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.
Copyright Business Wire 2014