Phase 3 First-Line Melanoma Study of Nivolumab, an Investigational PD-1 Checkpoint Inhibitor, Demonstrates Superior Overall S...
June 24 2014 - 4:45PM
Business Wire
Bristol-Myers Squibb Company (NYSE:BMY) today announced that a
randomized blinded comparative Phase 3 study evaluating nivolumab
versus dacarbazine (DTIC) in patients with previously untreated
BRAF wild-type advanced melanoma was stopped early because an
analysis conducted by the independent Data Monitoring Committee
(DMC) showed evidence of superior overall survival in patients
receiving nivolumab compared to the control arm. Patients in the
trial will be unblinded and allowed to cross over to nivolumab. The
Company will share these data with health authorities.
“The outcome of CheckMate -066 is an important milestone in the
field of immuno-oncology as it represents the first
well-controlled, randomized Phase 3 trial of an investigational
PD-1 checkpoint inhibitor to demonstrate an overall survival
benefit,” said Michael Giordano, MD, Head of Oncology Development.
“Bristol-Myers Squibb is committed to continuing to lead advances
in immuno-oncology and to executing our strategy to provide
patients with the best opportunity to achieve the potential for
long term survival.”
CheckMate -066 investigators have been informed of the decision
to stop the blinded comparative portion of the trial. Bristol-Myers
Squibb will ensure that patients are informed of the opportunity to
continue or start treatment with nivolumab in an open-label
extension as part of the Company’s commitment to characterize
long-term survival. The study, which was designed in consultation
with the Committee for Medicinal Products for Human Use (CHMP), was
primarily conducted in countries where DTIC is a commonly-used
treatment in the first-line setting, including Canada, but not at
U.S. trial sites. The Company will complete a full evaluation of
the final CheckMate -066 data and work with investigators on the
future presentation and publication of the results.
About the Study
CheckMate -066 is a Phase 3 randomized, double-blind study of
patients with previously untreated BRAF wild-type unresectable
Stage III and IV melanoma. The trial enrolled 418 patients who were
randomized to receive either nivolumab 3 mg/kg every two weeks or
DTIC 1000 mg/m2 every three weeks. The primary endpoint was overall
survival. Secondary endpoints included progression free survival
and objective response rate.
About Nivolumab
Cancer cells may exploit “regulatory” pathways, such as
checkpoint pathways, to hide from the immune system and shield the
tumor from immune attack. Nivolumab 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. We are investigating whether by blocking this
pathway, nivolumab would enable the immune system to resume its
ability to recognize, attack and destroy cancer cells.
Bristol-Myers Squibb has a broad, global development program to
study nivolumab 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 non-small
cell lung cancer melanoma, renal cell carcinoma (RCC), head and
neck cancer, glioblastoma and non-Hodgkin lymphoma. In 2013, the
FDA granted Fast Track designation for nivolumab in NSCLC, melanoma
and RCC. In May 2014, the FDA granted nivolumab Breakthrough
Therapy Designation for the treatment of patients with Hodgkin
lymphoma after failure of autologous stem cell transplant and
brentuximab.
About Advanced Melanoma
Melanoma is a form of skin cancer characterized by the
uncontrolled growth of pigment-producing cells (melanocytes)
located in the skin. Metastatic melanoma is the deadliest form of
the disease, and occurs when cancer spreads beyond the surface of
the skin to other organs, such as the lymph nodes, lungs, brain or
other areas of the body. The incidence of melanoma has been
increasing for at least 30 years. In 2012, an estimated 232,130
melanoma cases were diagnosed globally. Melanoma is mostly curable
when treated in its early stages. However, in its late stages, the
average survival rate has historically been just six months with a
one-year mortality rate of 75%, making it one of the most
aggressive forms of cancer.
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 a rapidly evolving field of cancer research and
treatment known as 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 the Bristol-Myers Squibb and Ono
Pharmaceutical Partnership
Through a collaboration agreement with Ono Pharmaceutical in
2011, Bristol-Myers Squibb expanded its territorial rights to
develop and commercialize nivolumab (BMS-936558/ONO-4538) globally
except in Japan, Korea and Taiwan where Ono has retained all rights
to the compound.
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 about Bristol-Myers Squibb, 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 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:Sarah Koenig,
609-252-4145sarah.koenig@bms.comorInvestors:Ranya Dajani,
609-252-5330,ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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