- In CheckMate -063, the objective
response rate was 15% in patients treated with single agent Opdivo
and median duration of response was not reached
- 41% of Opdivo-treated patients were
alive at one year
- Types and frequency of
treatment-related adverse events were consistent with early
clinical experience and managed using recommended treatment
algorithms
- Rolling submission initiated with
FDA in April based on CheckMate 063; company expects to complete
submission by year end
Bristol-Myers Squibb Company (NYSE:BMY) today announced results
from CheckMate -063, a Phase 2 single-arm, open-label study of
Opdivo (nivolumab), an investigational PD-1 immune checkpoint
inhibitor, administered as a single agent in patients with advanced
squamous cell non-small cell lung cancer (NSCLC) who have
progressed after at least two prior systemic treatments with 65%
receiving three or more prior therapies (n=117). With approximately
11 months of minimum follow up, the objective response rate (ORR,
the study’s primary endpoint) was 15% (95% CI = 8.7, 22.2) as
assessed by an independent review committee (IRC) using RECIST 1.1
criteria and the median duration of response was not reached. The
estimated one-year survival rate was 41% (95% CI = 31.6, 49.7) and
median overall survival (mOS) was 8.2 months (95% CI = 6.05,
10.91). These data will be presented during the Plenary Session at
the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology
on October 31 (Abstract #3462).
“The Phase 2 findings from CheckMate -063 are encouraging as
there are no effective treatment options for patients with
refractory squamous cell lung cancer after their disease has
progressed through two prior therapies,” said Suresh S. Ramalingam,
MD, Professor and Director of Medical Oncology, Winship Cancer
Institute of Emory University. “The results are also consistent
with Phase 1 data previously reported from Study -003.”
Historically, the expected one-year survival rate for third-line
squamous cell NSCLC patients is approximately 5.5% - 18%.1,2
Grade 3-4 drug-related adverse events (AEs) were reported in
17.1% of patients. The most common Grade 3-4 AEs (greater than or
equal to 2%) were fatigue (4.3%), pneumonitis (3.4%), and diarrhea
(2.6%). Discontinuations due to drug-related AEs of any grade
occurred in 12% of patients and there were two drug-related deaths
in patients with multiple comorbidities and in the setting of
progressive disease.
“Results from CheckMate -063 offer further clinical evidence of
the potential of immuno-oncology as an innovative approach to
treating this disease,” said Michael Giordano, senior vice
president, Head of Development, Oncology. “We are committed to
addressing the significant unmet medical needs of patients with
lung cancer and have the broadest development program evaluating
our approved and investigational immuno-oncology agents across
multiple lines of therapy and histology.”
Bristol-Myers Squibb’s lung cancer research and development
program is evaluating its approved and investigational
immunotherapies – either as single agents or as part of combination
regimens – across lines of therapy, histologies and biomarker
expression. Among these are six ongoing Phase 3 trials. Four Phase
3 trials are evaluating Opdivo (nivolumab) as a single agent –
three in previously treated patients (CheckMate -017, CheckMate
-057 and CheckMate -153 ) and one in chemotherapy-naïve patients
(CheckMate -026). Two Phase 3 trials evaluating Yervoy in
combination with chemotherapy in newly diagnosed small cell lung
cancer (Study -156) and squamous cell NSCLC (Study -104) are
ongoing.
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 the Checkmate -063 Trial Design
& Detailed Results
Checkmate -063 is a Phase 2 single arm, open-label study
designed to assess advanced squamous cell NSCLC patients who
progressed after both platinum-based therapy and at least one
additional systemic therapy with an ECOG Performance Status of 0 or
1 who were treated with Opdivo as a single agent 3mg/kg by
intravenous infusion every two weeks until disease progression or
treatment discontinuation (n=117). The primary endpoint was ORR as
assessed by an IRC using RECIST 1.1 criteria. Responders were
further characterized by duration of response. Secondary endpoints
included investigator-assessed ORR. Overall survival, PFS and
efficacy by PD-L1 expression status were exploratory endpoints. All
treated patients had received at least two prior systemic regimens
with 65% receiving greater than or equal to three prior therapies.
Seventy-six percent of patients were within three months of
completion of their most recent therapy. The best response to the
most recent prior systemic therapy was progressive disease in 61%
of patients.
With approximately 11 months of minimum follow up, the ORR was
15% (95% CI = 8.7, 22.2) as assessed by an IRC using RECIST 1.1
criteria and the median duration of response was not reached. The
estimated one-year survival rate was 41% (95% CI = 31.6, 49.7) and
mOS was 8.2 months (95% CI = 6.05, 10.91). An additional 26% of
patients had stable disease with a median duration of six months
(95% CI, 4.73, 10.91) giving a disease control rate (defined as
partial response + stable disease) of 41%. For patients with
quantifiable PD-L1 expression, responses were observed independent
of PD-L1 status.
Grade 3-4 drug-related AEs were reported in 17.1% of patients.
The most common (greater than or equal to 2%) Grade 3-4 AEs were
fatigue (4.3%), pneumonitis (3.4%), and diarrhea (2.6%).
Drug-related AEs generally were manageable with corticosteroids
and/or supportive care as per established safety algorithms.
Discontinuations due to drug-related AEs of any grade occurred in
12% of patients and there were two drug-related deaths in patients
with muliple comorbidities and in the setting of progressive
disease.
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 based on CheckMate -063 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 Biologics License Application 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 and lung cancer. The advanced melanoma
application has also been granted accelerated assessment by the
EMA’s Committee for Medicinal Products for Human Use (CHMP).
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally,
resulting in more than 1.5 million deaths each year according the
World Health Organization. NSCLC is one of the most common types of
the disease and accounts for approximately 85 percent of cases.
Survival rates vary depending on the stage and type of the cancer
when it is diagnosed. Globally, the five-year survival rate for
Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC, the
five-year survival rate drops to two percent. Historically, the
expected one-year survival rate for third-line squamous cell NSCLC
patients is approximately 5.5% - 18%.i, ii
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 Co., 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
regimens – 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.
1 Massarelli E, et al. Lung Cancer 2003;39: 55-61
2 Penrod JR, et al. Poster presentation at ASCO 2014. Poster
45
Bristol-Myers SquibbMedia: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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