Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B7391003 Study for PF-06439535, a Potential Biosi...
July 24 2017 - 7:30AM
Business Wire
Results demonstrate equivalence in objective
response rate in patients with advanced non-squamous non-small cell
lung cancer
Pfizer Inc. (NYSE:PFE) today announced that the REFLECTIONS
B7391003 study, a comparative, confirmatory safety and efficacy
study of PF-06439535 versus Avastin® (bevacizumab), met its primary
objective. PF-06439535 is being developed by Pfizer as a potential
biosimilar to Avastin.
The trial demonstrated equivalence in the primary endpoint of
objective response rate (ORR) of PF-06439535 versus Avastin, taken
in combination with carboplatin/paclitaxel, for the first line
treatment of patients with advanced non-squamous non-small cell
lung cancer (NSCLC).
“We are encouraged by this data, and its importance in helping
to advance physician confidence in, and understanding of, the
potential value of biosimilar medicines for cancer patients around
the world,” said Salomon Azoulay, MD, Senior Vice President, Chief
Medical Officer, Pfizer Essential Health. “As Pfizer’s second
proposed oncology monoclonal antibody biosimilar to achieve
positive top line data results, we continue to focus on and commit
to advancing our pipeline of proposed biosimilars, with the goal of
expanding patient access to these important therapeutic
options.”
This latest data announcement represents Pfizer’s second
proposed oncology biosimilar and the fourth proposed biosimilar
pipeline molecule to report positive top-line results within the
past year. The Pfizer biosimilars pipeline consists of eight
distinct biosimilar molecules in mid to late stage development, and
several others in early stage development.
About the REFLECTIONS B7391003 Study
REFLECTIONS B7391003 is a comparative, randomized, double blind,
clinical trial [N=719] evaluating the efficacy, safety,
pharmacokinetics (PK) and immunogenicity of PF-06439535 (a
potential biosimilar to Avastin® [bevacizumab]) in combination with
carboplatin/paclitaxel versus Avastin in combination with
carboplatin/paclitaxel for the first line treatment of patients
with advanced non-squamous non-small cell lung cancer (NSCLC). The
primary endpoint is objective response rate (ORR) which is defined
as the proportion of patients with tumor size reduction of a
predefined amount and for a minimum period of time.
More information about the PF-06439535 REFLECTIONS B7391003
study studies can be found at www.clinicaltrials.gov.
About PF-06439535
PF-06439535 is a monoclonal antibody (mAb) that is in
development as a potential biosimilar to Avastin® (bevacizumab).
Avastin is approved in the U.S., EU and other regions for the
treatment of patients with unresectable, locally advanced,
recurrent or metastatic non-squamous lung cancer (NSCLC) in
addition to metastatic carcinoma of the colon or rectum; metastatic
renal cell carcinoma; and other region-specific indications.
PF-06439535 is an investigational compound and has not received
regulatory approval in any country. Biosimilarity has not yet been
established by regulatory authorities and is not yet claimed.
About Pfizer: 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, YouTube
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of July 24, 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
PF-06439535 and Pfizer’s proposed biosimilars pipeline, 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 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; whether and when any
applications for PF-06439535 or any other biosimilars in
development may be filed with regulatory authorities in any
jurisdictions; whether and when regulatory authorities in any such
jurisdictions may approve any such applications for PF-06439535 or
any other biosimilars in development, 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; intellectual property and/or litigation
implications; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of PF-06439535 or any other biosimilars in
development; 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, 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 10-Q and 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.
1 Avastin® is a registered US trademark of Genentech, Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20170724005288/en/
Pfizer Inc.Media:Thomas Biegi, (212)
733-2204Thomas.Biegi@pfizer.comorInvestor:Ryan Crowe, (212)
733-8160Ryan.Crowe@pfizer.com
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