Company Website:
http://www.bms.com
PRINCETON, N.J. -- (Business Wire)
Bristol-Myers
Squibb Company (NYSE:BMY) today announced that the U.S. Food and
Drug Administration (FDA) has issued a Complete Response Letter for its
supplemental Biologics License Application (sBLA) for Opdivo (nivolumab)
as a single agent for the treatment of previously untreated patients,
specifically those with BRAF V600 mutation positive unresectable
or metastatic melanoma.
As part of the Complete Response Letter, the FDA indicated the need for
additional data in the BRAF mutated patient population.
Bristol-Myers Squibb is working to evaluate the request outlined by the
FDA and will continue to work closely with the agency to determine
whether additional data, currently under review, adequately addresses
these comments.
The sBLA submitted for Opdivo as a single agent for previously
untreated metastatic melanoma was based on clinical data from the Phase
3 CheckMate -066 trial which evaluated Opdivo in treatment-naïve
patients with BRAF wild-type advanced melanoma compared to
dacarbazine. The FDA approved Opdivo as a single agentfor
the treatment of patients with BRAF wild-type unresectable or
metastatic melanoma, based on CheckMate -066, on November 23, 2015. In
addition to data from CheckMate -066, the Company submitted data for Opdivo
in BRAF V600 mutation positive metastatic melanoma, which was the
subject of the FDA’s Complete Response Letter.
A separate sBLA, which included data from CheckMate -067 evaluating Opdivo
as a single agent and in combination with Yervoy (ipilimumab)
in patients with previously untreated advanced melanoma, was accepted by
the FDA for review in September and granted Priority Review with a
target action date of January 23, 2016. Data for Opdivo monotherapy
in both BRAF wild-type and BRAF V600 mutation positive
advanced melanoma was included as part of this application.
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
research in an innovative 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
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.
INDICATIONS and IMPORTANT SAFETY INFORMATION
for OPDIVO (nivolumab)
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 unresectable or metastatic, BRAF V600 mutation-positive
melanoma and disease progression following ipilimumab and a BRAF
inhibitor. This indication is approved under accelerated approval based
on tumor response rate and durability of response. Continued approval
for this indication may be contingent upon verification and description
of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab), in combination with (ipilimumab), is indicated for
the treatment of patients with BRAF V600 wild-type, unresectable or
metastatic melanoma. This indication is approved under accelerated
approval based on tumor response rate and durability of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the 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
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse
reactions. These immune-mediated reactions may involve any organ system;
however, the most common severe immune-mediated adverse reactions are
enterocolitis, hepatitis, dermatitis (including toxic epidermal
necrolysis), neuropathy, and endocrinopathy. The majority of these
immune-mediated reactions initially manifested during treatment;
however, a minority occurred weeks to months after discontinuation of
YERVOY.
Assess patients for signs and symptoms of enterocolitis, dermatitis,
neuropathy, and endocrinopathy and evaluate clinical chemistries
including liver function tests (LFTs), adrenocorticotropic hormone
(ACTH) level, and thyroid function tests at baseline and before each
dose.
Permanently discontinue YERVOY and initiate systemic high-dose
corticosteroid therapy for severe immune-mediated reactions.
Immune-Mediated Pneumonitis
Immune-mediated pneumonitis or interstitial lung disease, including
fatal cases, occurred with OPDIVO treatment. Across the clinical trial
experience with solid tumors, fatal immune-mediated pneumonitis occurred
with OPDIVO. In addition, in Checkmate 069, there were six patients who
died without resolution of abnormal respiratory findings. 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, pneumonitis, including
interstitial lung disease, occurred in 3.4% (9/268) of patients
receiving OPDIVO and none of the 102 patients receiving chemotherapy.
Immune-mediated pneumonitis occurred in 2.2% (6/268) of patients
receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=5). In Checkmate 066,
immune-mediated pneumonitis occurred in 1.4% (3/206) of patients
receiving OPDIVO and in none of the 205 patients receiving dacarbazine:
Grade 2 (n=3). 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). In Checkmate 069, pneumonitis,
including interstitial lung disease, occurred in 10% (9/94) of patients
receiving OPDIVO in combination with YERVOY and 2.2% (1/46) of patients
receiving YERVOY. Immune-mediated pneumonitis occurred in 6% (6/94) of
patients receiving OPDIVO in combination with YERVOY: Grade 5 (n=1),
Grade 3 (n=2) and Grade 2 (n=3).
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 combination with
YERVOY, withhold OPDIVO for Grade 2 and permanently discontinue for
Grade 3 or 4 or recurrent colitis upon restarting OPDIVO. In Checkmate
037, diarrhea or colitis occurred in 21% (57/268) of patients receiving
OPDIVO and 18% (18/102) of patients receiving chemotherapy.
Immune-mediated colitis occurred in 2.2% (6/268) of patients receiving
OPDIVO; Grade 3 (n=5) and Grade 2 (n=1). In Checkmate 066, diarrhea or
colitis occurred in 28% (58/206) of patients receiving OPDIVO and 25%
(52/205) of patients receiving dacarbazine. Immune-mediated colitis
occurred in 4.9% (10/206) of patients receiving OPDIVO: Grade 3 (n=5)
and Grade 2 (n=5). 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). In Checkmate 069, diarrhea or colitis occurred in 57%
(54/94) of patients receiving OPDIVO in combination with YERVOY and 46%
(21/46) of patients receiving YERVOY. Immune-mediated colitis occurred
in 33% (31/94) of patients receiving OPDIVO in combination with YERVOY:
Grade 4 (n=1), Grade 3 (n=16), Grade 2 (n=9), and Grade 1 (n=5).
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening,
or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal
signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%)
patients. Across all YERVOY-treated patients in that study (n=511), 5
(1%) developed intestinal perforation, 4 (0.8%) died as a result of
complications, and 26 (5%) were hospitalized for severe enterocolitis.
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, there was an increased incidence of liver test abnormalities in the
OPDIVO-treated group as compared to the chemotherapy-treated group, with
increases in AST (28% vs 12%), alkaline phosphatase (22% vs 13%), ALT
(16% vs 5%), and total bilirubin (9% vs 0). Immune-mediated hepatitis
occurred in 1.1% (3/268) of patients receiving OPDIVO; Grade 3 (n=2) and
Grade 2 (n=1). In Checkmate 066, there was an increased incidence of
liver test abnormalities in the OPDIVO-treated group as compared to the
dacarbazine-treated group, with increases in ALT (25% vs. 19%), AST (24%
vs. 19%), alkaline phosphatase (21% vs. 14%), and total bilirubin (13%
vs. 6%). Immune-mediated hepatitis occurred in 0.9% (2/206) of patients
receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=1). 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-treated and
everolimus-treated groups, 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). In Checkmate
069, immune-mediated hepatitis occurred in 15% (14/94) of patients
receiving OPDIVO in combination with YERVOY: Grade 4 (n=3), Grade 3
(n=9), and Grade 2 (n=2).
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening,
or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total
bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients,
with fatal hepatic failure in 0.2% and hospitalization in 0.4%.
Immune-Mediated Dermatitis
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening,
or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic
epidermal necrolysis, or rash complicated by full thickness dermal
ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade
3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result
of toxic epidermal necrolysis. 1 additional patient required
hospitalization for severe dermatitis.
Immune-Mediated Neuropathies
In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal
Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor
neuropathy were reported.
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 025, hypophysitis occurred in 0.5% (2/406) of patients
receiving OPDIVO: Grade 3 (n=1) and Grade 1 (n=1). In Checkmate 069,
hypophysitis occurred in 13% (12/94) of patients receiving OPDIVO in
combination with YERVOY: Grade 3 (n=2) and Grade 2 (n=10). In Checkmate
037, 066, 057, <1.0% 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 069, adrenal insufficiency occurred in 9%
(8/94) of patients receiving OPDIVO in combination with YERVOY: Grade 3
(n=3), Grade 2 (n=4), and Grade 1 (n=1). In Checkmate 037, Grade 1 or 2
hypothyroidism occurred in 8% (21/268) of patients receiving OPDIVO and
none of the 102 patients receiving chemotherapy. Grade 1 or 2
hyperthyroidism occurred in 3.0% (8/268) of patients receiving OPDIVO
and 1.0% (1/102) of patients receiving chemotherapy. In Checkmate 066,
hypothyroidism occurred in 7% (14/206) of patients receiving OPDIVO
(Grade 3 (n=1)) and 0.9% (2/205) of patients receiving dacarbazine.
Hyperthyroidism occurred in 4.4% (9/206) of patients receiving OPDIVO
(Grade 3 (n=1)) and 0.9% (2/205) of patients receiving dacarbazine. In
Checkmate 057, Grade 1 or 2 hypothyroidism, including thyroiditis,
occurred in 7% (20/287) and elevated TSH 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 069, hypothyroidism occurred in 19% (18/94) of patients
receiving OPDIVO in combination with YERVOY. All were Grade 1 or 2 in
severity except for one patient who experienced Grade 3 autoimmune
thyroiditis. Grade 1 hyperthyroidism occurred in 2.1% (2/94) of patients
receiving OPDIVO in combination with YERVOY. In Checkmate 066, diabetes
mellitus or diabetic ketoacidosis occurred in 1.0% (2/206) of patients
receiving OPDIVO and none of the 205 receiving dacarbazine; Grade 3
diabetic ketoacidosis (n=1) and Grade 2 diabetes mellitus (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).
In a separate Phase 3 study of YERVOY 3 mg/kg, severe to
life-threatening immune-mediated endocrinopathies (requiring
hospitalization, urgent medical intervention, or interfering with
activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients.
All 9 patients had hypopituitarism, and some had additional concomitant
endocrinopathies such as adrenal insufficiency, hypogonadism, and
hypothyroidism. 6 of the 9 patients were hospitalized for severe
endocrinopathies.
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,
there was an increased incidence of elevated creatinine in the
OPDIVO-treated group as compared to the chemotherapy-treated group (13%
vs 9%). Grade 2 or 3 immune-mediated nephritis or renal dysfunction
occurred in 0.7% (2/268) of patients. In Checkmate 066, there was an
increased incidence of elevated creatinine in the OPDIVO-treated group
as compared to the dacarbazine-treated group (11% vs. 10%). Grade 3
immune-mediated renal dysfunction occurred in 0.5% (1/206) of patients.
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).
In Checkmate 069, Grade 2 or higher immune-mediated nephritis or renal
dysfunction occurred in 2.1% (2/94) of patients. One patient died
without resolution of renal dysfunction.
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 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). In
Checkmate 069, immune-mediated rash occurred in 37% (35/94) of patients
receiving OPDIVO in combination with YERVOY: Grade 3 (n=6), Grade 2
(n=10), 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. Across clinical trials of 8490
patients receiving OPDIVO as a single agent or in combination with
YERVOY, <1.0% of patients were identified as having 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. The following
clinically significant immune-mediated adverse reactions occurred in
<1.0% of OPDIVO-treated patients: uveitis, pancreatitis, facial and
abducens nerve paresis, demyelination, polymyalgia rheumatica,
autoimmune neuropathy, Guillain-Barre syndrome, hypopituitarism and
systemic inflammatory response syndrome. Across clinical trials of
OPDIVO administered as a single agent at doses 3 mg/kg and 10 mg/kg,
additional clinically significant, immune-mediated adverse reactions
were identified: motor dysfunction, vasculitis, and myasthenic syndrome.
Across clinical trials of OPDIVO in combination with YERVOY, the
following additional clinically significant, immune-mediated adverse
reactions were identified: sarcoidosis, duodenitis, and gastritis.
Infusion Reactions
Severe infusion reactions have been reported in <1.0% of patients in
clinical trials of OPDIVO as a single agent. 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 057 and
066, Grade 2 infusion reactions occurred in 1.0% (5/493) 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. In Checkmate 069, Grade 2
infusion reactions occurred in 3.2% (3/94) of patients receiving OPDIVO
in combination with YERVOY.
Embryofetal Toxicity
Based on their mechanisms of action, OPDIVO and YERVOY 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- or YERVOY-
containing regimen and for at least 5 months after the last dose of
OPDIVO.
Lactation
It is not known whether OPDIVO or YERVOY 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 OPDIVO-containing regimen, advise women to discontinue
breastfeeding during treatment. Advise women to discontinue nursing
during treatment with YERVOY and for 3 months following the final dose.
Serious Adverse Reactions
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. In Checkmate 069, serious adverse reactions occurred in
62% of patients receiving OPDIVO; the most frequent serious adverse
events with OPDIVO in combination with YERVOY, as compared to YERVOY
alone, were colitis (17% vs 9%), diarrhea (9% vs 7%), pyrexia (6% vs
7%), and pneumonitis (5% vs 0).
Common Adverse Reactions
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%). InCheckmate 069, the most common
adverse reactions (≥20%) reported in patients receiving OPDIVO in
combination with YERVOY vs YERVOY alone were rash (67% vs 57%), pruritus
(37% vs 26%), headache (24% vs 20%), vomiting (23% vs 15%), and colitis
(22% vs 11%).
In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse
reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue
(41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).
Please
see U.S. Full Prescribing Information, including Boxed WARNING regarding
immune-mediated adverse reactions for YERVOY.
Please
see U.S. Full Prescribing Information for OPDIVO.
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 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.
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, 2014 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151127005373/en/
Contacts:
Bristol-Myers Squibb Company
Media Inquiries:
Jaisy
Wagner Styles
Office: 609-897-3958
Cell: 610-291-5168
jaisy.styles@bms.com
or
Investors:
Ranya
Dajani
Office: 609-252-5330
ranya.dajani@bms.com
or
Bill
Szablewski
Office: 609-252-5894
william.szablewski@bms.com
Source: Bristol-Myers Squibb Company
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