Data spans targeted and immuno-therapies across
17 cancer types
JAVELIN Bladder 100 Study to be presented in
Plenary Session and featured in the official Press Program
Pfizer Inc. (NYSE: PFE) today announced that new data from
clinical trials of 18 approved and investigational medicines will
be presented virtually at the ASCO20 Virtual Scientific Program,
from May 29-May 31. The data that will be presented build on
Pfizer’s strong track record in oncology by providing new insights
in areas like breast, colorectal and genitourinary cancers, which
include bladder, prostate, and kidney cancer. Data from Pfizer’s
early stage pipeline, including a novel anti-HER2 antibody-drug
conjugate, will also be presented as Pfizer aims to transform the
cancer treatment landscape well into the future.
“Our data presentations will highlight the depth and breadth of
our cancer portfolio, including our current medicines and new
generation of potential therapies,” said Chris Boshoff, M.D.,
Ph.D., Chief Development Officer, Oncology, Pfizer Global Product
Development. “We are particularly excited to share the first
presentation of detailed overall survival results from the JAVELIN
Bladder 100 trial of BAVENCIO and the final overall survival data
from the PROSPER trial of XTANDI. These data will support our
rapidly expanding efforts in bladder cancer and add to the growing
body of clinical evidence generated with XTANDI in prostate
cancer.”
New data will be featured in nine oral presentations, including
a Plenary Session presentation of data from the JAVELIN Bladder 100
trial evaluating BAVENCIO® (avelumab) as a first-line maintenance
treatment for locally advanced or metastatic urothelial carcinoma
(UC). Additional data provide insights on Pfizer’s medicines,
including IBRANCE® (palbociclib), BRAFTOVI® (encorafenib), XTANDI®
(enzalutamide) and lorlatinib, as well as its cutting-edge,
investigational compounds, including a HER2-targeted antibody-drug
conjugate in patients with solid tumors. BAVENCIO is being
developed and commercialized in collaboration with Merck KGaA,
Darmstadt, Germany. As part of a global agreement, Pfizer and
Astellas jointly develop and commercialize XTANDI.
To help interested non-scientists better understand the latest
research, Pfizer has also developed summaries in non-technical
language for results of company-sponsored studies being presented
in the ASCO20 Virtual Scientific Program called “abstract plain
language summaries (APLS).” Those interested in learning more can
visit www.Pfizer.com/apls to access the summaries directly starting
May 29.
Key presentations featuring Pfizer medicines in the ASCO20
Virtual Scientific Program include:
Pfizer-Sponsored Studies
Plenary Session Oral Presentation
(Abstract LBA1)
Sunday, May 31, 1 pm ET
Maintenance avelumab + best supportive
care (BSC) versus BSC alone after platinum-based first-line (1L)
chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder
100 phase 3 interim analysis.
Powles T
Oral Presentation (Abstract 4001)
Encorafenib plus cetuximab with or without
binimetinib for BRAF V600E metastatic colorectal cancer: updated
survival results from a randomized, three-arm, phase 3 study versus
choice of either irinotecan or FOLFIRI plus cetuximab (BEACON
CRC)
Kopetz S
Poster Discussion (Abstract 5515)
Final overall survival (OS) from PROSPER:
A phase 3, randomized, double-blind, placebo (PBO)-controlled study
of enzalutamide (ENZA) in men with nonmetastatic
castration-resistant prostate cancer (nmCRPC)
Sternberg CN
Poster Presentation (Abstract 1039)
A phase 1 dose escalation study evaluating
the safety and tolerability of a novel anti-HER2 antibody-drug
conjugate (PF-06804103) in patients with HER2-positive solid
tumors
Meric-Bernstam F
Poster Presentation (Abstract 5080)
Axitinib plus pembrolizumab in patients
with advanced renal cell carcinoma: Long term efficacy and safety
from a phase 1b study
Atkins MB
Investigator Sponsored Studies and
Clinical Research Collaborations
Oral Presentation (Abstract 1010)
Prognostic impact of ESR1 mutations in ER+
HER2- MBC patients prior treated with first line AI and
palbociclib: An exploratory analysis of the PADA-1 trial
Bidard FC
Oral Presentation (Abstract 10504)
Phase 1 trial of lorlatinib in patients
with ALK-driven refractory or relapsed neuroblastoma: A New
Approaches to Neuroblastoma Consortium study
Goldsmith KC
Oral, poster discussion, and poster sessions, as well as
track-based clinical science symposia, will be available on demand
for registered participants beginning Friday, May 29 at 8:00 AM ET.
A complete list of Pfizer-sponsored abstracts is available at
https://www.pfizer.com/news/press-kits/oncology.
Merck KGaA, Darmstadt, Germany, and Pfizer have a global
strategic alliance to jointly develop and commercialize
BAVENCIO.
As part of a global agreement, Pfizer and Astellas jointly
develop and commercialize XTANDI. The companies jointly
commercialize XTANDI in the United States and Astellas has
responsibility for manufacturing and all additional regulatory
filings globally, as well as commercializing XTANDI outside the
United States.
Prescribing Information for Pfizer Medicines
Please see full US Prescribing Information and Medication Guide
for BAVENCIO® (avelumab) available at http://www.Bavencio.com.
Please see full Prescribing Information for BRAFTOVI®
(encorafenib) at www.braftovihcp.com.
Please see full Prescribing Information for IBRANCE®
(palbociclib) at www.Ibrance.com.
Please see full Prescribing Information for INLYTA® (axitinib)
at www.Inlyta.com.
Please see full Prescribing Information for LORBRENA®
(lorlatinib) at www.Lorbrena.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 22 approved innovative cancer medicines and
biosimilars across more than 30 indications, including breast,
prostate, kidney and lung cancers, as well as leukemia and
melanoma.
Pfizer Inc.: 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 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_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of May 12, 2020. 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
oncology portfolio of marketed and investigational therapies,
including BAVENCIO (avelumab), BRAFTOVI (encorafenib), IBRANCE
(palbociclib), INLYTA (axitinib), lorlatinib and XTANDI
(enzalutamide) and an anti-HER2 antibody-drug conjugate, 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 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; 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 drug applications may be filed in any
jurisdictions for any potential indication for Pfizer’s oncology
products and product candidates; whether and when any such
applications that may be pending or filed may be approved by
regulatory authorities, 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 any such products 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 Pfizer’s oncology products and product candidates; the impact of
COVID-19 on our business, operations and financial results; 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, 2019 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.
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Pfizer Media: Jessica Smith (212) 733-6213
Jessica.M.Smith@pfizer.com Pfizer Investor: Ryan Crowe (212)
733-8160 Ryan.Crowe@pfizer.com
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