Data to be presented on more than 15
clinical-stage assets in both solid and hematologic tumors
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 31:27 - 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
cancerAttard G
Saturday, June 32:27 - 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 33:27 - 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 trialChoueiri TK
Monday, June 59:12 - 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
patientsEscudier B
Monday, June 510:24 - 10:36 a.m.
Arie Crown Theater
(Abstract 7002) Bosutinib vs imatinib
for newly diagnosed chronic myeloid leukemia (CML): initial results
from the BFORE trialCortes JE
Tuesday, June 610:09 - 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 studyShaw
A
Tuesday, June 611:45 - 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
chemotherapyKebriaei P
Tuesday, June 611:57 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 trialMok T
Tuesday, June 611:57 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170517006435/en/
Pfizer Inc.Media:Sally Beatty, 212-733-6566orInvestors:Chuck
Triano, 212-733-3901
Pfizer (NYSE:PFE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Sep 2023 to Sep 2024