Opdivo is the first and only PD-1 inhibitor
to demonstrate a statistically significant improvement in overall
survival compared to three standard of care options in this
setting, based on CheckMate -141
Data from CheckMate -141 showed survival
benefit with Opdivo in this overall population, regardless
of PD-L1 expression or HPV status
Safety of Opdivo in CheckMate -141
was consistent with prior studies, with no new safety signals
identified
Bristol-Myers Squibb Company (NYSE: BMY) announced today the
first presentation of data from CheckMate -141, a Phase 3
open-label, randomized trial, evaluating Opdivo in patients with
recurrent or metastatic squamous cell carcinoma of the head and
neck (SCCHN) after platinum therapy compared to investigator’s
choice of therapy (methotrexate, docetaxel, or cetuximab). In the
trial, which evaluated overall survival (OS) as the primary
endpoint, patients treated with Opdivo experienced a 30% reduction
in the risk of death, with a median OS of 7.5 months (95% CI:
5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for
investigator’s choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101).
The one-year survival rate for Opdivo was 36% compared to 16.6% for
investigator’s choice. The safety profile of Opdivo in CheckMate
-141 was consistent with prior studies, with no new safety signals
identified.
These data were featured today, Tuesday, April 19, during the
2016 Annual Meeting of the American Association for Cancer Research
(AACR) official press program at 8:30 A.M. CT and will be presented
during the Immuno-Oncology Clinical Trials II Plenary Session from
10:30 A.M. – 12:15 P.M. CT.
Maura Gillison, M.D., Ph.D., lead investigator, Jeg Coughlin
Chair of Cancer Research, The Ohio State University Wexner Medical
Center, commented, "Squamous cell carcinoma of the head and neck
that progresses after platinum-therapy is a devastating disease
with a very poor prognosis. There are no systemic therapies that
improve survival, and therefore, there is a tremendous unmet need
for new treatment options for this patient population. In CheckMate
-141, Opdivo demonstrated an improvement in survival compared to
three standard of care options in this overall patient population,
regardless of PD-L1 expression levels and HPV status.”
Based on a planned interim analysis, this trial was stopped
early in January 2016 because an assessment conducted by the
independent Data Monitoring Committee concluded the study met its
primary endpoint of OS in patients receiving Opdivo compared to the
control arm.
Jean Viallet, M.D., Global Clinical Research Lead, Oncology,
Bristol-Myers Squibb, commented, “We are excited to share, for the
first time, data from the CheckMate -141 trial with the oncology
community at the 2016 AACR Annual Meeting. We are encouraged by the
overall survival results seen with this investigational use of
Opdivo versus three standard of care options for patients with
recurrent or metastatic squamous cell carcinoma of the head and
neck, who often face poor survival rates. These findings are
supportive of our Immuno-Oncology research goal to study potential
treatment options for their ability to help patients with
difficult-to-treat cancers achieve long-term survival.”
About CheckMate -141
CheckMate -141 is a Phase 3, open-label, randomized trial
evaluating Opdivo versus investigator’s choice of therapy in
patients with recurrent or metastatic SCCHN with tumor progression
within six months of platinum therapy in the adjuvant, primary,
recurrent or metastatic setting. Patients were randomized 2:1 to
receive Opdivo 3 mg/kg intravenously over 60 minutes every two
weeks, or one of the following single agents: methotrextate 40
mg/m2 intravenously weekly, docetaxel 30 mg/m2 intravenously
weekly, or cetuximab 400 mg/m2 intravenously once then 250 mg/m2
weekly. Therapies chosen for the control arm represent the most
commonly used therapies in the platinum refractory setting. The
primary endpoint was OS. Secondary endpoints included objective
response rate (ORR) and progression-free survival (PFS). Additional
endpoints included safety.
In the trial, patients treated with Opdivo experienced a
significant reduction (30%) in the risk of death, with a median OS
of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI:
4.0-6.0) for the control arm (HR=0.70 [97.73% CI: 0.51-0.96]
p=0.0101). The one-year OS rate was 36% for Opdivo compared to
16.6% for the control arm.
CheckMate -141 also evaluated the efficacy of Opdivo by HPV
status and PD-L1 expression compared to investigator’s choice of
therapy. HPV testing was performed for patients identified by
investigators with oropharyngeal tumors. In the study, Opdivo
demonstrated improved survival in this overall population,
regardless of HPV status. HPV-positive status was associated with
greater magnitude of effect with Opdivo versus investigator’s
choice. In HPV-positive patients treated with Opdivo, median OS was
9.1 months vs. 4.4 months for patients treated with investigator’s
choice of therapy (HR=0.56 [95% CI: 0.32-0.99]). In HPV-negative
patients treated with Opdivo, median OS was 7.5 months vs. 5.8
months for patients treated with investigator’s choice of therapy
(HR=0.73 [95% CI: 0.42-1.25])
Of randomized patients, 72% (260) were evaluable for PD-L1
expression. Rates of PD-L1 expression were balanced between
subgroups. Opdivo demonstrated improved survival in the overall
population, regardless of PD-L1 expression level (chart below).
Efficacy Summary: Median Overall
Survival by PD-L1 Expression
Hazard Ratio (HR) for Opdivo vs.
Investigator’s Choice Therapy(Median OS, mos)
>1% PD-L1 expression level HR=0.55
[95% CI: 0.36-0.83]
8.7 mos vs. 4.6 mos
(95% CI: 5.7-9.1) (95% CI: 3.8-5.8)
<1% PD-L1 expression level HR=0.89
[95% CI: 0.54-1.45]
5.7 mos vs. 5.8 mos
(95% CI: 4.4-12.7) (95% CI: 4.0-9.8)
The safety profile of Opdivo in CheckMate -141 was consistent
with prior studies with no new safety signals identified.
Treatment-related adverse events (TRAEs) of any grade occurred in
58.9% of patients on Opdivo vs. 77.5% of patients on investigator’s
choice. Grade 3-4 TRAEs were reported in 13.1% of patients on
Opdivo vs. 35.1% of patients on investigator's choice. Two
drug-related deaths were reported as related to Opdivo (pneumonitis
and hypercalcemia), and one Grade 5 event of lung infection on the
investigator’s choice arm.
About Head & Neck
Cancer
Head and neck cancer is the seventh most common cancer globally,
with an estimated 400,000 to 600,000 new cases per year and 223,000
to 300,000 deaths per year. The five-year survival rate is reported
as less than 4% for metastatic Stage IV disease. Squamous cell
carcinoma of the head and neck (SCCHN) accounts for approximately
90% of all head and neck cancers with global incidence expected to
increase by 17% between 2012 and 2022. Risk factors for SCCHN
include tobacco and alcohol consumption, and the increasing role of
Human Papilloma Virus (HPV) infection leading to rapid increase in
oropharyngeal SCCHN in Europe and North America. Quality of life is
often impacted for SCCHN patients as physiological function
(breathing, swallowing, eating, drinking), personal characteristics
(appearance, speaking, voice), sensory function (taste, smell,
hearing), and psychological/social function can be affected.
Bristol-Myers Squibb &
Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of
cancer care that is focused on Immuno-Oncology, now considered a
major treatment choice alongside surgery, radiation, chemotherapy
and targeted therapies for certain types of cancer.
We have a comprehensive clinical portfolio of investigational
and approved Immuno-Oncology agents, many of which were discovered
and developed by our scientists. Our ongoing Immuno-Oncology
clinical program is looking at broad patient populations, across
multiple solid tumors and hematologic malignancies, and lines of
therapy and histologies, with the intent of powering our trials for
overall survival and other important measures like durability of
response. We pioneered the research leading to the first regulatory
approval for the combination of two Immuno-Oncology agents, and
continue to study the role of combinations in cancer.
We are also investigating other immune system pathways in the
treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1,
GITR, CSF1R, IDO, and LAG-3. These pathways may lead to potential
new treatment options – in combination or monotherapy – to help
patients fight different types of cancers.
Our collaboration with academia, as well as small and large
biotech companies, to research the potential Immuno-Oncology and
non-Immuno-Oncology combinations, helps achieve our goal of
providing new treatment options in clinical practice.
At Bristol-Myers Squibb, we are committed to changing survival
expectations in hard-to-treat cancers and the way patients live
with cancer.
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 a PD-1 immune checkpoint
inhibitor that binds to the checkpoint receptor PD-1 expressed on
activated T-cells, and blocks the binding of PD-L1 and PD-L2,
preventing the PD-1 pathway’s suppressive signaling on the immune
system, including the interference with an anti-tumor immune
response.
Opdivo’s broad global development program is based on
Bristol-Myers Squibb’s understanding of the biology behind
Immuno-Oncology. Our company is at the forefront of researching the
potential of Immuno-Oncology to extend survival in hard-to-treat
cancers. This scientific expertise serves as the basis for the
Opdivo development program, which includes a broad range of Phase 3
clinical trials evaluating overall survival as the primary endpoint
across a variety of tumor types. The Opdivo trials have also
contributed toward the clinical and scientific understanding of the
role of biomarkers and how patients may benefit from Opdivo across
the continuum of PD-L1 expression. To date, the Opdivo clinical
development program has enrolled more than 18,000 patients.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive
regulatory approval anywhere in the world in July 2014, and
currently has regulatory approval in 50 countries including the
United States, Japan, and in the European Union.
U.S. FDA APRPOVED
INDICATIONS
OPDIVO® (nivolumab) as a single agent is indicated for the
treatment of patients with BRAF V600 wild-type unresectable or
metastatic melanoma.
OPDIVO® (nivolumab) as a single agent is indicated for the
treatment of patients with BRAF V600 mutation-positive unresectable
or metastatic melanoma. This indication is approved under
accelerated approval based on progression-free survival. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients
with metastatic non-small cell lung cancer (NSCLC) with progression
on or after platinum-based chemotherapy. Patients with EGFR or ALK
genomic tumor aberrations should have disease progression on
FDA-approved therapy for these aberrations prior to receiving
OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients
with advanced renal cell carcinoma (RCC) who have received prior
anti-angiogenic therapy.
IMPORTANT SAFETY
INFORMATION
Immune-Mediated Pneumonitis
Immune-mediated pneumonitis, including fatal cases, occurred
with OPDIVO treatment. Across the clinical trial experience with
solid tumors, fatal immune-mediated pneumonitis occurred with
OPDIVO. Monitor patients for signs with radiographic imaging and
symptoms of pneumonitis. Administer corticosteroids for Grade 2 or
greater pneumonitis. Permanently discontinue for Grade 3 or 4 and
withhold until resolution for Grade 2. In Checkmate 037, 066, and
067, immune-mediated pneumonitis occurred in 1.8% (14/787) of
patients receiving OPDIVO: Grade 3 (n=2) and Grade 2 (n=12). In
Checkmate 057, immune-mediated pneumonitis, including interstitial
lung disease, occurred in 3.4% (10/287) of patients: Grade 3 (n=5),
Grade 2 (n=2), and Grade 1 (n=3). In Checkmate 025, pneumonitis,
including interstitial lung disease, occurred in 5% (21/406) of
patients receiving OPDIVO and 18% (73/397) of patients receiving
everolimus. Immune-mediated pneumonitis occurred in 4.4% (18/406)
of patients receiving OPDIVO: Grade 4 (n=1), Grade 3 (n=4), Grade 2
(n=12), and Grade 1 (n=1).
Immune-Mediated Colitis
Immune-mediated colitis can occur with OPDIVO treatment. Monitor
patients for signs and symptoms of colitis. Administer
corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4
colitis. As a single agent, withhold OPDIVO for Grade 2 or 3 and
permanently discontinue for Grade 4 or recurrent colitis upon
restarting OPDIVO. In Checkmate 037, 066, and 067, diarrhea or
colitis occurred in 31% (242/787) of patients receiving OPDIVO.
Immune-mediated colitis occurred in 4.1% (32/787) of patients:
Grade 3 (n=20), Grade 2 (n=10), and Grade 1 (n=2). In Checkmate
057, diarrhea or colitis occurred in 17% (50/287) of patients
receiving OPDIVO. Immune-mediated colitis occurred in 2.4% (7/287)
of patients: Grade 3 (n=3), Grade 2 (n=2), and Grade 1 (n=2). In
Checkmate 025, diarrhea or colitis occurred in 25% (100/406) of
patients receiving OPDIVO and 32% (126/397) of patients receiving
everolimus. Immune-mediated diarrhea or colitis occurred in 3.2%
(13/406) of patients receiving OPDIVO: Grade 3 (n=5), Grade 2
(n=7), and Grade 1 (n=1).
Immune-Mediated Hepatitis
Immune-mediated hepatitis can occur with OPDIVO treatment.
Monitor patients for abnormal liver tests prior to and periodically
during treatment. Administer corticosteroids for Grade 2 or greater
transaminase elevations. Withhold for Grade 2 and permanently
discontinue for Grade 3 or 4 immune-mediated hepatitis. In
Checkmate 037, 066, and 067, immune-mediated hepatitis occurred in
2.3% (18/787) of patients receiving OPDIVO: Grade 4 (n=3), Grade 3
(n=11), and Grade 2 (n=4). In Checkmate 057, one patient (0.3%)
developed immune-mediated hepatitis. In Checkmate 025, there was an
increased incidence of liver test abnormalities compared to
baseline in AST (33% vs 39%), alkaline phosphatase (32% vs 32%),
ALT (22% vs 31%), and total bilirubin (9% vs 3.5%) in the OPDIVO
and everolimus arms, respectively. Immune-mediated hepatitis
requiring systemic immunosuppression occurred in 1.5% (6/406) of
patients receiving OPDIVO: Grade 3 (n=5) and Grade 2 (n=1).
Immune-Mediated Endocrinopathies
Hypophysitis, adrenal insufficiency, thyroid disorders, and type
1 diabetes mellitus can occur with OPDIVO treatment. Monitor
patients for signs and symptoms of hypophysitis, signs and symptoms
of adrenal insufficiency during and after treatment, thyroid
function prior to and periodically during treatment, and
hyperglycemia. Administer corticosteroids for Grade 2 or greater
hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue
for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or
4 adrenal insufficiency. Withhold for Grade 2 and permanently
discontinue for Grade 3 or 4 adrenal insufficiency. Administer
hormone-replacement therapy for hypothyroidism. Initiate medical
management for control of hyperthyroidism. Administer insulin for
type 1 diabetes. Withhold OPDIVO for Grade 3 and permanently
discontinue for Grade 4 hyperglycemia.
In Checkmate 037, 066, and 067, hypophysitis occurred in 0.9%
(7/787) of patients receiving OPDIVO: Grade 3 (n=2), Grade 2 (n=3),
and Grade 1 (n=2). In Checkmate 025, hypophysitis occurred in 0.5%
(2/406) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 1
(n=1). In Checkmate 037, 066, and 067, adrenal insufficiency
occurred in 1% (8/787) of patients receiving OPDIVO: Grade 3 (n=2),
Grade 2 (n=5), and Grade 1 (n=1). In Checkmate 057, 0.3% (1/287) of
OPDIVO-treated patients developed adrenal insufficiency. In
Checkmate 025, adrenal insufficiency occurred in 2.0% (8/406) of
patients receiving OPDIVO: Grade 3 (n=3), Grade 2 (n=4), and Grade
1 (n=1). In Checkmate 037, 066, and 067, hypothyroidism or
thyroiditis occurred in 9% (73/787) of patients receiving OPDIVO:
Grade 3 (n=1), Grade 2 (n=37), Grade 1 (n=35). Hyperthyroidism
occurred in 4.4% (35/787) of patients receiving OPDIVO: Grade 3
(n=1), Grade 2 (n=12), and Grade 1 (n=22). In Checkmate 057, Grade
1 or 2 hypothyroidism, including thyroiditis, occurred in 7%
(20/287) and elevated thyroid stimulating hormone occurred in 17%
of patients receiving OPDIVO. Grade 1 or 2 hyperthyroidism occurred
in 1.4% (4/287) of patients. In Checkmate 025, thyroid disease
occurred in 11% (43/406) of patients receiving OPDIVO, including
one Grade 3 event, and in 3.0% (12/397) of patients receiving
everolimus. Hypothyroidism/thyroiditis occurred in 8% (33/406) of
patients receiving OPDIVO: Grade 3 (n=2), Grade 2 (n=17), and Grade
1 (n=14). Hyperthyroidism occurred in 2.5% (10/406) of patients
receiving OPDIVO: Grade 2 (n=5) and Grade 1 (n=5). In Checkmate
037, 066, and 067, diabetes mellitus or diabetic ketoacidosis
occurred in 0.8% (6/787) of patients receiving OPDIVO: Grade 3
(n=2), Grade 2 (n=3), and Grade 1 (n=1). In Checkmate 025,
hyperglycemic adverse events occurred in 9% (37/406) patients.
Diabetes mellitus or diabetic ketoacidosis occurred in 1.5% (6/406)
of patients receiving OPDIVO: Grade 3 (n=3), Grade 2 (n=2), and
Grade 1 (n=1).
Immune-Mediated Nephritis and Renal Dysfunction
Immune-mediated nephritis can occur with OPDIVO treatment.
Monitor patients for elevated serum creatinine prior to and
periodically during treatment. For Grade 2 or 3 increased serum
creatinine, withhold and administer corticosteroids; if worsening
or no improvement occurs, permanently discontinue. Administer
corticosteroids for Grade 4 serum creatinine elevation and
permanently discontinue. In Checkmate 037, 066, and 067, nephritis
and renal dysfunction of any grade occurred in 5% (40/787) of
patients receiving OPDIVO. Immune-mediated nephritis and renal
dysfunction occurred in 0.8% (6/787) of patients: Grade 3 (n=4) and
Grade 2 (n=2). In Checkmate 057, Grade 2 immune-mediated renal
dysfunction occurred in 0.3% (1/287) of patients receiving OPDIVO.
In Checkmate 025, renal injury occurred in 7% (27/406) of patients
receiving OPDIVO and 3.0% (12/397) of patients receiving
everolimus. Immune-mediated nephritis and renal dysfunction
occurred in 3.2% (13/406) of patients receiving OPDIVO: Grade 5
(n=1), Grade 4 (n=1), Grade 3 (n=5), and Grade 2 (n=6).
Immune-Mediated Rash
Immune-mediated rash can occur with OPDIVO treatment. Severe
rash (including rare cases of fatal toxic epidermal necrolysis)
occurred in the clinical program of OPDIVO. Monitor patients for
rash. Administer corticosteroids for Grade 3 or 4 rash. Withhold
for Grade 3 and permanently discontinue for Grade 4. In Checkmate
037, 066, and 067, immune-mediated rash occurred in 9% (72/787) of
patients receiving OPDIVO: Grade 3 (n=7), Grade 2 (n=15), and Grade
1 (n=50). In Checkmate 057, immune-mediated rash occurred in 6%
(17/287) of patients receiving OPDIVO including four Grade 3 cases.
In Checkmate 025, rash occurred in 28% (112/406) of patients
receiving OPDIVO and 36% (143/397) of patients receiving
everolimus. Immune-mediated rash, defined as a rash treated with
systemic or topical corticosteroids, occurred in 7% (30/406) of
patients receiving OPDIVO: Grade 3 (n=4), Grade 2 (n=7), and Grade
1 (n=19).
Immune-Mediated Encephalitis
Immune-mediated encephalitis can occur with OPDIVO treatment.
Withhold OPDIVO in patients with new-onset moderate to severe
neurologic signs or symptoms and evaluate to rule out other causes.
If other etiologies are ruled out, administer corticosteroids and
permanently discontinue OPDIVO for immune-mediated encephalitis. In
Checkmate 057, fatal limbic encephalitis occurred in one patient
(0.3%) receiving OPDIVO.
Other Immune-Mediated Adverse Reactions
Based on the severity of adverse reaction, permanently
discontinue or withhold treatment, administer high-dose
corticosteroids, and, if appropriate, initiate hormone-replacement
therapy. In < 1.0% of patients receiving OPDIVO, the following
clinically significant, immune-mediated adverse reactions occurred:
uveitis, pancreatitis, facial and abducens nerve paresis,
demyelination, polymyalgia rheumatica, autoimmune neuropathy,
Guillain-Barré syndrome, hypopituitarism, systemic inflammatory
response syndrome, gastritis, duodenitis, and sarcoidosis. Across
clinical trials of OPDIVO as a single agent administered at doses
of 3 mg/kg and 10 mg/kg, additional clinically significant,
immune-mediated adverse reactions were identified: motor
dysfunction, vasculitis, and myasthenic syndrome.
Infusion Reactions
Severe infusion reactions have been reported in <1.0% of
patients in clinical trials of OPDIVO. Discontinue OPDIVO in
patients with Grade 3 or 4 infusion reactions. Interrupt or slow
the rate of infusion in patients with Grade 1 or 2. In Checkmate
037, 066, and 067, Grade 2 infusion related reactions occurred in
2.7% (21/787) of patients receiving OPDIVO: Grade 3 (n=2), Grade 2
(n=8), and Grade 1 (n=11). In Checkmate 057, Grade 2 infusion
reactions requiring corticosteroids occurred in 1.0% (3/287) of
patients receiving OPDIVO. In Checkmate 025,
hypersensitivity/infusion-related reactions occurred in 6% (25/406)
of patients receiving OPDIVO and 1.0% (4/397) of patients receiving
everolimus.
Embryo-fetal Toxicity
Based on its mechanism of action, OPDIVO can cause fetal harm
when administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment with an OPDIVO-
containing regimen and for at least 5 months after the last dose of
OPDIVO.
Lactation
It is not known whether OPDIVO is present in human milk. Because
many drugs, including antibodies, are excreted in human milk and
because of the potential for serious adverse reactions in nursing
infants from an OPDIVO-containing regimen, advise women to
discontinue breastfeeding during treatment.
Serious Adverse Reactions
In Checkmate 067, serious adverse reactions (37%), adverse
reactions leading to permanent discontinuation (14%) or to dosing
delays (28%), and Grade 3 or 4 adverse reactions (72%) occurred in
the OPDIVO arm. The most frequent (≥10%) serious adverse reactions
in the OPDIVO arm were diarrhea (2.6%), colitis (1.6%), and pyrexia
(0.6%). In Checkmate 037, serious adverse reactions occurred in 41%
of patients receiving OPDIVO. Grade 3 and 4 adverse reactions
occurred in 42% of patients receiving OPDIVO. The most frequent
Grade 3 and 4 adverse drug reactions reported in 2% to <5% of
patients receiving OPDIVO were abdominal pain, hyponatremia,
increased aspartate aminotransferase, and increased lipase. In
Checkmate 066, serious adverse reactions occurred in 36% of
patients receiving OPDIVO. Grade 3 and 4 adverse reactions occurred
in 41% of patients receiving OPDIVO. The most frequent Grade 3 and
4 adverse reactions reported in ≥2% of patients receiving OPDIVO
were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%).
In Checkmate 057, serious adverse reactions occurred in 47% of
patients receiving OPDIVO. The most frequent serious adverse
reactions reported in ≥2% of patients were pneumonia, pulmonary
embolism, dyspnea, pleural effusion, and respiratory failure. In
Checkmate 025, serious adverse reactions occurred in 47% of
patients receiving OPDIVO. The most frequent serious adverse
reactions reported in ≥2% of patients were acute kidney injury,
pleural effusion, pneumonia, diarrhea, and hypercalcemia.
Common Adverse Reactions
In Checkmate 067, the most common (≥20%) adverse reactions in
the OPDIVO arm were fatigue (53%), rash (40%), diarrhea (31%), and
nausea (28%). In Checkmate 037, the most common adverse reaction
(≥20%) reported with OPDIVO was rash (21%). In Checkmate 066, the
most common adverse reactions (≥20%) reported with OPDIVO vs
dacarbazine were fatigue (49% vs 39%), musculoskeletal pain (32% vs
25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate
057, the most common adverse reactions (≥20%) reported with OPDIVO
were fatigue (49%), musculoskeletal pain (36%), cough (30%),
decreased appetite (29%), and constipation (23%). In Checkmate 025,
the most common adverse reactions (≥20%) reported in patients
receiving OPDIVO vs everolimus were asthenic conditions (56% vs
57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%),
dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs
18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and
arthralgia (20% vs 14%).
About the Bristol-Myers Squibb and Ono
Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono
Pharmaceutical Co., Ltd (Ono) 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 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 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 us at www.BMS.com or
follow us on LinkedIn, Twitter, and YouTube.
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 for an additional
indication in SCCHN. 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,
2015 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.
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Bristol-Myers Squibb CompanyMedia:Audrey Abernathy,
609-419-5375Cell:
919-605-4521audrey.abernathy@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.com
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