Results from the Comparative REFLECTIONS B3281006 Study
Demonstrate Equivalence in Patients with Indolent Follicular Lymphoma
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) today announced that REFLECTIONS B3281006, a
comparative safety and efficacy study of PF-05280586 versus MabThera®
(rituximab-EU), met its primary endpoint. PF-05280586 is being developed
by Pfizer as a potential biosimilar to Rituxan®
(rituximab-US)/MabThera®1.
The trial demonstrated equivalence in overall response rate (ORR) for
the first-line treatment of patients with CD20-positive, low tumor
burden, follicular lymphoma.
“We are pleased to report on our fifth proposed biosimilar monoclonal
antibody (mAb) with positive study results. These results reinforce the
potential of our proposed rituximab biosimilar in providing a safe and
effective treatment option for patients,” said Amrit Ray, MD, Global
President, Pfizer Essential Health Research and Development. “As a
global leader in novel biologics, and with one of the broadest global
portfolios in oncology, we are delivering on our commitment to advancing
high-quality medicines for the millions of patients with cancer around
the world today and in the future.”
Pfizer’s biosimilars pipeline consists of seven distinct biosimilar
molecules in mid to late stage development, with three of these in
oncology, as well as several others in early stage development.
About the REFLECTIONS B3281006 Study
REFLECTIONS B3281006 is a randomized, double-blind clinical trial
evaluating the efficacy, safety, pharmacokinetics and immunogenicity of
PF-05280586 versus MabThera® (rituximab-EU)for the first-line
treatment of patients with cd20-positive, low tumor burden, follicular
lymphoma. The primary endpoint measure, ORR, is defined according to the
revised response criteria for malignant lymphoma [Time Frame: Week 26].
Results of the study will be presented in full at a future medical
meeting or summarized in publication.
More information about the PF-05280586 REFLECTIONS B3281006 study can be
found at www.clinicaltrials.gov.
About PF-05280586
PF-05280586 is a monoclonal antibody (mAb) that is in development as a
potential biosimilar to Rituxan®/MabThera®. Rituxan®/MabThera®
is indicated for the treatment of patients with certain types of
CD20-positive non-Hodgkin’s lymphoma; CD20-positive chronic lymphocytic
leukemia; rheumatoid arthritis; granulomatosis with Polyangiitis and
Microscopic Polyangiitis; and other region-specific indications.
PF-05280586 is an investigational compound and has not received
regulatory approval in any country. Biosimilarity has not yet been
established by regulatory authorities.
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
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DISCLOSURE NOTICE: The information contained in this release is as of
January 24, 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 PF-05280586
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-05280586 or any other
biosimilars in development may be filed with regulatory authorities in
any jurisdictions; whether and when regulatory authorities in any
jurisdictions may approve any such applications, 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 PF-05280586 or any such other
biosimilars in development will be commercially successful; 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-05280586 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 Rituximab is marketed in the U.S. under the brand name
Rituxan® and marketed in the E.U. and other regions under the
brand name MabThera®. Rituxan® and MabThera®
are registered trademarks of Genentech, Inc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180124005631/en/
Source: Pfizer Inc.