-
26-week data from the ongoing 52-week REFLECTIONS B328-06 study met
its primary endpoint, demonstrating comparable safety and efficacy for
patients with indolent follicular lymphoma
-
The U.S. Food and Drug Administration (FDA) accepted for review,
a Biologics License Application (BLA) for PF-05280586 in September 2018
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) announced today at the American Society of
Hematology Annual Meeting that the REFLECTIONS B328-06 study, a
comparative safety and efficacy study of PF-05280586 versus Rituxan®/MabThera®
(rituximab-EU)i, met its primary endpoint of overall response
rate (ORR) at Week 26 of the 52-week study.1
“It is encouraging to see new data supporting a potential rituximab
Biosimilar. If approved this may help provide a more cost-effective
treatment option and expand access for patients and physicians,” said
Dr. Jeff Sharman, medical director, US Oncology Hematology Research.
“The data presented today will help us understand the nuances of the
medicine without the confounding influence of additional concurrent
treatments.”
26-week data from the ongoing 52-week REFLECTIONS B328-06 study (n=394)
demonstrated no clinically meaningful differences in efficacy, in terms
of ORR at Week 26, between PF-05280586 and MabThera, for the first-line
treatment of patients with CD20-positive, low tumor burden, follicular
lymphoma (LTB-FL).1 ORR at Week 26 was 75.5% (PF-05280586) vs
70.7% (rituximab-EU), and was within the pre-specified equivalence
margin. ORR is defined as the percentage of patients achieving complete
response (CR) or partial response (PR), based on central review.
Additionally, estimated rates of one-year progression-free survival were
similar across groups (76.4% vs. 81.2% in the PF-05280586 and MabThera
groups, respectively).1 The results also show that
PF-05280586 had a similar safety profile to MabThera.1
“With a patient centered approach and over a decade of experience
globally,2 Pfizer remains dedicated to developing and
delivering high quality biosimilars with similar efficacy and safety
profiles to originator medicines that help have a meaningful impact on
people living with various conditions including cancer,” said Joe
McClellan, vice president, Biosimilars Development at Pfizer. “We have
also been a committed global partner to the oncology community for
almost 20 years, and the continued growth of our oncology and supportive
care presence, through both novel therapies and biosimilars, means we
are able to provide patients, physicians and healthcare systems with a
wider range of treatment options.”
PF-05280586 has been accepted for review by the FDA, the BsUFA goal date
for a decision by the FDA is in second-quarter 2019. Pfizer is also
working towards making PF-05280586 available for patients in Europe.
Further results on the safety and efficacy from this ongoing 52-week
study in LTB-FL are expected to be presented next year.
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 lymphoma; CD20-positive chronic lymphocytic leukemia;
rheumatoid arthritis; granulomatosis with polyangiitis and microscopic
polyangiitis; and other region-specific indications.3, 4
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 the REFLECTIONS B328-06 Study
REFLECTIONS B328-06 is a randomized, 52-week double-blind clinical trial
evaluating the efficacy, safety and immunogenicity, pharmacokinetics and
pharmodynamics of PF-05280586 versus MabThera for the first-line
treatment of patients with CD20-positive, low tumor burden, follicular
lymphoma.
More information about the PF-05280586 REFLECTIONS B32806 study can be
found at www.clinicaltrials.gov.
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
or follow us on Twitter at @Pfizer
and @Pfizer_News,
LinkedIn,
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and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of
December 2, 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 a product
candidate, PF-05280586, 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 clinical 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; the risk that clinical
trial data are subject to differing interpretations, and, even when we
view data as sufficient to support the safety and/or effectiveness of a
product candidate, regulatory authorities may not share our views and
may require additional data or may deny approval altogether; whether
regulatory authorities will be satisfied with the design of and results
from our clinical studies; whether and when new drug applications may be
filed in any jurisdictions for PF-05280586; whether and when any such
applications may be approved by regulatory authorities, 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 will
be commercially successful; decisions by regulatory authorities
regarding labeling and other matters that could affect the availability
or commercial potential of PF-05280586; 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, 2017 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
.
________________________________
i 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.
1 Sharman, J et
al. A Randomized, Double-Blind Efficacy and Safety Study of PF-05280586
(a Potential Rituximab Biosimilar) Compared with Rituximab Reference
Product (MabThera®) in Subjects with Previously Untreated CD20-Positive,
Low Tumor Burden Follicular Lymphoma (LTB-FL). ASH 2018. Available at https://ash.confex.com/ash/2018/webprogram/Paper111248.html.
Accessed November 2018.
2 EMA Product Information for
RETACRIT. Available at: https://www.ema.europa.eu/medicines/human/EPAR/retacrit.
Accessed November 2018.
3 FDA Prescribing Information
for RITUXAN. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf.
Accessed November 2018.
4 EMA Product Information for
MABTHERA. Available at: https://www.ema.europa.eu/medicines/human/EPAR/mabthera#product-information-section.
Accessed November 2018.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20181202005033/en/
Media:
Thomas Biegi
M: +1 212-733-2204
E: Thomas.Biegi@pfizer.com
Investors:
Ryan Crowe
O: +1 212-733-8160
E: Ryan.Crowe@pfizer.com
Source: Pfizer Inc.