Bristol-Myers Squibb Announces Collaboration to Evaluate Opdivo (nivolumab) in Combination with Targeted Therapies from Novar...
October 06 2014 - 8:00AM
Business Wire
Studies will evaluate Bristol-Myers Squibb’s
investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab)
in combination with Novartis’ Zykadia (ceritinib), INC280 and
EGF816
Bristol-Myers Squibb Company (NYSE:BMY) announced today the
establishment of a clinical trial collaboration to evaluate the
safety, tolerability and preliminary efficacy of combining
Bristol-Myers Squibb’s investigational PD-1 immune checkpoint
inhibitor Opdivo (nivolumab) with three molecularly targeted
oncology therapies (Zykadia (ceritinib), INC280 and EGF816) from
Novartis (NYSE: NVS). Novartis will conduct two Phase 1/2 studies
focused on non-small cell lung cancer (NSCLC).
“Bristol-Myers Squibb is committed to advancing the science,
research and development of immunotherapy as an innovative approach
to treating cancer in multiple tumor types,” said Michael Giordano,
senior vice president, Oncology Development, Bristol-Myers Squibb.
“Combining Opdivo with select targeted agents from Novartis
complements our broad global development strategy of
immuno-oncology combinations across the spectrum of lung cancer
settings, and supports our goal of improving outcomes for patients.
We look forward to working with Novartis to fully explore how the
combination of these agents can potentially advance care for lung
cancer patients.”
One trial will evaluate the combination of Opdivo with Zykadia
(ceritinib), an FDA-approved treatment for patients with anaplastic
lymphoma kinase-positive (ALK+) metastatic NSCLC who have
progressed on or are intolerant to crizotinib. A second study will
investigate Opdivo with INC280, a potent and highly selective
inhibitor of c-MET receptor tyrosine kinase, and EGF816, a potent,
third-generation EGFR tyrosine kinase inhibitor that is active
against T790 mutations. INC280 and EGF816 are currently being
investigated in various Phase 1/2 NSCLC trials.
Opdivo is part of a new class of cancer treatments known as
immunotherapies designed to harness the body’s own immune system in
fighting cancer, and targets distinct regulatory components of the
immune system. Zykadia, INC280 and EGF816 have each demonstrated
evidence of targeting specific molecules responsible for tumor
growth in NSCLC patient populations. Despite advancements,
treatment for lung cancer remains a significant medical need, and
the studies will explore the potential of enhanced anti-tumor
response using a combined immunotherapy and targeted molecular
approach. Bristol-Myers Squibb has proposed the
name Opdivo (pronounced op-dee-voh), which, if approved
by health authorities, will serve as the trademark for
nivolumab.
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, fully-human
PD-1 immune checkpoint inhibitor that binds to the checkpoint
receptor PD-1 (programmed death-1) expressed on activated
T-cells.
Bristol-Myers Squibb has a broad, global development program to
study Opdivo 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 April 2014, the company initiated a
rolling submission with the FDA for Opdivo in third-line
pre-treated squamous cell NSCLC and expects to complete the
submission by year-end. The FDA granted its first Breakthrough
Therapy Designation for Opdivo in May 2014 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. On September
26, Bristol-Myers Squibb announced that the FDA accepted for
priority review the Biologics License Application (BLA) for
previously treated advanced melanoma, and the Prescription Drug
User Fee Act (PDUFA) goal date for a decision is March 30, 2015.
The FDA also granted Opdivo Breakthrough Therapy status for this
indication. In the European Union, the European Medicines Agency
(EMA) has validated for review the Marketing Authorization
Application (MAA) for Opdivo in advanced melanoma. The application
has also been granted accelerated assessment by the EMA’s Committee
for Medicinal Products for Human Use (CHMP). The EMA also validated
for review the MAA for nivolumab in NSCLC.
Immuno-Oncology at Bristol-Myers Squibb
Surgery, radiation, cytotoxic or targeted therapies have
represented the mainstay of cancer treatment over the last several
decades, but long-term survival and a positive quality of life have
remained elusive for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is
leading advances in the innovative field of immuno-oncology, which
involves agents whose primary mechanism is to work directly with
the body’s immune system to fight cancer. The company is exploring
a variety of compounds and immunotherapeutic approaches for
patients with different types of cancer, including researching the
potential of combining immuno-oncology agents that target different
and complementary pathways in the treatment of cancer.
Bristol-Myers Squibb is committed to advancing the science of
immuno-oncology, with the goal of changing survival expectations
and the way patients live with cancer.
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.
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.
Bristol-Myers SquibbMedia:Ken Dominski,
609-252-5251ken.dominski@bms.comorLaura Hortas,
609-252-4587laura.hortas@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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