Pfizer Presents Positive 26-Week Data For PF-05280586, A Potential Biosimilar To Rituximab, At The American Society Of Hemato...
02 Décembre 2018 - 09:45PM
Business Wire
- 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
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, YouTube
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.
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Media:Thomas BiegiM: +1 212-733-2204E:
Thomas.Biegi@pfizer.com
Investors:Ryan CroweO: +1 212-733-8160E:
Ryan.Crowe@pfizer.com
Pfizer (NYSE:PFE)
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