Full data from the Phase 3 CROWN study in lung
cancer will be presented during the Presidential Symposium
Pfizer Inc. (NYSE:PFE) announced today that more than 50
abstracts representing data from nine approved and investigational
Pfizer medicines, including several biomarker-driven and
immuno-therapies, will be presented at the European Society for
Medical Oncology (ESMO) Virtual Congress 2020 being held from
September 19-21, 2020. Data to be presented include findings from
the Phase 3 CROWN study of LORBRENA® (lorlatinib)* in first-line
ALK-positive non-small cell lung cancer (NSCLC), building on
Pfizer’s extensive heritage in precision medicine research.
In addition to the CROWN study, several biomarker analyses that
provide further insights on Pfizer medicines across a range of
cancers will be presented, including BAVENCIO® (avelumab),
BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib), and IBRANCE®
(palbociclib). BAVENCIO is being developed and commercialized in
collaboration with Merck KGaA, Darmstadt, Germany.
“Meaningful innovation in cancer care requires building upon our
understanding of tumor biology, leveraging cutting-edge research,
and applying the knowledge we gain into new treatments that address
and prevent resistance,” said Chris Boshoff, M.D., Ph.D., Chief
Development Officer, Oncology, Pfizer Global Product Development.
“We are proud to share the latest insights on our cancer medicines
at ESMO this year, including data from the CROWN trial examining
the first-line use of our third-generation biomarker-driven therapy
in ALK-positive non-small cell lung cancer.”
Pfizer will also continue its commitment to help non-scientists
understand the latest findings with the development of abstract
plain language summaries (APLS) for company-sponsored research
being presented at ESMO, which are written in non-technical
language. Those interested in learning more can visit
www.Pfizer.com/apls to access the summaries starting September
18.
Key presentations featuring Pfizer medicines at ESMO
include:
Pfizer-Sponsored Studies
Proffered Paper (Presentation
LBA2)
Saturday, September 19, 2020
Lorlatinib vs Crizotinib in the First-line
Treatment of Patients with Advanced ALK-Positive Non-Small Cell
Lung Cancer (NSCLC): Results of the Phase 3 CROWN Study
Solomon B.
Proffered Paper (Presentation
699O)
Saturday, September 19, 2020
Avelumab First-line (1L) Maintenance +
Best Supportive Care (BSC) vs BSC Alone for Advanced Urothelial
Carcinoma (UC): Association between Clinical Outcomes and
Exploratory Biomarkers
Sridhar S.
Proffered Paper (Presentation
910O)
Saturday, September 19, 2020
Primary Results of the Phase III JAVELIN
Head & Neck 100 Trial: Avelumab Plus Chemoradiotherapy (CRT)
Followed by Avelumab Maintenance vs CRT in Patients with Locally
Advanced Squamous Cell Carcinoma of the Head and Neck (LA
SCCHN)
Cohen E.
Mini Oral (Presentation 704MO)
Friday, September 18, 2020
Avelumab First-line (1L) Maintenance +
Best Supportive Care (BSC) vs BSC Alone with 1L Chemotherapy (CTx)
for Advanced Urothelial Carcinoma (UC): Subgroup Analyses from
JAVELIN Bladder 100
Grivas P.
Investigator-Sponsored Studies and
Clinical Research Collaborations
Proffered Paper (Presentation
LBA12)
Sunday, September 20, 2020
PALLAS: A Randomized Phase III Trial of
Adjuvant Palbociclib with Endocrine Therapy Versus Endocrine
Therapy Alone for HR+/HER2- Early Breast Cancer
Mayer E.
Proffered Paper (Presentation
LBA45)
Saturday, September 19, 2020
First Report of Efficacy and Safety from
the Phase II Study SECOMBIT (SEquential COMBo Immuno and Targeted
Therapy Study)
Ascierto P.
Mini Oral (Presentation LBA27)
Friday, September 18, 2020
Phase II Multicenter, Randomized Study to
Evaluate Efficacy and Safety of Avelumab with
Gemcitabine/Carboplatin (CG) vs CG Alone in Patients with
Unresectable or Metastatic Urothelial Carcinoma (mUC) Who Are
Ineligible to Receive Cisplatin-based Therapy
Pérez Valderrama B.
Presentations will be available to registered attendees during
the Congress at www.ESMO.org. A complete list of Pfizer-sponsored
abstracts will be available at
http://www.pfizer.com/news/press-kits/oncology.
Merck KGaA, Darmstadt, Germany and Pfizer have a global
strategic alliance to jointly develop and commercialize
BAVENCIO.
*LORBRENA (lorlatinib) is available in the European Union under
the brand name LORVIQUA®.
Prescribing Information for Pfizer Medicines
- Please see full US Prescribing Information and Medication Guide
for BAVENCIO® (avelumab) available at www.Bavencio.com.
- Please see full Prescribing Information for BRAFTOVI®
(encorafenib) + MEKTOVI®(binimetinib) available at
www.BraftoviMektovi.com.
- Please see full Prescribing Information for IBRANCE®
(palbociclib) at www.Ibrance.com.
- Please see full Prescribing Information for LORBRENA®
(lorlatinib) at www.Lorbrena.com.
- Please see full Prescribing Information for XALKORI®
(crizotinib) at www.Xalkori.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 people living with cancer. Today, we have an
industry-leading portfolio of 23 approved innovative cancer
medicines and biosimilars across more than 30 indications,
including breast, genitourinary, colorectal, blood and lung
cancers, as well as 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 September 10, 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
Oncology’s approved and investigational portfolio, including, among
others, LORBRENA (lorlatinib), BAVENCIO® (avelumab), BRAFTOVI®
(encorafenib) + MEKTOVI® (binimetinib) and IBRANCE® (palbociclib),
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, 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; risks associated with interim
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 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 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 oncology 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; uncertainties regarding
the impact of COVID-19 on Pfizer’s 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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version on businesswire.com: https://www.businesswire.com/news/home/20200910005199/en/
Pfizer Media Contacts: Jessica Smith (U.S.) (212) 733-6213
Jessica.M.Smith@pfizer.com
Dervila Keane (EU) (353) 86 2110834 Dervila.Keane@Pfizer.com
Pfizer Investor Contact: Ryan Crowe (212) 733-8160
Ryan.Crowe@pfizer.com
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