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Pfizer Oncology to Present Data Across 13 Different Types of Cancer at ASCO 2017 Annual Meeting

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Thursday, May 18th 2017 at 12:00am UTC

Data to be presented on more than 15 clinical-stage assets in both
solid and hematologic tumors

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced it will present more than 50
abstracts, involving more than 15 clinical-stage assets across solid and
hematologic tumors and 12 mechanisms of action, at the 53rd
Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago from June 2-6, 2017.

New data will be featured in nine oral presentations from
company-sponsored clinical trials, including a late-breaker on the
investigational compound dacomitinib in locally advanced or metastatic
non-small cell lung cancer (NSCLC) with epidermal growth factor receptor
(EGFR)-activating mutation, which will be featured in the official ASCO
press program. Other abstracts provide insights into treating lung,
breast, kidney and prostate cancers and hematologic malignancies across
marketed and investigational Pfizer therapies, including immuno-oncology
(IO) and IO combinations.

“While tremendous strides in cancer are made every day, it’s clear there
is so much more to achieve on behalf of patients,” said Liz Barrett,
Global President and General Manager, Pfizer Oncology. “Through our
cutting-edge science and a desire to work collaboratively, Pfizer
Oncology continues to break boundaries in cancer care and is helping to
redefine life with cancer.”

“Our presentations at this year’s ASCO cover a broad range of drug
development: from Phase 1 to Phase 3; from immunotherapy to targeted
agents and antibody-drug conjugates; from disease areas in which we have
extensive experience to disease areas that we are entering for the first
time,” said Mace Rothenberg, MD, Chief Development Officer, Oncology,
Pfizer Global Product Development. “We are very excited about sharing
these results with the oncology community and working with them to
realize the full potential of our medicines.”

Hematology Highlights

New clinical data from a broad range of therapies will be presented,
providing insights into potential treatments for several blood cancers,
including acute and chronic leukemias.

Key abstracts in investigational settings include:

  • Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia
    (CML): initial results from the phase 3 BFORE trial
  • Factors associated with allogeneic hematopoietic stem cell
    transplantation outcomes in patients with relapsed/refractory acute
    lymphoblastic leukemia treated with inotuzumab ozogamicin versus
    conventional chemotherapy

Lung Cancer Highlights

New data will be highlighted for two investigational NSCLC therapies
that target EGFR and anaplastic lymphoma kinase (ALK) genetic
alterations and reinforce the increasingly important role that
biomarker-driven treatments are playing across lung cancers.

Key abstracts include:

  • Dacomitinib versus gefitinib for the first-line treatment of advanced
    EGFR mutation positive non-small cell lung cancer (ARCHER 1050): A
    randomized, open-label phase 3 trial
  • Efficacy and safety of lorlatinib in ALK+ non-small-cell lung cancer
    patients with ≥1 prior ALK tyrosine kinase inhibitor: A phase I/II
    study

Breast Cancer Highlights

Pfizer is also working to expand treatment options for patients with a
certain type of metastatic breast cancer with talazoparib, an
investigational, dual-mechanism PARP inhibitor. Results from a Phase 2
study of talazoparib will be presented. In addition, updated overall
survival data from the PALOMA-1 study of IBRANCE®
(palbociclib) will be shared.

Key abstracts include:

  • Results of a phase 2 study of talazoparib following platinum or
    multiple cytotoxic regimens in advanced breast cancer patients with
    germline BRCA1/2 mutations (ABRAZO)
  • Overall survival results from the randomized phase 2 study of
    palbociclib in combination with letrozole vs letrozole alone for
    first-line treatment of ER+/HER2– advanced breast cancer (PALOMA-1;
    TRIO-18)

Renal Cell Carcinoma Highlights

For the past 10 years, Pfizer has been a leader in developing new
treatments for patients with advanced kidney cancer. Building on this
experience, Pfizer is sharing early data from a novel immuno-therapy
combination with INLYTA® (axitinib) and PD-L1 inhibitor
avelumab in advanced renal cell carcinoma (RCC), being developed in
collaboration with Merck KGaA, Darmstadt, Germany. Further, a
sub-analysis from the use of SUTENT® (sunitinib) in the
adjuvant RCC setting will also be presented.

Key abstracts in investigational settings include:

  • First-line avelumab + axitinib therapy in patients with advanced renal
    cell carcinoma (aRCC): results from a phase 1b trial
  • A phase 3 trial of adjuvant sunitinib in patients with high-risk renal
    cell carcinoma (RCC): validation of the 16-gene Recurrence Score in
    stage III patients

Prostate Cancer Highlights

New clinical data provide insights into combination of agents most
likely to benefit patients with metastatic castration-resistant prostate
cancer (CRPC) following PSA progression with enzalutamide, adding to the
robust and rigorous clinical trial program of XTANDI®
(enzalutamide) in metastatic CRPC and other prostate cancer populations.

Key abstracts include:

  • A phase 4, randomized, double-blind, placebo-controlled study of
    continued enzalutamide post prostate-specific antigen progression in
    men with chemotherapy-naïve metastatic castration-resistant prostate
    cancer
 

Pfizer-Sponsored Studies Oral Presentation Planner

Title/Abstract Number   Date/Time (CDT)   Location

(Abstract 1001) Overall survival results from the randomized
phase 2 study of palbociclib in combination with letrozole (L) vs
letrozole alone for first-line treatment of ER+/HER2– advanced
breast cancer (PALOMA-1; TRIO-18)

Finn R

 

Saturday, June 3
1:27 – 1:39 p.m.

  Hall D1

(Abstract 5004) A phase 4, randomized, double-blind,
placebo-controlled study of continued enzalutamide post
prostate-specific antigen progression in men with
chemotherapy-naïve metastatic castration-resistant prostate cancer

Attard
G

 

Saturday, June 3
2:27 – 2:39 p.m.

  Hall B1

(Abstract 1007) Final results of a phase 2 study of talazoparib
following platinum or multiple cytotoxic regimens in advanced
breast cancer patients with germline BRCA1/2 Mutations (ABRAZO)

Turner
NC

 

Saturday, June 3
3:27 – 3:39 p.m.

  Hall D1

(Abstract 4504) First-line avelumab + axitinib therapy in
patients with advanced renal cell carcinoma: results from a phase
1b trial

Choueiri TK

 

Monday, June 5
9:12 – 9:24 a.m.

  Arie Crown Theater

(Abstract 4508) Phase 3 trial of adjuvant sunitinib in patients
with high-risk renal cell carcinoma (RCC): Validation of the
16-gene Recurrence Score in stage III patients

Escudier B

 

Monday, June 5
10:24 – 10:36 a.m.

  Arie Crown Theater

(Abstract 7002) Bosutinib vs imatinib for newly diagnosed
chronic myeloid leukemia (CML): initial results from the BFORE
trial

Cortes JE

 

Tuesday, June 6
10:09 – 10:21 a.m.

  E450ab

(Abstract 9006) Efficacy and safety of lorlatinib in ALK+
non-small-cell lung cancer patients with ≥1 prior ALK tyrosine
kinase inhibitor: A phase I/II study

Shaw A

 

Tuesday, June 6
11:45 – 11:57 a.m.

  Hall D1

(Abstract 7007) Factors associated with allogeneic
hematopoietic stem cell transplantation outcomes in patients with
relapsed/refractory acute lymphoblastic leukemia treated with
inotuzumab ozogamicin versus conventional chemotherapy

Kebriaei
P

 

Tuesday, June 6
11:57 a.m. – 12:09 p.m.

  E450ab

(Abstract LBA9007) Dacomitinib versus gefitinib for the
first-line treatment of advanced EGFR mutation positive non-small
cell lung cancer (ARCHER 1050): A randomized, open-label phase 3
trial

Mok T

 

Tuesday, June 6
11:57 a.m. – 12:09 p.m.

  Hall D1
   

For a complete list of Pfizer-sponsored abstracts featuring data on our
broad pipeline of biologics and small molecules, please visit: http://www.pfizer.com/files/news/2017_ASCO_Pfizer_Data_Presentation_Fact_Sheet_FINAL_4.20.17.pdf

Learn more about how Pfizer Oncology is applying innovative approaches
to improve the outlook for people living with cancer at http://www.pfizer.com/research/therapeutic_areas/oncology.

Additionally, Pfizer and Astellas announced the discontinuation of the
planned ENDEAR trial (A Phase III, Randomized, International Study
Comparing the Efficacy and Safety of Enzalutamide in Combination With
Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel
in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast
Cancer); no patients were ever enrolled in the trial. Furthermore, the
companies have decided that based on the data from the enzalutamide
Phase 2 HER2+ and ER/PR+ breast cancer studies, there will not be
follow-on Phase 3 studies at this time.

*Enzalutamide is developed through a collaboration between Pfizer and
Astellas and commercialized under the brand name XTANDI®.

Dacomitinib, lorlatinib, inotuzumab ozogamicin and talazoparib are
investigational agents and have not been approved by any regulatory
agencies.

Please see full Prescribing Information for BOSULIF®
(bosutinib) at http://labeling.pfizer.com/ShowLabeling.aspx?id=884.

Please see full Prescribing Information for IBRANCE®
(palbociclib) at http://labeling.pfizer.com/ShowLabeling.aspx?id=2191.

Please see full Prescribing Information for INLYTA®
(axitinib) at http://labeling.pfizer.com/ShowLabeling.aspx?id=759.

Please see full Prescribing Information for SUTENT®
(sunitinib malate), Including Boxed Warning, at http://labeling.pfizer.com/showlabeling.aspx?id=607.

Please see full Prescribing Information for XTANDI® (enzalutamide)
at https://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf?v=1.

About Pfizer Oncology

Pfizer Oncology is committed to pursuing innovative treatments that have
a meaningful impact on those living with cancer. As a leader in oncology
speeding cures and accessible breakthrough medicines to patients, Pfizer
Oncology is helping to redefine life with cancer. Our strong pipeline of
biologics, small molecules and immunotherapies, one of the most robust
in the industry, is studied with precise focus on identifying and
translating the best scientific breakthroughs into clinical application
for patients across a wide range of cancers. By working collaboratively
with academic institutions, individual researchers, cooperative research
groups, governments and licensing partners, Pfizer Oncology strives to
cure or control cancer with its breakthrough medicines. Because Pfizer
Oncology knows that success in oncology is not measured solely by the
medicines you manufacture, but rather by the meaningful partnerships you
make to have a more positive impact on people’s lives.

Pfizer Inc.: Working together for a healthier worldTM

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 healthcare products. Our global portfolio
includes medicines and vaccines as well as many of the world’s
best-known consumer healthcare 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, Pfizer has 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 @PfizerNews,
LinkedIn,
YouTube
and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE:

The information contained in this release is as of May 17, 2017.
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’s
marketed and investigational oncology portfolio, including its 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 products; the uncertainties inherent in research and
development, including the ability to meet anticipated clinical study
commencement and completion dates and regulatory submission dates, as
well as the possibility of unfavorable study results, including
unfavorable new clinical data and additional analyses of existing
clinical data; risks associated with initial 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
indications for Pfizer’s oncology products and product candidates;
whether and when any drug applications that are pending or that may be
filed 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; 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, 2016 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 Inc.
Media:
Sally Beatty, 212-733-6566
or
Investors:
Chuck
Triano, 212-733-3901

Source: Pfizer Inc.

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