Pfizer Oncology to Showcase New Data from Innovative Science That Address Patient Needs at ASCO 2019 Annual Meeting

Data spans 10 therapies across 10 types of cancer

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) will present data across its industry-leading
oncology portfolio, covering multiple tumor types and mechanisms of
action at the 55th Annual Meeting of the American Society of Clinical
Oncology (ASCO) in Chicago from May 31-June 4, 2019. Data will highlight
Pfizer’s cutting-edge approach, expertise in precision medicine and work
in immunotherapy combinations, including company-sponsored and
collaborative research studies.

“The data presented at this year’s ASCO showcase our continued
commitment to follow the science, whether it’s expanding our approved
medicines for breast and prostate cancers into new populations and lines
of therapy, or exploring the important role of biomarkers and
immunotherapy combinations,” said Dany Habr, M.D., Chief Medical
Officer, Pfizer Oncology. “We look forward to both sharing our exciting
data in these and other tumor types, as well as connecting with our
research partners to determine how we can continue to work
collaboratively to bring transformative therapies to our cancer
patients.”

The research to be presented includes new insights on Pfizer’s marketed
therapies, including IBRANCE® (palbociclib), XTANDI®
(enzalutamide), TALZENNA® (talazoparib), BOSULIF® (bosutinib),
INLYTA® (axitinib) and BAVENCIO® (avelumab), which
represent Pfizer Oncology’s long-standing legacy of developing
innovative therapies for patients in need, as well as its ongoing
commitment to addressing the needs of cancer patients across gender,
ethnicity and tumor type. For example, Pfizer will present real-world
data on the use of IBRANCE for the treatment of men with metastatic
breast cancer (MBC).

“At this year’s ASCO, I am particularly excited that we’ll share data
from new initiatives such as the oral presentation of talazoparib in
breast cancer or other solid tumors. This builds on a productive year
with the approval of four new oncology treatments, three biosimilars and
three new indications, including one based on real-world evidence,” said
Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer
Global Product Development. “We are proud to have one of the broadest
oncology portfolios in the industry, and a research philosophy that puts
patients first, embraces new approaches and showcases innovative
thinking.”

Key Pfizer-sponsored, investigator-sponsored and collaborative research
abstracts leveraging the depth of Pfizer’s scientific advances include:

  • A poster presentation on real-world evidence of male breast cancer
    patients treated with IBRANCE in combination with endocrine therapy
    (Abstract 1055).
  • An external investigator-sponsored oral presentation on a Phase 2
    trial examining TALZENNA beyond BRCA, specifically as
    monotherapy in BRCA1 and BRCA2 wild-type patients with
    advanced HER2-negative breast cancer or other solid tumors with a
    mutation in homologous recombination (HR) pathway genes
    (Investigator-sponsored abstract 3006).
  • Biomarker analyses from JAVELIN Renal 101 that studied BAVENCIO plus
    INLYTA vs. sunitinib in advanced renal cell carcinoma (aRCC) (Abstract
    101).
  • An external collaborative research presentation on genomic markers of
    early progression on fulvestrant with or without IBRANCE for ER+
    advanced breast cancer in the PALOMA-3 trial (Collaborative research
    abstract 1010).

Details for the Pfizer-sponsored, investigator-sponsored and
collaborative research oral presentations are below:

             
Title/Abstract Number     Date/Time (CDT)     Location
(Abstract 101)

Biomarker Analyses from JAVELIN Renal 101: Avelumab + Axitinib (A
+ Ax) vs Sunitinib (S) in Advanced Renal Cell Carcinoma (aRCC)

 

Choueiri TK

    Saturday, June 1

8:12 AM – 8:24 AM

    Hall D1
(Abstract 1010)

Genomic Markers of Early Progression on Fulvestrant with or
without Palbociclib for ER+ Advanced Breast Cancer in the PALOMA-3
Trial

 

O’Leary B

    Saturday, June 1

3:12 PM – 3:24 PM

    Hall D1
(Abstract 3006)

Talazoparib Beyond BRCA: A Phase II Trial of Talazoparib
Monotherapy in BRCA1 and BRCA2 Wild-Type Patients
with Advanced HER2-Negative Breast Cancer or Other Solid Tumors
with a Mutation in Homologous Recombination (HR) Pathway Genes

 

Gruber J

    Monday, June 3

10:00 AM – 10:12 AM

    S406
(Abstract 5502)

Phase 2, Two-Group, Two-Stage Study of Avelumab in Patients (Pts)
with Microsatellite Stable (MSS), Microsatellite Instable (MSI)
and Polymerase Epsilon (POLE) Mutated Recurrent/Persistent
Endometrial Cancer (EC)

 

Konstantinopoulos PA

    Monday, June 3

1:39 PM – 1:51 PM

    S406
(Abstract 1007)

A Randomized Phase II Study of Palbociclib plus Exemestane with
GNRH Agonist versus Capecitabine in Premenopausal Women with
Hormone Receptor-Positive Metastatic Breast Cancer (KCSG-BR 15-10,
NCT02592746)

 

Park YH

    Tuesday, June 4

11:45 AM – 11:57 AM

    Hall D1
       

Please see a complete list of Pfizer-sponsored abstracts featuring data
on our broad pipeline of biologics and small molecules at https://www.pfizer.com/news/press-kits/oncology.

Learn more about how developing new medicines and supporting people with
cancer is personal for Pfizer Oncology at https://www.pfizer.com/news/press-kits/oncology.

Please see full US
Prescribing Information
 and Medication
Guide
 for BAVENCIO® (avelumab) available at http://www.Bavencio.com.

Please see full Prescribing Information for INLYTA®
(axitinib) at www.Inlyta.com.

Please see full Prescribing Information for BOSULIF®
(bosutinib) at www.Bosulif.com.

Please see full Prescribing Information for IBRANCE®
(palbociclib) at www.Ibrance.com.

Please see full Prescribing Information for TALZENNA® (talazoparib)
at www.Talzenna.com.

Please see full Prescribing Information for XTANDI®
(enzalutamide) at www.Xtandi.com.

About Pfizer Oncology
At Pfizer Oncology, we are committed
to advancing medicines wherever we believe we can make a meaningful
difference in the lives of patients. Today, Pfizer Oncology has an
industry-leading portfolio of 18 approved innovative cancer medicines
and biosimilars across more than 20 indications, including breast,
prostate, kidney, lung and hematology. Pfizer Oncology is striving to
change the trajectory of cancer.

Pfizer Inc: Working together for a healthier world®
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. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best-known consumer health care products. 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 150 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 Twitter at @Pfizer and @Pfizer_NewsLinkedIn,
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and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of
May 15, 2019. 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’s marketed oncology portfolio, including, among others,
BAVENCIO (avelumab), INLYTA (axitinib), IBRANCE (palbociclib), TALZENNA
(talazoparib) and XTANDI (enzalutamide), including their potential
benefits, 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 Pfizer’s
oncology portfolio; the uncertainties inherent in research and
development, including, without limitation, the ability to meet
anticipated clinical trial commencement and completion dates and
regulatory submission dates, as well as the possibility of unfavorable
clinical trial results, including unfavorable new clinical data and
additional analyses of existing clinical data; the risk that clinical
trial data are subject to differing interpretations, and, even when we
view data as sufficient to support the safety and/or effectiveness of a
product candidate, regulatory authorities may not share our views and
may require additional data or may deny approval altogether; whether
regulatory authorities will be satisfied with the design of and results
from our clinical studies; whether and when drug applications may be
filed in any jurisdictions for any potential indication for Pfizer’s
oncology products and product candidates; whether and when applications
that are pending or any such other applications that may be filed for
any of Pfizer’s oncology products and product candidates may be approved
by regulatory authorities, which will depend on the assessment by such
regulatory authorities of the benefit-risk profile suggested by the
totality of the efficacy and safety information submitted, and, if
approved, whether any such oncology products will be commercially
successful; decisions by regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential
of Pfizer’s oncology products and product candidates; and competitive
developments. A further description of risks and uncertainties can be
found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in its subsequent reports on Form 10-Q, including
in the sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at
www.sec.gov
and
www.pfizer.com.

Contacts

Pfizer Media:
Jessica Smith
(212) 733-6213
Jessica.M.Smith@pfizer.com

Pfizer Investors:
Ryan Crowe
(212) 733-8160
Ryan.Crowe@pfizer.com