- Objective response rate was 32% in
Opdivo treated patients and 11% in the reference arm of
chemotherapy-treated patients
- Majority (95%) of responses were
ongoing in Opdivo treated patients and median duration of response
was not reached
- Overall frequency of adverse events
was lower with Opdivo compared to chemotherapy; Opdivo
treatment-related adverse events were managed using recommended
treatment algorithms
Bristol-Myers Squibb Company (NYSE:BMY) today announced positive
results from CheckMate -037, a Phase 3 randomized, controlled
open-label study of Opdivo (nivolumab), an investigational PD-1
immune checkpoint inhibitor, versus investigator’s choice
chemotherapy (ICC) in patients with advanced melanoma who were
previously treated with Yervoy (ipilimumab). Based on a planned
interim analysis of the co-primary endpoint, the objective response
rate (ORR) was 32% (95% CI = 24, 41) in the Opdivo arm (n=120) and
11% (95% CI = 4, 23) in the ICC reference arm (n=47) in patients
with at least six months of follow up. The majority (95%) of
responses were ongoing in the Opdivo arm and the median duration of
response was not reached. ORR was based on RECIST criteria as
evaluated by an independent radiologic review committee (IRRC).
These data were highlighted at a ESMO 2014 Congress press briefing
today in Madrid and will be presented during the Presidential
Symposium at 4 p.m. CEST (Abstract #LBA3_PR).
“These data are important as they mark the first presentation of
results from a Phase 3 randomized study for the PD-1 immune
checkpoint inhibitor class,” said Jeffrey S. Weber, MD, Ph.D.,
director of the Donald A. Adam Comprehensive Melanoma Research
Center at Moffitt Cancer Center. “Additionally, the response rate
and duration of response in patients treated with Opdivo are
consistent with findings from the early Phase 1 trial in previously
treated advanced melanoma (Study -003).”
Safety was reported on all patients treated in the Opdivo
(n=268) and ICC (n=102) arms. The majority of Opdivo
treatment-related adverse events (AEs) were Grade 1/2 and managed
using recommended treatment algorithms. Grade 3/4 drug-related AEs
were less frequent for the Opdivo arm (9% versus 31% of patients
treated chemotherapy). Serious Grade 3/4 drug-related AEs were
reported in 5% and 9% of patients treated with Opdivo and ICC,
respectively. There was no Grade 3/4 pneumonitis (inflammatory lung
disease) with Opdivo. Discontinuations due to drug-related AEs, of
any grade, occurred in 2% of Opdivo-treated patients and 8% of
patients administered ICC. There were no deaths related to study
drug toxicity.
“This second set of positive Phase 3 data for Opdivo in patients
with advanced melanoma supports a deeper understanding of the
potential of immuno-oncology in this disease,” said Michael
Giordano, M.D., senior vice president, Head of Development,
Oncology. “These results confirm our belief in the potential of
immuno-oncology, and our broad development program continues to
evaluate Opdivo in advanced melanoma across lines of therapy, both
as a single agent and as part of a combination regimen.”
In June, Bristol-Myers Squibb announced that a randomized
blinded comparative Phase 3 study evaluating Opdivo versus
dacarbazine in patients with previously untreated BRAF wild-type
advanced melanoma (CheckMate -066) was stopped early because an
analysis conducted by the independent Data Monitoring Committee
showed evidence of superior overall survival in patients receiving
Opdivo compared to the control arm. The Company is working with
investigators on the future presentation and publication of the
results from CheckMate -066.
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.
About CheckMate 037
CheckMate -037 is a Phase 3 randomized, open-label study (n=370)
designed to estimate the ORR in the Opdivo arm and compare the OS
of patients treated with Opdivo versus those patients administered
ICC. Patients in the trial were randomized 2:1 to receive Opdivo 3
mg/kg by intravenous infusion every two weeks (n=268) or ICC
(dacarbazine 1000 mg/m2 every three weeks or carboplatin (AUC) 6
plus paclitaxel 175 mg/m2 every three weeks; n=102) until
progression or unacceptable toxicity. Patients were classified by
PD-1 ligand expression, BRAF status (wild type or mutated) and best
response to prior treatment with Yervoy. Co-primary endpoints of
the study are ORR and overall survival (OS). Response, as measured
by standard RECIST 1.1 criteria by an IRRC, was assessed nine weeks
after randomization, every six weeks for the first 12 months and
then every 12 weeks. An interim analysis of OS had not taken place
at the time of the ORR analysis.
About Opdivo
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 non-small
cell lung cancer (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
(nivolumab) 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 Opdivo Breakthrough
Therapy Designation 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 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).
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 the 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 percent, 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 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 the Bristol-Myers Squibb and Ono
Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono
Pharmaceutical, Bristol-Myers Squibb expanded its territorial
rights to develop and commercialize Opdivo globally except in
Japan, South Korea and Taiwan, where Ono had retained all rights to
the compound at the time. On July 23, 2014, Bristol-Myers Squibb
and Ono Pharmaceutical further expanded the companies’ strategic
collaboration agreement to jointly develop and commercialize
multiple immunotherapies – as single agents and combination
regiments – for patients with cancer in Japan, South Korea and
Taiwan.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global pharmaceutical 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 Opdivo will receive regulatory approval in the U.S. 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 Squibb CompanyMedia:Sarah Koenig,
609-252-4145sarah.koenig@bms.comorChrissy Trank,
609-252-3418Christina.trank@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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