Results support Opdivo Breakthrough Therapy
Designation granted by FDA for the treatment of patients with
Hodgkin Lymphoma after failure of autologous stem cell transplant
and brentuximab
Safety and tolerability results, a primary
objective in the study, were consistent with other Opdivo
trials
Results from another arm of this Phase 1
study show promising activity with Opdivo in non-Hodgkin
Lymphoma
Bristol-Myers Squibb Company (NYSE:BMY) today announced positive
results from a cohort of patients in its ongoing Phase 1b trial
(CheckMate -039) which evaluated PD-1 immune checkpoint inhibitor,
Opdivo (nivolumab), in patients with relapsed or refractory
hematological malignancies (n=23). Results showed high levels of
response in patients with relapsed or refractory classical Hodgkin
Lymphoma (HL), with an overall response rate of 87% (n=20) and
stable disease in 13% (n=3). These findings were published today in
The New England Journal of Medicine (NEJM) and highlighted in the
press briefing on Saturday, December 6 during the 56th annual
meeting of the American Society for Hematology (Abstract #289).
In patients with HL, initial treatment typically consists of
chemotherapy and/or radiation therapy, followed by an autologous
stem cell transplant (ASCT) if the disease recurs. For those who
relapse within one year after receiving a standard of care like
ASCT, the median survival is only 1.3 years after progression.
“Despite the current treatment landscape, this patient
population is still experiencing relatively short-lived responses
that often result in relapse. So, there is a critical need to
identify new options that can improve outcomes during the course of
their care,” said Philippe Armand, M.D., Ph.D, medical oncologist,
Dana-Farber Cancer Institute and Associate Professor, Department of
Medicine, Harvard Medical School. “These findings with Opdivo are
incredibly encouraging because they show that an immuno-oncology
approach with a check point blockade has the potential to be
applied to lymphomas.”
CheckMate -039 results support the first Breakthrough Therapy
Designation for Opdivo, granted in May 2014 by the U.S. Food and
Drug Administration (FDA) for the treatment of patients with HL
after failure of autologous stem cell transplant and
brentuximab.
“Bristol-Myers Squibb has a long standing commitment to the
treatment of hematologic cancers, and we continue to advance
potential treatment options for this patient population through our
leadership in Immuno-Oncology,” said Michael Giordano, senior vice
president, Head of Development, Oncology, Bristol-Myers Squibb.
“These new data from Opdivo represent the next step towards our
goal of identifying therapies that can transform the standard of
care across a variety of cancer types.”
On Monday, December 8, additional results from CheckMate -039
will be highlighted in a separate oral presentation (Abstract #291)
that could support the potential of Opdivo to treat patients with
relapsed or refractory non-Hodgkin lymphoma. This ongoing Phase 1
trial is also exploring the combination of Opdivo and Yervoy in
hematologic malignancies. Data from that arm of the study will be
published at a later date.
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 -039
CheckMate -039 is an ongoing Phase 1 dose escalation study of
patients with relapsed and refractory hematological malignancies,
which includes a cohort evaluating Opdivo in patients with HL after
failure of autologous stem cell transplant and brentuximab. The
cohort includes 23 patients who were treated with Opdivo 3 mg/kg at
week one, week four and every two weeks until disease progression
or complete response or for a maximum of two years. The primary
endpoints included evaluating the safety and tolerability of
Opdivo. Secondary endpoints included determining antitumor
activity, characterizing Opdivo pharmacokinetics and
immunogenicity, and assessing PD-L1 and PD-L2 expression as a
predictive biomarker.
In the trial, 87% (n=20) achieved an overall response, with 17%
(n=4) achieving complete response and 70% (n=16) a partial
response. The remaining patients, 13% (n=3), experienced stable
disease. Of the patients who achieved a complete and partial
response, 60% (n=12) had their first response within eight weeks
(range: 3-39 weeks). Data from the study also showed a
progression-free survival rate of 86% at 24 weeks, meaning patients
lived six months longer without their disease worsening.
Safety results were reported in all patients treated in the
study. Overall, drug-related adverse events of any grade were
reported in 78% of patients (n=18), with the most common being rash
(22%) and decreased platelet count (17%). Of these, Grade 3 adverse
events occurred in 22% of patients (n=5). There were no
treatment-related Grade 4 or 5 adverse events.
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 50
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 2012, 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 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 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 for Opdivo in advanced
melanoma. The application has also been granted accelerated
assessment by the EMA’s CHMP. The EMA also validated for review the
MAA for nivolumab in NSCLC.
About Hodgkin Lymphoma
Hodgkin lymphoma (HL), also known as Hodgkin disease, is a
cancer of the lymphatic system, which originates in the white blood
cells. HL is one of two main types of lymphomas. The five-year
survival rate for advanced HL is approximately 65 percent in the
U.S. The median age of diagnosis is 38 in the U.S. This year, more
than 9,100 new cases are estimated to be diagnosed with more than
1,100 deaths expected.
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
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.
Bristol-Myers SquibbMedia:Carrie Fernandez,
609-419-5448carrie.fernandez@bms.comorInvestors:Ranya
Dajani, 609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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