Results demonstrate equivalence in objective response rate in
patients with advanced non-squamous non-small cell lung cancer
NEW YORK--(BUSINESS WIRE)--
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
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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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Source: Pfizer Inc.