Phase I study to evaluate OPDIVO
(nivolumab), Bristol-Myers Squibb’s investigational PD-1 immune
checkpoint inhibitor, with Celgene’s ABRAXANE® for
multiple cancers
Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation
(Nasdaq:CELG) announced today the establishment of a clinical trial
collaboration to evaluate the safety, tolerability and preliminary
efficacy of a combination regimen of Bristol-Myers Squibb’s
investigational PD-1 immune checkpoint inhibitor, OPDIVO
(nivolumab), and Celgene’s nab® technology-based chemotherapy
ABRAXANE® (paclitaxel protein-bound particles for injectable
suspension) (albumin-bound), in a Phase I study. Multiple tumor
types will be explored in the study including HER-2 negative
metastatic breast cancer, pancreatic cancer and non-small cell lung
cancer (NSCLC). The proprietary name OPDIVO has been proposed in
the U.S. and other countries, but remains subject to health
authority approval.
OPDIVO is part of a new class of cancer treatments known as
immunotherapies that are designed to harness the body’s own immune
system in fighting cancer. OPDIVO targets distinct regulatory
components of the immune system, while ABRAXANE works by
interfering with the ability of cancer cells to divide. By
combining an immunotherapy with a standard chemotherapy, the
companies will explore whether these two agents may lead to an
enhanced anti-tumor response compared to either agent alone.
“Bristol-Myers Squibb continues to forge partnerships focused on
exploring the effects of combination regimens that utilize
promising therapies from our immuno-oncology portfolio,” said
Michael Giordano, senior vice president, Oncology Development,
Bristol-Myers Squibb. “Through this collaboration, Bristol-Myers
Squibb and Celgene will work together to advance the science and
understanding of how the body’s own immune system and chemotherapy
might work together to fight cancer.”
“Our collaboration with Bristol-Myers Squibb further underscores
our commitment to understanding and modulating the immune system to
advance the treatment paradigm in cancer,” said Markus Renschler,
MD, Senior Vice President, Global Head of Hematology & Oncology
Medical Affairs, Celgene. “We believe that ABRAXANE is appropriate
as a combination partner for novel immuno-oncology therapies due to
its proven anti-tumor activity and that it can be administered
without steroid premedication.”
The study, which is expected to begin in the fourth quarter of
2014, will be conducted by Celgene. Patients with HER-2 negative
breast cancer will be treated with ABRAXANE and OPDIVO, patients
with NSCLC will be treated with the combination of ABRAXANE,
carboplatin and OPDIVO, and patients with pancreatic adenocarcinoma
will be treated with ABRAXANE, gemcitabine and OPDIVO. Additional
details of the collaboration were not disclosed.
About OPDIVO (nivolumab)
Cancer cells may exploit “regulatory” pathways, such as
checkpoint pathways, to hide from the immune system and shield the
tumor from immune attack. OPDIVO is an investigational human PD-1
immune checkpoint inhibitor that binds to the checkpoint receptor
PD-1 (programmed death-1) expressed on activated T-cells. The
company is investigating whether by blocking this pathway, OPDIVO
would enable the immune system to resume its ability to recognize,
attack and destroy cancer cells.
OPDIVO was approved in Japan on July 4, 2014 for the treatment
of patients with unresectable melanoma and is studied in multiple
tumor types consisting of more than 35 trials – as monotherapy or
in combination with other therapies – in which more than 7,000
patients have been enrolled worldwide. Among these are several
potentially registrational trials in NSCLC, melanoma, renal cell
carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin
lymphoma. In 2013, the FDA granted Fast Track designation for
OPDIVO in NSCLC, melanoma and RCC. In May 2014, the FDA granted
OPDIVO Breakthrough Therapy Designation for the treatment of
patients with Hodgkin lymphoma after failure of autologous stem
cell transplant and brentuximab. On July 4, Ono Pharmaceutical
Co. announced that OPDIVO received manufacturing and marketing
approval in Japan for the treatment of patients with unresectable
melanoma, making OPDIVO the first PD-1 immune checkpoint inhibitor
to receive regulatory approval anywhere in the world.
About ABRAXANE®
ABRAXANE is an albumin-bound form of paclitaxel that is
manufactured using patented nab® technology.
ABRAXANE is formulated with albumin, a human protein, and is free
of solvents.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit www.bms.com or follow us on Twitter at
http://twitter.com/bmsnews.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey,
is an integrated global biopharmaceutical company engaged primarily
in the discovery, development and commercialization of novel
therapies for the treatment of cancer and inflammatory diseases
through gene and protein regulation. For more information, please
visit www.celgene.com. Follow us on Twitter @Celgene as
well.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that nivolumab will receive regulatory approval in the U.S. either
as a single agent or in a combination regimen, or, if approved,
that it will become a commercially successful product.
Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect
Bristol-Myers Squibb's business, particularly those identified in
the cautionary factors discussion in Bristol-Myers Squibb's Annual
Report on Form 10-K for the year ended December 31, 2013 in our
Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events or otherwise.
Celgene Forward-Looking Statement
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking
statements are based on management's current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual
Report on Form 10-K and our other reports filed with
the Securities and Exchange Commission.
Bristol-Myers SquibbMedia:Laura Hortas,
609-252-4587laura.hortas@bms.comKen Dominski,
609-252-5251ken.dominski@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comRyan Asay,
609-252-5020ryan.asay@bms.comorCelgeneInvestors:908-673-9628investors@celgene.comorMedia:908-673-2275media@celgene.com
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