Data span 13 therapies across 16 types of cancer aimed at
transforming patient care
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. today announced that new data from its diversified portfolio
of marketed and investigational oncology medicines will be presented at
the 54th Annual Meeting of the American Society of Clinical
Oncology (ASCO) in Chicago from June 1-5, 2018. Data from programs in
small molecules, immunotherapies, biomarker-driven medicines, as well as
biosimilars, will be featured in more than 40 abstracts, including
company-sponsored and collaborative research studies.
“The breadth and depth of our data at ASCO this year are indicative of
our focus on understanding the full potential of our medicines,
including IBRANCE® and XTANDI®, which are already
making a difference in patient lives. We are also exploring new and
exciting pathways designed to transform treatment outcomes,” said
Charles Hugh-Jones, MD, FRCP, chief medical officer, Pfizer Oncology.
“Our comprehensive research is resulting in near-term potential benefits
for patients, as well as multiple new therapies that we hope to
introduce this year.”
The research to be presented includes new insights on Pfizer’s
late-phase investigational compounds dacomitinib, lorlatinib,
talazoparib and glasdegib, as well as Pfizer’s marketed therapy XTANDI®
(enzalutamide). These compounds represent the next five potential Pfizer
Oncology advancements in lung, breast, hematologic and prostate cancers.
“At this year’s ASCO, we’re particularly excited to present overall
survival data for dacomitinib that builds upon our precision medicine
focus and legacy in lung cancer,” said Mace Rothenberg, MD, chief
development officer, Oncology, Pfizer Global Product Development.
“Further, we’ll be sharing new insights on our medicines across 16
disease areas and 13 mechanisms of action, including early-phase through
post-approval analyses. Our extensive presence reinforces our commitment
to speeding accessible breakthrough medicines to patients.”
Key Pfizer abstracts include:
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The first presentation of final overall survival results from the
pivotal ARCHER 1050 study of dacomitinib vs. gefitinib in locally
advanced or metastatic non-small cell lung cancer (NSCLC) with
epidermal growth factor receptor (EGFR)-activating mutation
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Phase 2 results from a clinical research collaboration evaluating
IBRANCE® (palbociclib) in combination with cetuximab in
platinum-resistant HPV unrelated recurrent/metastatic head and neck
squamous cell carcinoma
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An analysis of resistance to therapy based on genetic mutations from
the pivotal PALOMA-3 trial of CDK 4/6 inhibitor IBRANCE in combination
with fulvestrant in ER+/HER2- metastatic breast cancer
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Longer-term efficacy and safety results from two registrational
trials: the JAVELIN Merkel 200 study of PD-L1 inhibitor BAVENCIO®
(avelumab) in a rare skin cancer, being developed in collaboration
with Merck KGaA, Darmstadt, Germany and the BFORE trial of BOSULIF®
(bosutinib) vs. imatinib in patients with newly diagnosed chronic
myeloid leukemia
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A comparative clinical study of PF-06439535, a candidate bevacizumab
biosimilar, and reference bevacizumab, in patients with advanced
non-squamous non-small cell lung cancer
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Details for the Pfizer-sponsored oral presentations are below:
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Title/Abstract Number
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Date/Time (CDT)
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Location
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(Abstract 9008)
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Friday, June 1
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Hall D1
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Avelumab (anti-PD-L1) in Combination with Crizotinib or Lorlatinib
in Patients with Previously Treated Advanced NSCLC: Phase 1b Results
from JAVELIN Lung 101
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4:30 PM – 6:00 PM
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Shaw A
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(Abstract 7002)
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Saturday, June 2
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E450
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Bosutinib vs Imatinib for Newly Diagnosed Chronic Myeloid Leukemia
in the BFORE Trial: 24-Month Follow-Up
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3:00 PM – 6:00 PM
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Cortes J
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(Abstract 1001)
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Sunday, June 3
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Hall D2
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Genetic Landscape of Resistance to CDK4/6 Inhibition in Circulating
Tumor DNA (ctDNA) Analysis of the PALOMA3 Trial of Palbociclib and
Fulvestrant Versus Placebo and Fulvestrant
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8:00 AM – 11:00 AM
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Turner N
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(Abstract 6008)
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Sunday, June 3
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E451
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Multicenter Phase 2 Trial of Palbociclib, a Selective Cyclin
Dependent Kinase (CDK) 4/6 Inhibitor, and Cetuximab in
Platinum-Resistant HPV Unrelated (-) Recurrent/Metastatic Head and
Neck Squamous Cell Carcinoma (RM HNSCC)
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8:00 AM – 11:00 AM
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Adkins D
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(Abstract 9507)
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Monday, June 4
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Arie Crown Theater
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Two-Year Efficacy and Safety Update from JAVELIN Merkel 200 Part A:
A Registrational Study of Avelumab in Metastatic Merkel Cell
Carcinoma Progressed on Chemotherapy
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8:00 AM – 11:00 AM
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Nghiem P
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(Abstract 109)
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Monday, June 4
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Hall D1
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A Comparative Clinical Study of PF-06439535, a Candidate Bevacizumab
Biosimilar, and Reference Bevacizumab, in Patients with Advanced
Non-Squamous Non-Small Cell Lung Cancer
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9:45 AM – 11:15 AM
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Socinski M
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(Abstract 9004)
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Monday, June 4
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Hall B1
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Dacomitinib (daco) Versus Gefitinib (gef) for First-Line Treatment
of Advanced NSCLC (ARCHER 1050): Final Overall Survival (OS) Analysis
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3:00 PM – 6:00 PM
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Mok T
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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/files/news/asco/Pfizer-Oncology-Data-Presentations-ASCO-2018.pdf.
Learn more about how developing new medicines and supporting people with
cancer is personal for Pfizer Oncology at http://www.pfizer.com/research/therapeutic_areas/oncology.
Dacomitinib, lorlatinib, talazoparib and glasdegib are investigational
agents and have not been approved by any regulatory agencies.
Please see full Prescribing Information for BAVENCIO®
(avelumab) at www.Bavencio.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 XTANDI®
(enzalutamide) at www.Xtandi.com.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have
a meaningful impact on people living with cancer. Our growing pipeline
of biologics, small molecules, and immunotherapies is focused on
identifying and translating the best scientific breakthroughs into
clinical application for patients across a diverse array of solid tumors
and hematologic cancers. Today, we have 10 approved oncology medicines
and 14 assets currently in clinical development. By maximizing our
internal scientific resources and collaborating with other companies,
government and academic institutions, as well as patients and non-profit
and professional organizations, we are bringing together the brightest
and most enterprising minds to take on the toughest cancers. Together we
can accelerate breakthrough treatments to patients around the world and
work to redefine life with cancer.
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_News,
LinkedIn,
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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 16, 2018. 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 and investigational oncology portfolio, including,
among others, dacomitinib, lorlatinib, talazoparib, glasdegib 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, 2017 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:
https://www.businesswire.com/news/home/20180516006453/en/
Pfizer Media Contact:
Jessica Smith, 212-733-6213
Jessica.M.Smith@pfizer.com
or
Pfizer
Investor Contact:
Ryan Crowe, 212-733-8160
Ryan.Crowe@pfizer.com
Source: Pfizer Inc.