Gilead and Kite Oncology to Highlight Advances Supporting New Innovations in Cancer Care at the ASCO Annual Meeting

Gilead and Kite Oncology to Highlight Advances Supporting New Innovations in Cancer Care at the ASCO Annual Meeting




Gilead and Kite Oncology to Highlight Advances Supporting New Innovations in Cancer Care at the ASCO Annual Meeting

Late-Breaking TROPiCS-02 Study Results in Heavily Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients to be Featured in ASCO Press Program

New Sub-Analysis from Kite’s ZUMA-7 CAR T-cell Therapy Study in Patients Aged 65+ and Data by Tumor Burden Characteristics in Second-Line Large B-cell Lymphoma to be Presented

Diverse Hematologic Research to be Highlighted by Phase 1b Data in MDS and AML and New Real-World Outcomes by Race and Ethnicity for CAR T-cell Therapy

FOSTER CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced that more than 20 abstracts, including two oral presentations and four poster discussions, will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. These data highlight promising targets across diverse tumor types and blood cancers, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic triple-negative breast cancer (TNBC), large B-cell lymphoma (LBCL), myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL).

Gilead has built a diverse oncology pipeline guided by our strategic framework, with a focus on depth and breadth to address the greatest gaps in care for people with overlooked, underserved and difficult-to-treat cancers,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Anchored by our Trop-2 directed antibody-drug conjugate, CAR T-cell therapies and our investigational anti-CD47 antibody, these data reinforce the potential of our transformative science across multiple cancers.”

Driving Scientific Innovation in Breast Cancers with High Unmet Need

A late-breaking presentation on the TROPiCS-02 study will examine the investigational use of Gilead’s antibody-drug conjugate in heavily pre-treated patients with HR+/HER2- unresectable locally advanced or metastatic breast cancer, a population with significantly limited treatment options following endocrine resistance. The final data from the landmark ASCENT study in second-line metastatic TNBC will also be presented.

Advancing an Industry-Leading CAR T-cell Therapy Portfolio

New analyses of the Phase 3 ZUMA-7 trial will highlight results in patients aged 65+, as well as data on pre-treatment tumor burden characteristics and clinical outcomes for the first and only CAR T-cell therapy approved for initial treatment of relapsed/refractory LBCL. Additional presentations include real-world outcomes by race and ethnicity for Kite’s CAR T-cell therapy in LBCL and longer-term data from the ZUMA-2 and ZUMA-3 studies assessing the durability of response to Kite’s CAR T-cell therapy in relapsed/refractory MCL and relapsed/refractory adult ALL, respectively.

At Kite, our singular focus is on developing cell therapies to treat and potentially cure cancers,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. “Our data at ASCO span multiple types of blood cancer and stages of treatment, reinforcing how our therapies are changing the way cancer is treated.”

Furthering Potential Treatment Approaches in MDS and AML

Results of our Phase 1b study evaluating an investigational anti-CD47 antibody in combination with azacitidine in high-risk MDS and in TP53-mutant AML will be presented. MDS and AML are blood cancers which have seen limited therapeutic advancements in the past decade, and Gilead data being presented at ASCO will reinforce the potential of harnessing the innate immunity of macrophages.

Summary of Presentations

Accepted abstracts at the 2022 ASCO Annual Meeting include (all times CDT):

Abstract Disposition

Abstract Title

Breast Cancer

Abstract #LBA1001 (Oral Session)

Saturday, June 4

1:27 PM

Primary Results from TROPiCS-02: A Randomized Phase 3 Study of Sacituzumab Govitecan (SG) versus Treatment of Physician’s Choice (TPC) in Patients with Hormone Receptor-Positive/HER2-Negative (HR+/HER2-) Advanced Breast Cancer

Abstract #1071

Monday, June 6

8:00 AM

Sacituzumab Govitecan (SG) versus Treatment of Physician’s Choice (TPC) in Patients with Previously Treated Metastatic Triple-Negative Breast Cancer (mTNBC): Final Results from the Phase 3 ASCENT Study

Abstract #1076

Monday, June 6

8:00 AM

Exposure-Response Analyses of Sacituzumab Govitecan (SG) Efficacy and Safety in Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)

Abstract #1075

Monday, June 6

8:00 AM

Real-World Treatment Patterns and Outcomes among 2nd Line (2L) and 3rd Line (3L) Metastatic Triple-Negative Breast Cancer (mTNBC) Patients in England Using the Cancer Analysis System (CAS)

Myelodysplastic Syndrome

Abstract #7017 (Poster Discussion)

Saturday, June 4

1:15 PM

Magrolimab in Combination with Azacitidine for Untreated Higher-Risk Myelodysplastic Syndromes (HR-MDS): 5F9005 Phase 1b Study Results

Abstract #7054

Saturday, June 4

8:00 AM

Impact of Magrolimab Treatment in Combination with Azacitidine on Red Blood Cells in Higher-Risk Myelodysplastic Syndrome (HR-MDS) Patients

ePublication #e19062

Clinical Outcomes Associated with Azacitidine Monotherapy for Treatment-Naïve Higher-Risk Myelodysplastic Syndrome: A Systematic Literature Review and Meta-Analysis

Acute Myeloid Leukemia

Abstract #7020 (Poster Discussion)

Saturday, June 4

1:15 PM

Tolerability and Efficacy of the First-in-Class Anti-CD47 Antibody Magrolimab Combined with Azacitidine in Frontline TP53m AML Patients: Phase 1b Results

ePublication #e19020

Treatment Outcomes for Newly Diagnosed, Untreated TP53-Mutated Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis

B-cell Lymphomas

Abstract #7571 (Oral Session)

Friday, June 3

3:12 PM

Real-World Outcomes of Axicabtagene Ciloleucel (Axi-Cel) for the Treatment of Large B-cell Lymphoma (LBCL) by Race and Ethnicity

Abstract #7548

Saturday, June 4

8:00 AM

Clinical and Patient-Reported Outcomes (PROs) in a Phase 3, Randomized, Open-Label Study Evaluating Axicabtagene Ciloleucel (Axi-Cel) versus Standard-of-Care (SOC) Therapy in Elderly Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL) (ZUMA-7)

Abstract #7565

Saturday, June 4

8:00 AM

Association of Pretreatment (Pretx) Tumor Characteristics and Clinical Outcomes Following Second-Line (2L) Axicabtagene Ciloleucel (Axi-Cel) versus Standard of Care (SOC) in Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL)

Abstract #7567

Saturday, June 4

8:00 AM

Axicabtagene Ciloleucel (Axi-Cel) in Combination with Rituximab (Rtx) for the Treatment of Refractory Large B-cell Lymphoma (R-LBCL): Outcomes of the Phase 2 ZUMA-14 Study

Abstract #7555

Saturday, June 4

8:00 AM

Quality-Adjusted Time without Symptoms or Toxicities (Q-Twist) Analysis of ZUMA-7, a Randomized Controlled Trial of Axicabtagene Ciloleucel versus Standard of Care for Second-Line Large B-cell Lymphoma

Abstract #TPS7579

Saturday, June 4

8:00 AM

KITE-363: A Phase 1 Study of an Autologous Anti-CD19/CD20 Chimeric Antigen Receptor (CAR) T-Cell Therapy in Patients with Relapsed/Refractory (R/R) B-cell Lymphoma (BCL)

ePublication #e19558

Patient Preferences for Second-Line Treatment Options in Diffuse Large B-cell Lymphoma: A Discrete Choice Experiment

Mantle Cell Lymphoma

Abstract #7518 (Poster Discussion)

Saturday, June 4

3:00 PM

Three-Year Follow-Up of Outcomes with KTE-X19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma in ZUMA-2

Acute Lymphoblastic Leukemia

Abstract #7010 (Poster Discussion)

Saturday, June 4

1:15 PM

Two-Year Follow-Up of KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Adult Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) in ZUMA-3

Non-Small Cell Lung Cancer

Abstract #TPS9149

Monday, June 6

8:00 AM

EVOKE-01: A Phase 3 Study of Sacituzumab Govitecan (SG) versus Docetaxel in Patients with Non-Small Cell Lung Cancer (NSCLC) Progressing On or After Platinum-Based Chemotherapy and Checkpoint Inhibitors

Abstract #TPS9146

Monday, June 6

8:00 AM

EVOKE-02: A Phase 2 Study of Sacituzumab Govitecan Plus Pembrolizumab with or without Platinum Chemotherapy in First-Line Metastatic Non-Small Cell Lung Cancer (NSCLC)

Advanced Solid Tumors

Abstract #2566

Sunday, June 5

8:00 AM

Phase 1b Study of GS-3583, A Novel FLT3 Agonist Fc Fusion Protein, in Patients with Advanced Solid Tumors

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite’s singular focus is cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company.

Forward-Looking Statements

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Tecartus, Trodelvy, Yescarta and magrolimab; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

Gilead, the Gilead logo, Kite and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

Contacts

Jacquie Ross, Investors

investor_relations@gilead.com

Nathan Kaiser, Gilead Media

nathan.kaiser@gilead.com

Anna Padula, Kite Media

apadula@kitepharma.com