthcare professionals, with a portfolio that includes CE-marked medical devices and an ISO 13485-certified quality management system.

Contacts

Sherry Cacay Llanes
Marketing Manager

globalmarketing@clinipro.net | metacelltech.com

Impulse London to Premiere Chemsex Documentary Chemtrail: The Journey at Rich Mix




Impulse London to Premiere Chemsex Documentary Chemtrail: The Journey at Rich Mix

LONDON–(BUSINESS WIRE)–#ChemsexAwareness—Impulse London invites the LGBTQ+ community and allies to screenings of Chemtrail: The Journey on 7^th and 8^th November at 2pm at Rich Mix. The documentary shares the realities of chemsex in London and the search for support and recovery through the lived experiences of Ben, Pank, Declan, and Matthew. Tickets available at Eventbrite.

Chemsex remains a central focus of Impulse London’s advocacy work. The organisation raises awareness, signposts people to support, and works to keep Londoners, especially queer men, safe. In 2024 and 2025, it staged Chemtrail and Chemtrail: This is Killing Us, to raise awareness and support harm reduction and recovery. This year’s event goes deeper, using lived experience and storytelling to challenge stigma and show that help is available.

Alex Tridico, president of Impulse London, said, “Over the past two years, our Chemtrail events have used art to continue conversations about chemsex in our community. This film takes that further. By listening to people’s stories in their own words, we can better understand the different routes people took to find support and recovery, and we hope to make it easier for others to take that first step.”

Chemtrail: The Journey was brought to life by LGBTQ+ directors and producers John Reavy and Jordi Estapé Montserrat. Working with Impulse London, the duo have created an emotional film that shares four stories with sensitivity and respect.

Each screening will be followed by a talk exploring themes raised in the documentary, with a focus on support, recovery, and the different experiences and pathways people may take. Tickets are £5 (or pay what you can), and free community tickets are available. All proceeds will go to Controlling Chemsex and London Friend.

Impulse London is a community-led advocacy organisation working with gay and queer men. Through advocacy, events, education and community engagement, Impulse works to create spaces for open conversations around mental health, substance use awareness, sexual health, and social justice. Impulse London is an affinity group of AIDS Healthcare Foundation.

AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS healthcare organization, provides cutting-edge medicine and advocacy to more than 3.3 million people across 50 countries, including the U.S. and in Africa, Latin America/Caribbean, the Asia/Pacific Region, and Eastern Europe. In January 2025, AHF received the MLK, Jr. Social Justice Award, The King Center’s highest recognition for an organization leading work in the social justice arena. To learn more about AHF, visit us online at AIDShealth.org, find us on Facebook, and follow us on Instagram, Twitter, and TikTok.

Contacts

MEDIA CONTACT:

Charlie Reynolds, Marketing Director, Impulse London Charlie.Reynolds@impulsegrp.org

Las Vegas Rallies for City of Hope’s First Walk for Hope in the City, Raising Funds for Lifesaving Cancer Research




Las Vegas Rallies for City of Hope’s First Walk for Hope in the City, Raising Funds for Lifesaving Cancer Research

Patients, survivors, caregivers and families joined entertainer Donny Osmond, the event’s “Headliner for Hope,” to honor loved ones and stand with people facing cancer

LAS VEGAS–(BUSINESS WIRE)–#cityofhope–City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, welcomed more than 1,700 patients, survivors, caregivers and supporters to its inaugural Walk for Hope Las Vegas on Saturday, Oct. 24. Together, walkers raised more than $220,000 and counting for lifesaving cancer research and care.

Entertainer and longtime City of Hope supporter Donny Osmond served as the event’s inaugural “Headliner for Hope,” helping introduce Walk for Hope to the Las Vegas community and rally participation in the lead-up to the event. He and his wife, Debbie, led Team Debbie & Donny Osmond, joining walkers at the Civic Center in downtown Las Vegas.

With a nearly 50-year history, Walk for Hope is City of Hope’s signature community fundraising campaign and event series, uniting patients, survivors, caregivers and supporters to honor loved ones, celebrate survivors and raise funds for lifesaving cancer research and compassionate care. In 2023, Walk for Hope expanded beyond Southern California to communities where City of Hope operates cancer centers, and now continues its growth with the inaugural Las Vegas event.

Philanthropy powers City of Hope’s work, from early-stage discovery to the clinical trials that bring new therapies to patients.

Lennar, one of the nation’s leading homebuilders, served as a local sponsor of the event, helping bring the walk to the Las Vegas community.

“Walk for Hope is hope in action, and the Las Vegas community has shown us what that truly means,” said Kristin Bertell, chief philanthropy officer at City of Hope. “City of Hope isn’t defined solely by where we have buildings, but by the people and communities who believe in our mission to end cancer for all. For years, Las Vegas donors, volunteers and corporate partners have helped advance that mission, and this inaugural walk is a powerful reflection of their continued commitment. We’re deeply grateful to Lennar and everyone who came together to make this special day possible.”

The walk brought together a community where access to specialized cancer care remains a challenge. Cancer is the second leading cause of death in Nevada, and the state has about half the number of oncologists relative to its population compared with the national average. City of Hope is committed to expanding access to the latest cancer breakthroughs, and its national network offers more than 700 active clinical trials.

“Every person facing cancer deserves access to the expertise, clinical trials, and innovative therapies that can improve outcomes and quality of life,” said Harlan Levine, M.D., president of health innovation and policy at City of Hope. “For patients and families in Nevada, where the need for specialized cancer care is known, creating that access can make a meaningful difference. Developing new drugs, helping them come to market faster and safely, and making them more accessible for patients closer to home are central to our mission to improve the cancer outcomes in the communities we serve.”

Throughout the day, teams of families, friends and coworkers walked in honor of parents, partners and loved ones. Survivors walked alongside them, cheered on by the people who stood by them through treatment.

“Las Vegas is a city of big dreams, and for families facing cancer, the biggest dream is more time with the people they love,” said Las Vegas Mayor Shelley Berkley. “Improving access to quality health care for Nevadans has been a priority throughout my career, and Las Vegas is proud to support Walk for Hope and the research that brings new hope to our community.”

For the Osmonds, the cause is personal. Cancer has touched their family, including the loss of Debbie’s mother.

“Las Vegas has given Debbie and me so much over the years, and walking alongside this community in support of City of Hope was a meaningful way to give back,” said Donny Osmond. “Cancer has touched so many families, including our own. Seeing neighbors come together to honor loved ones and celebrate survivors was a reminder that Las Vegas always shows up when people need it most.”

Among the day’s meaningful moments was a performance of the national anthem by Las Vegas-based entertainer Jennifer “JayBee” Beasley, a Hodgkin lymphoma survivor who received a stem cell transplant at City of Hope after multiple rounds of treatment and a clinical trial. Cancer-free since September 2014, JayBee joined fellow participants at Walk for Hope, lending her voice to a cause that has profoundly shaped her life.

Las Vegas joins a national series of Walk for Hope events that City of Hope hosts each fall in communities across the country, from Chicago and Atlanta to Arizona and Southern California. Each walk brings neighbors together to honor loved ones, celebrate survivors and advance research that benefits patients nationwide. This year’s season continues Nov. 7 in Arizona and Atlanta and concludes Nov. 8 in Los Angeles and Orange County, with virtual participation open to supporters anywhere.

To make a gift, register to participate or learn more, visit cityofhope.org/walkforhope.

About City of Hope

City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the United States, and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked among the nation’s top cancer centers by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, Orange County, California, campus, a network of clinical care locations across Southern California and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope^TM. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.

Contacts

City of Hope
Bridget Livengood
blivengood@coh.org

The Ferraro Group
Kenzie Papa
Kenzie@theferrarogroup.com
702-858-3108

KEYTRUDA® (pembrolizumab) as Monotherapy Reduced the Risk of Disease Progression or Death by 43% for Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient (dMMR) Tumors Compared to Chemotherapy




KEYTRUDA® (pembrolizumab) as Monotherapy Reduced the Risk of Disease Progression or Death by 43% for Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient (dMMR) Tumors Compared to Chemotherapy

KEYNOTE-C93 showed median progression-free survival (PFS) was more than four times longer for these patients treated with KEYTRUDA as monotherapy (38.2 months) compared to platinum doublet chemotherapy (8.4 months)

KEYNOTE-C93 is the first Phase 3 trial of a PD-1 inhibitor to show a statistically significant and clinically meaningful improvement in PFS as monotherapy compared to chemotherapy in these patients

Late-breaking results were selected for an official press briefing and will be presented during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) Congress 2026 and published simultaneously in The Lancet

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the Phase 3 KEYNOTE‑C93 trial, evaluating KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence after receiving prior adjuvant therapy. Results showed KEYTRUDA as monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) for these patients, reducing the risk of disease progression or death by 43% (HR=0.57; [95% CI, 0.42-0.79]; p=0.0002) compared to platinum doublet chemotherapy. These late-breaking results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 [Presentation #LBA12], were selected for an official ESMO press briefing and were published simultaneously in The Lancet.

After a median follow-up of 36.7 months (range, 28.4-50.0), median PFS was 38.2 months (95% CI, 17.9-NR) for KEYTRUDA versus 8.4 months (95% CI, 6.8-10.4) for chemotherapy, with 36-month PFS rates of 52.8% (95% CI, 44.2-60.7) versus 30.0% (95% CI, 22.4-37.9), respectively. In addition to an improvement in PFS, a favorable trend in overall survival (OS), the trial’s other primary endpoint, was observed for KEYTRUDA monotherapy versus platinum doublet chemotherapy (HR=0.77 [95% CI, 0.52-1.15]; p=0.1000). Median OS was not reached (NR) (95% CI, NR-NR) for KEYTRUDA versus NR (95% CI, 38.9-NR) for chemotherapy, with 36-month OS rates of 70.7% (95% CI, 62.4-77.5) versus 62.0% (95% CI, 53.1-69.8), respectively. The trial is continuing, and follow-up of OS is ongoing. Results will be shared with regulatory authorities worldwide.

“These results highlight the potential of a chemotherapy-free approach for certain patients with dMMR advanced or recurrent endometrial cancer, with pembrolizumab monotherapy demonstrating a clinically meaningful benefit in progression-free survival compared to chemotherapy,” said Dr. Brian Slomovitz, director of Gynecologic Oncology and deputy director of the Braman Comprehensive Cancer Center at Mount Sinai Medical Center in Miami Beach, Florida, and the study’s overall principal investigator. “After years of platinum-based chemotherapy serving as the frontline standard, these findings could help provide an additional treatment option beyond carboplatin plus paclitaxel in combination with KEYTRUDA for these patients.”

“KEYTRUDA is already part of an established treatment regimen with platinum doublet chemotherapy for patients with primary advanced or recurrent endometrial cancer regardless of mismatch repair status, and we’re excited by these results showing its further potential as a monotherapy option for appropriate patients whose tumors are dMMR,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “As incidence rates of endometrial cancer continue to rise, we remain committed to advancing new potential treatment options for women facing this disease.”

Confirmed objective response rate (ORR), a key secondary endpoint, was 64.1% (95% CI, 55.8-71.9) with KEYTRUDA versus 62.1% (95% CI, 53.6-70.0) with chemotherapy; complete response rates were 33.8% and 26.2%, respectively. ORR was not tested for statistical significance at this analysis. Among responders, median duration of response (DOR) was not reached for patients receiving KEYTRUDA versus 10.2 months for patients receiving chemotherapy; the 24-month DOR rate was 77.0% versus 41.3%, and the 36-month DOR rate was 70.7% versus 40.0%, respectively.

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies, and no new safety signals were identified in either treatment arm. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 18.1% of patients receiving KEYTRUDA (n=149) versus 50.7% of patients receiving chemotherapy (n=144); the most common Grade ≥3 TRAE was anemia, occurring in 2.0% of patients receiving KEYTRUDA compared with 18.1% of patients receiving chemotherapy. Grade ≥3 immune-mediated adverse events and infusion reactions occurred in 7.4% of patients receiving KEYTRUDA and 3.5% of patients receiving chemotherapy.

In the U.S., KEYTRUDA is the only anti-PD-1 therapy with three approved indications for patients with certain types of endometrial cancer. KEYTRUDA is indicated:

• In combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma;
• In combination with LENVIMA^® (lenvatinib), in collaboration with Eisai, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR), as determined by an FDA-authorized test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; and
• As a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Merck has a comprehensive clinical development program evaluating KEYTRUDA (both as monotherapy and in combination with chemotherapy) and sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, in endometrial cancer. As previously announced, TroFuse-005 (ClinicalTrials.gov, NCT06132958), evaluating sac-TMT, met its primary endpoints of PFS and OS, as well as its key secondary endpoint of ORR in patients with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy. These results are also being presented in a Presidential Symposium at ESMO. In addition, TroFuse-033 (NCT06952504) is enrolling patients with pMMR endometrial cancer to evaluate sac-TMT in an earlier treatment setting of first-line maintenance. The KEYNOTE-B21 trial (NCT04634877) evaluating KEYTRUDA remains ongoing for analysis in the dMMR subgroup.

About KEYNOTE-C93

KEYNOTE-C93 is a randomized, open-label Phase 3 trial (NCT05173987) evaluating KEYTRUDA monotherapy versus carboplatin plus paclitaxel in patients with dMMR advanced or recurrent endometrial cancer who have not previously been treated with prior systemic chemotherapy or who experienced recurrence after receiving prior adjuvant therapy. The trial enrolled 299 patients who were randomized to receive either:

• KEYTRUDA (400 mg) intravenously every six weeks for up to 18 cycles, or;
• Combination of paclitaxel (175 mg/m²) and carboplatin (AUC 5 or 6) every three weeks for six cycles.

The trial’s dual primary endpoints are PFS, as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS. A key secondary endpoint of the study is ORR.

About endometrial cancer

Endometrial cancer (also referred to as endometrial carcinoma) begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. More than 90% of uterine body cancers occur in the endometrium. Endometrial cancer is one of the few cancers with increasing mortality. In the U.S., it is estimated there will be approximately 68,270 patients diagnosed with endometrial cancer and approximately 14,450 patient deaths from the disease in 2026. Globally, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall.

About Merck’s research in women’s cancers

Merck is advancing research aimed at expanding treatment options for certain breast and gynecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. Breast cancer and gynecologic cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to provide options to patients facing these devastating diseases. With more than 30 clinical trials in more than 20,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. Through our portfolio and pipeline, Merck is working to address the impact of women’s cancers on patients, their families and communities globally.

About KEYTRUDA^® (pembrolizumab) injection for intravenous use, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected Indications in the U.S. for KEYTRUDA^® (pembrolizumab)

Endometrial Carcinoma

KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

See additional selected indications in the U.S. for KEYTRUDA after the Selected Safety Information.

Selected Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti– PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

Contacts

Media Contacts:

Julie Cunningham

julie.cunningham@merck.com

Heather Manhardt

heather.manhardt@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

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Sacituzumab Tirumotecan (Sac-TMT) Reduced the Risk of Death by 32% and the Risk of Disease Progression or Death by 41% Compared to Chemotherapy in Certain Patients With Advanced or Recurrent Endometrial Cancer




Sacituzumab Tirumotecan (Sac-TMT) Reduced the Risk of Death by 32% and the Risk of Disease Progression or Death by 41% Compared to Chemotherapy in Certain Patients With Advanced or Recurrent Endometrial Cancer

TroFuse-005 is the first and only global Phase 3 study of a TROP2 ADC to demonstrate improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy in these patients who have received prior platinum-based chemotherapy and anti-PD-1/L1 immunotherapy

Results from TroFuse-005 were selected for an official press briefing and will be presented during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) Congress 2026 and published simultaneously in The Lancet

Based on these data, the U.S. FDA has accepted for priority review a Biologics License Application for sac-TMT for these patients

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the pivotal Phase 3 TroFuse-005 trial evaluating sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, in patients with advanced or recurrent endometrial cancer who have received prior platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. At a pre-specified interim analysis, the study demonstrated statistically significant and clinically meaningful improvement in its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as well as its key secondary endpoint of objective response rate (ORR) compared with treatment of physician’s choice (TPC; doxorubicin or paclitaxel). TroFuse-005 is the first global Phase 3 trial and the first ADC to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients with advanced or recurrent endometrial cancer. These late-breaking data will be presented for the first time today during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) Congress 2026 [Presentation #LBA11], were selected for an official ESMO press briefing, and were published simultaneously in The Lancet.

At the time of analysis, with a median follow-up of 14.0 months, sac-TMT reduced the risk of death by 32% (HR=0.68; 95% CI, 0.55-0.84; P<0.0001), extending median OS by 6.9 months compared with TPC (19.0 months vs. 12.1 months). Sac-TMT also reduced the risk of disease progression or death by 41% (HR=0.59; 95% CI, 0.50-0.70; P<0.0001), extending median PFS by 3.3 months compared with TPC (7.2 months vs. 3.9 months). The study improved ORR by 17.8% (95% CI, 11.6–23.9; P <0.00001), double what was observed in the TPC arm (35.1% vs. 17.3%), and complete responses occurred in 6.1% of patients on the sac-TMT arm and 4.5% of patients on the chemotherapy. Responses were durable, with a median duration of response of 11.1 months (95% CI, 9.2–13.0) in the sac-TMT arm and 6.9 months (95% CI, 5.4–9.1) in the TPC arm.

“Sac-TMT is the first TROP2 ADC to demonstrate an improvement in overall survival in advanced or recurrent endometrial cancer in this setting compared to chemotherapy in a global Phase 3 trial. In addition, TroFuse-005 found a higher response rate and longer duration of response among patients treated with sac-TMT compared to chemotherapy,” said Dr. Domenica Lorusso, the study’s global lead investigator, lead investigator for ENGOT and professor of Obstetrics and Gynecology at Humanitas University and Humanitas San Pio X, Milan. “The incidence and mortality rates of endometrial cancer are increasing worldwide, and the results from TroFuse-005 have the potential to change the way we treat patients who have received prior platinum-based chemotherapy and anti-PD-1/L1 immunotherapy.”

“Sac-TMT demonstrated an improvement in overall survival of almost seven months for women with endometrial cancer who progress following treatment with platinum-based chemotherapy and anti-PD-1 therapy, a meaningful advancement for these women who face a median survival of less than a year with current therapies,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We believe sac-TMT, with its unique bifunctional linker, can become a cornerstone for the treatment of certain patients with advanced or recurrent endometrial cancer. Based on discussions with the U.S. FDA, the company is hopeful for an approval before the PDUFA date to bring sac-TMT to patients as quickly as possible.”

The safety profile was consistent with what has been observed in previously reported studies of sac-TMT; no new safety signals were observed. Treatment-related adverse events (TRAEs) of any grade occurred in 97.1% of patients treated with sac-TMT and 89.6% of patients receiving TPC. These AEs were mostly low grade and manageable with supportive care and dose modifications, with low discontinuation rates. Grade ≥3 TRAEs occurred in 54.4% and 41.4% of patients, respectively. The most common Grade ≥3 clinical safety events with sac-TMT were anemia (23.7%), neutropenia (20.1%) and oral mucositis/stomatitis (9.9%). Treatment discontinuation rate in the sac-TMT arm was 3.1% and in the TPC arm was 4.9%. Health-related quality of life was maintained over time with sac-TMT. TRAEs led to death in 0.8% of patients (N=3) in each arm.

Based on data from the TroFuse-005 trial, the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) seeking approval of sac-TMT for the treatment of adult patients with endometrial cancer who have previously received platinum containing chemotherapy and a programmed death receptor 1 (PD 1) or programmed death ligand 1 (PD L1) inhibitor, separately or in combination. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 15, 2027. Merck will also discuss these data with global regulatory authorities.

Merck’s TroFuse clinical development program for sac-TMT currently consists of 18 ongoing global Phase 3 trials across multiple tumor types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date. Ten of the Phase 3 trials are in women’s cancers, building on Merck’s deep expertise and commitment to women’s cancers research. This includes the ongoing TroFuse-033 trial in first line mismatch repair proficient endometrial cancer. The program is evaluating sac-TMT across a diverse range of tumor types, including endometrial, bladder, breast, cervical, gastric, non-small cell lung and ovarian cancers, and it spans early-to-late-stage disease as both monotherapy and in combination with immunotherapies. TroFuse-005 is among the 14 of these Phase 3 studies which aim to address unmet medical need with first-in-class opportunities.

About TroFuse-005
TroFuse-005 is a randomized, active-controlled, open-label, multicenter, global Phase 3 trial (ClinicalTrials.gov, NCT06132958) evaluating sac-TMT versus TPC in patients with endometrial carcinoma who have received prior platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy either together or separately. The trial enrolled 776 patients who were randomized to receive either sac-TMT or TPC, consisting of doxorubicin or paclitaxel. Sac-TMT (4 mg/kg) was administered on Day 1 of each two-week treatment cycle. Doxorubicin (60 mg/m²) was administered on Day 1 of each three-week treatment cycle and paclitaxel (80 mg/m²) was administered on Days 1, 8 and 15 of each four-week treatment cycle.

The study has dual primary endpoints: PFS by blinded independent central review (BICR), defined as the time from randomization to the first documented disease progression or death from any cause, and OS, defined as the time from randomization to death from any cause. A key secondary endpoint is ORR, and other secondary endpoints include duration of response, incidence of adverse events, treatment discontinuation due to adverse events and change from baseline in global health status/quality-of-life scores.

About sacituzumab tirumotecan (sac-TMT)
Sac-TMT is an investigational TROP2-directed ADC with a belotecan-derived topoisomerase I inhibitor payload and a unique bifunctional linker designed with the potential to maximize payload delivery to tumor cells and minimize payload loss while circulating in the body.

TROP2 is overexpressed on tumor cells compared to healthy cells in many common cancers, and through the TroFuse clinical development program, Merck is evaluating sac-TMT in 18 ongoing global Phase 3 trials across multiple tumor types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date. The TroFuse development program spans early-to-late-stage disease in more than nine disease areas and includes more than 15,000 patients worldwide. Numerous Phase 3 trials are exploring sac-TMT as monotherapy and in combination with immunotherapies, aiming to improve survival and quality of life for patients with advanced and earlier-stage cancers.

About endometrial cancer
Endometrial cancer (also referred to as endometrial carcinoma) begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. More than 90% of uterine body cancers occur in the endometrium. In the U.S., it is estimated there will be approximately 68,270 patients diagnosed with endometrial cancer and approximately 14,450 patient deaths from the disease in 2026. Globally, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall. Following primary treatment, patients face a risk of their cancer returning, often as distant metastasis, which is associated with poorer outcomes.

About Merck’s research in women’s cancers
Merck is advancing research aimed at expanding treatment options for certain breast and gynecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. Breast cancer and gynecologic cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to provide options to patients facing these devastating diseases. With more than 30 clinical trials in more than 20,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. Through our portfolio and pipeline, Merck is working to address the impact of women’s cancers on patients, their families and communities globally.

About the Merck and Kelun-Biotech strategic collaboration
Sac-TMT was developed by Kelun-Biotech. Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macau and Taiwan).

Merck’s focus on cancer
Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 20 novel mechanisms. With one of the largest clinical development programs across more than 25 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology.

About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Julie Cunningham

julie.cunningham@merck.com

John Infanti

john.infanti@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

PharmaEssentia to Present Early-Stage Pipeline Data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, Highlighting Immuno-Oncology Approaches for Solid Tumors




PharmaEssentia to Present Early-Stage Pipeline Data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, Highlighting Immuno-Oncology Approaches for Solid Tumors

Two posters highlight preclinical data for PEC 2001 and 3001, a myeloid checkpoint inhibitor and an immunocytokine, supporting advancement toward the clinic

Presentations underscore PharmaEssentia’s strategy to diversify its pipeline through novel immuno-oncology programs targeting both myeloid and PD-1-directed activation of anti-tumor responses

BEDFORD, Mass.–(BUSINESS WIRE)–PharmaEssentia Innovation Research Center (PIRC), a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced two poster presentations at the Society for Immunotherapy of Cancer’s (SITC) 41st Annual Meeting, taking place November 4-8 in Phoenix, Arizona.

The two presentations feature pre-clinical data from PharmaEssentia’s internal R&D portfolio, which builds on the company’s expertise in PEGylated cytokines, novel checkpoint receptor biology, and cytokine engineering technology to extend its focus beyond myeloproliferative neoplasms (MPNs) into solid tumors.

“These presentations reflect the strength of our discovery engine and our ambition to build a pipeline with MPN as its core and broader opportunities beyond,” said Lih-Ling Lin, Ph.D., Chief Scientific Officer at PharmaEssentia. “We look forward to moving our solid tumor pipeline candidates into IND-enabling and Phase 1 studies.”

Poster Presentations

Both posters will be presented during the SITC poster sessions on Friday, November 6.

Title: PEC2001, a differentiated dual LILRB1/LILRB2 antagonist, reprograms myeloid immunity and enhances anti-tumor activity

Poster Number: 411

Presenter: Ali Sepahi, Ph.D., PharmaEssentia

Key Results: PEC2001’s differentiated inhibition mechanism delivered superior selectivity, enhanced anti-tumor immune activation, and strong preclinical efficacy, supporting its potential as a best-in-class myeloid checkpoint inhibitor for solid tumors.

Title: Pre-clinical characterization of PEC3001, a PD-1 targeted IL-2Rα-active IL-2 immunocytokine with potent anti-tumor activity and a favorable safety profile.

Poster Number: 897

Presenter: John Huck, Ph.D., PharmaEssentia

Key Results: PEC3001 selectively enhances anti-tumor T-cell activity through PD-1-directed targeting and IL-2Rα engagement, while minimizing systemic immune activation, supporting advancement into first-in-human clinical development.

About PharmaEssentia

PharmaEssentia Corporation, headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia, visit the website or LinkedIn.

PharmaEssentia Innovation Research Center (PIRC), is a subsidiary of PharmaEssentia Corporation. PIRC leads the discovery and preclinical research supporting the early-stage pipeline in the United States. For more information about PIRC, visit their website or LinkedIn.

Contacts

Media Contacts
Muriel Huang

Director, Investor Relations and Corporate Communications

muriel_huang@pharmaessentia.com

Melia Matthews

Manager, Investor Relations and Corporate Communications

melia_matthews@pharmaessentia.com

Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling




Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling

CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM) today announced that its xR assay has received certification under the European Union’s In Vitro Diagnostic Regulation (IVDR) as a Class C in vitro diagnostic device. The certification covers Tempus’ quality management system for “next-generation sequencing devices for cancer genomic profiling to support clinical management.”

xR detects gene rearrangements and specific splice variants in solid tumor tissue to support clinical management. A published study demonstrated that combining Tempus RNA and DNA testing increases detection of clinically actionable gene fusions compared with DNA testing alone.

IVDR certification supports continued access to xR in the EU beyond 2028, the transition deadline for eligible legacy Class C devices, and provides biopharma partners with an IVDR-certified testing platform to support clinical studies.

“Securing our European IVDR certification for xR reinforces our commitment to meeting the highest regulatory standards globally,” said Lauren Silvis, SVP of External Affairs at Tempus. “This achievement establishes a strong regulatory foundation in Europe as we work to expand access to our advanced RNA sequencing tools for healthcare providers, biopharma partners and cancer patients across the region.”

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the expected outcomes and benefits of Tempus xR and IVDR certification. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2026, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Contacts

Hanah Heintzelman

media@tempus.com