Results Demonstrate Equivalence in Objective Response Rate in
Patients with HER2-positive Metastatic Breast Cancer
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the pivotal REFLECTIONS
B3271002 study, a comparative safety and efficacy study of PF-05280014
versus Herceptin® (trastuzumab), met its primary endpoint. PF-05280014
is being developed by Pfizer as a potential biosimilar to Herceptin.
“Forward-Looking Information and Factors That May Affect Future
The trial demonstrated equivalence in the primary endpoint of objective
response rate (ORR) of PF-05280014 versus Herceptin, taken in
combination with paclitaxel, in first line patients with HER2-positive
metastatic breast cancer. ORR is defined as the proportion of patients
with tumor size reduction of a predefined amount and for a minimum
period of time2.
“As the leading global biosimilars company, we are committed to
advancing our robust pipeline of biosimilar therapies in hopes of
expanding access to high-quality treatment options for patients living
with serious, life-threatening conditions such as cancer,” said Sumant
Ramachandra, MD, PhD, MBA, Head of Research and Development, Pfizer
Essential Health. “Favorable comparative clinical data between proposed
biosimilars and their respective reference product contribute to
physician and patient understanding of and confidence in the value and
importance of biosimilars. We are encouraged by these data and look
forward to sharing the complete results with health authorities and the
oncology community once available.”
A separate comparative, randomized, double-blind clinical trial
[REFLECTIONS B3271004] in early breast cancer patients [N=226] also met
its primary endpoint of steady-state Ctrough concentrations
(PK) in patients treated with PF-05280014 and Herceptin.
About the REFLECTIONS B3271002 Study
REFLECTIONS B3271002 is a comparative, randomized, double blind,
clinical trial[N=690] evaluating the efficacy, safety, pharmacokinetics
(PK) and immunogenicity of PF-05280014 (a potential biosimilar to
Herceptin® [trastuzumab]) in combination with paclitaxel versus
Herceptin in combination with paclitaxel in first line patients with
HER2-positive metastatic breast cancer. The primary endpoint is
objective response rate (ORR) by Week 25 of study treatment. ORR is
defined as the proportion of patients with tumor size reduction of a
predefined amount and for a minimum period of time2.
More information about the PF-05280014 REFLECTIONS B3271002 and B3271004
studies can be found at www.clinicaltrials.gov.
PF-05280014 is a monoclonal antibody (mAb) that is in development as a
potential biosimilar for all currently approved indications of
Herceptin is currently approved in the U.S., EU and other markets for
HER2-positive breast cancer and gastric cancer.
PF-05280014 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
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DISCLOSURE NOTICE: The information contained in this release is as of
November 30, 2016. 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-05280014,
including its 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-05280014 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-05280014, 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-05280014; and competitive
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, 2015, 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
1 Herceptin® is a registered US trademark of Genentech, Inc.
2 United States Food and Drug Administration. Guidance for
Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and
Biologics. Available at: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071590.pdf.
Accessed October 27, 2016.