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 agent
for 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%). In Checkmate 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.
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