Yervoy demonstrated a 28% reduction in the
risk of death versus placebo in first disclosure of overall
survival data from pivotal study CA184-029 (EORTC 18071)
Risk of distant metastasis was reduced by
24% with Yervoy compared to placebo
With longer follow-up, the recurrence-free
survival benefit and safety profile remained consistent with the
previously reported primary analysis
Bristol-Myers Squibb Company (NYSE: BMY) announced today
superior efficacy with Yervoy 10 mg/kg versus placebo on all
survival endpoints in the Phase 3 trial CA184-029 (EORTC 18071)
evaluating stage III melanoma patients who are at high risk of
recurrence following complete surgical resection. In the study,
Yervoy compared with placebo significantly improved overall
survival (OS) (HR=0.72 [95.1% CI: 0.58-0.88; p=0.001]), a secondary
endpoint, with five-year OS rates at 65.4% in the Yervoy group and
54.4% in the placebo group. Distant metastasis-free survival
(DMFS), a secondary endpoint, was also significantly improved
versus placebo (HR=0.76 [95.8% CI: 0.64-0.92; p=0.002]) and had
five-year DMFS rates of 48.3% and 38.9% in the Yervoy and placebo
groups, respectively. In this updated five-year analysis, the
recurrence-free survival (primary endpoint) benefit observed
previously with Yervoy was maintained (HR=0.76 [95% CI: 0.64-0.89;
p<0.001). The safety profile remained consistent with the
initial analysis, with no new deaths or safety signals. The most
common grade 3/4 immune-related adverse events in the Yervoy group
were gastrointestinal (16.1%), hepatic (10.8%), and endocrine
(7.9%).
These data were featured today, October 8, during the 2016
European Society for Medical Oncology Congress Press Program and
simultaneously published in The New England Journal of Medicine.
The data will also be presented today during a Presidential
Symposium from 5:00-5:15 p.m. CEST (Abstract #LBA2_PR).
“Despite surgical intervention, most patients with stage III
melanoma experience disease recurrence and progress to metastatic
disease, reinforcing the unmet need for effective systemic
therapies in the adjuvant setting,” said Alexander M.M. Eggermont,
M.D., Ph.D., director general, Cancer Institute Gustave Roussy in
Villejuif, France. “The impact of Yervoy on overall survival,
distant-metastasis free survival, and recurrence-free survival
observed in study -029 offers physicians new insights in the
treatment of adjuvant melanoma.”
In stage III melanoma, the disease has not yet spread to distant
lymph nodes or to other parts of the body and requires surgical
resection of the primary tumor as well as the involved lymph nodes.
The stage III patient population is heterogeneous with
disease-specific survival rates of 78%, 59%, and 40% for stage
IIIA, IIIB, and IIIC melanoma, respectively.
“The results from study -029 are important data for the
scientific community and underscore our ongoing dedication to
improving survival across stages of melanoma,” said Vicki Goodman,
M.D., development lead, Melanoma and Genitourinary Cancers,
Bristol-Myers Squibb. “Yervoy is the first immune checkpoint
inhibitor to demonstrate a statistically significant survival
benefit for high-risk patients with fully resected stage III
melanoma. With further evaluation of our Immuno-Oncology agents and
different dosing options, we remain committed to further research
across the full continuum of melanoma treatment.”
About CA184-029 (EORTC
18071)
CA184-029 (EORTC 18071), a study initiated in 2008 by the
European Organization for Research and Treatment of Cancer (EORTC),
is a Phase 3, double-blind, placebo-controlled randomized trial
evaluating the efficacy and safety of Yervoy 10 mg/kg in the
adjuvant setting for high-risk stage III melanoma. The
independently-run trial involved 99 centers across 19 countries
from the EORTC’s pan-European network and specialized
infrastructure. The trial enrolled eligible patients, which
included those ≥18 years of age who underwent complete resection of
stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm
or in-transit metastasis). In the trial, patients were randomized
to receive Yervoy 10 mg/kg (n=475) or placebo (n=476) as
an intravenous infusion every 3 weeks for 4 doses, followed
by Yervoy 10 mg/kg or placebo every 12 weeks from Week 24
to Week 156 (three years), or until documented disease recurrence
or unacceptable toxicity. Yervoy was studied across a
broad range of patient characteristics, including patients with
stage IIIa with lymph node >1 mm (20%), IIIb (44%) or IIIc with
no in-transit metastases (36%); 42% had ulcerated primary lesions,
and 58% had macroscopic lymph node involvement.
The primary endpoint was recurrence-free survival (RFS), defined
as the time between the date of randomization and the date of first
recurrence or death, as assessed by the Independent Review
Committee. This analysis was the basis of the Yervoy approval in
the United States for adjuvant treatment of melanoma at a dose of
10 mg/kg in October 2015. Secondary endpoints include overall
survival (OS), distant metastases-free survival (DMFS), safety and
health-related quality of life.
In the study, Yervoy significantly improved RFS, the
primary endpoint, versus placebo across all patient groups. Updated
five-year results demonstrated RFS remained significantly longer
for Yervoy versus placebo, with a median RFS of 27.6 months (95%
CI: 19.3-37.2) versus 17.1 months (95% CI: 13.6-21.6), respectively
(HR=0.76; 95% CI: 0.64-0.89; p<0.001).
Yervoy also demonstrated a significant improvement in OS, a
secondary endpoint of the study, with a 28% reduction in the risk
of death versus placebo (HR=0.72 [95% CI: 0.58-0.88; p=0.001]) and
an estimated five-year OS rate of 65.4% (95% CI: 60.8-69.6) for
Yervoy versus 54.4% (95% CI: 49.7-58.9) for placebo. In addition,
Yervoy showed a 24% reduction in the risk of developing distant
metastases versus placebo (HR=0.76 [95.8% CI: 0.64-0.92; p=0.002]),
with an estimated five-year DMFS rate of 48.3% with Yervoy versus
38.9% with placebo. The median DMFS was 48.3 months with Yervoy
versus 27.5 months with placebo.
The safety profile of Yervoy based on this updated analysis was
consistent with previously reported findings from CA184-029 (EORTC
18071). In those initial findings, five patient deaths occurred due
to drug-related adverse events (AE); no new deaths have since been
reported. Among the 471 patients who received Yervoy, 465 (98.7%)
experienced an AE of any grade, and 255 patients (54.1%)
experienced a grade 3 or 4 AE, whereas among 474 placebo-treated
patients, 432 (91.1%) experienced an AE of any grade, and 124
patients (26.2%) experienced a grade 3 or 4 AE. Immune-related AEs
were more frequent with Yervoy than with placebo. The most common
grade 3/4 immune-related AEs in the Yervoy group were
gastrointestinal (16.1%), hepatic (10.8%), and endocrine (7.9%).
The median time to onset of on-study grade 2-5 immune-related AEs
ranged from 4.0 weeks (skin immune-related adverse events) to 13.1
weeks (neurological immune-related adverse events). Endocrine grade
2-4 immune-related AEs resolved in 51.5% of patients, and median
time to resolution was 54.3 weeks. The majority (82-97%) of all
other grade 2-4 immune-related AEs resolved, and median time to
resolution ranged from 4.0 to 8.0 weeks.
About Advanced Melanoma
Melanoma is a form of skin cancer characterized by the
uncontrolled growth of pigment-producing cells (melanocytes)
located in the skin. Metastatic melanoma is the deadliest form of
the disease and occurs when cancer spreads beyond the surface of
the skin to the other organs, such as the lymph nodes, lungs, brain
or other areas of the body. Melanoma is separated into five staging
categories (Stages 0-IV) based on the in-situ feature, thickness,
and ulceration of the tumor, whether the cancer has spread to the
lymph nodes, and how far the cancer has spread beyond lymph nodes.
Stage III melanoma has reached the regional lymph nodes but has not
yet spread to distant lymph nodes or to other parts of the body
(metastasized) and requires surgical resection of the primary tumor
as well as the local lymph nodes.
Bristol-Myers Squibb: At the Forefront
of Immuno-Oncology Science & Innovation
At Bristol-Myers Squibb, patients are at the center of
everything we do. Our vision for the future of cancer care is
focused on researching and developing transformational
Immuno-Oncology (I-O) medicines that will raise survival
expectations in hard-to-treat cancers and will change the way
patients live with cancer.
We are leading the scientific understanding of I-O through our
extensive portfolio of investigational and approved agents,
including the first combination of two I-O agents in metastatic
melanoma, and our differentiated clinical development program,
which is studying broad patient populations across more than 20
types of cancers with 11 clinical-stage molecules designed to
target different immune system pathways. Our deep expertise and
innovative clinical trial designs uniquely position us to advance
the science of combinations across multiple tumors and potentially
deliver the next wave of I-O combination regimens with a sense of
urgency. We also continue to pioneer research that will help
facilitate a deeper understanding of the role of immune biomarkers
and inform which patients will benefit most from I-O therapies.
We understand making the promise of I-O a reality for the many
patients who may benefit from these therapies requires not only
innovation on our part but also close collaboration with leading
experts in the field. Our partnerships with academia, government,
advocacy and biotech companies support our collective goal of
providing new treatment options to advance the standards of
clinical practice.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody that
binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).
CTLA-4 is a negative regulator of T-cell
activity. Yervoy binds to CTLA-4 and blocks the
interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of
CTLA-4 has been shown to augment T-cell activation and
proliferation, including the activation and proliferation of tumor
infiltrating T-effector cells. Inhibition of CTLA-4 signaling can
also reduce T-regulatory cell function, which may contribute to a
general increase in T-cell responsiveness, including the anti-tumor
immune response. On March 25, 2011, the U.S. Food and Drug
Administration (FDA) approved Yervoy 3 mg/kg monotherapy
for patients with unresectable or metastatic
melanoma. Yervoy is approved for unresectable or
metastatic melanoma in more than 50 countries. There is a broad,
ongoing development program in place for Yervoy spanning
multiple tumor types.
U.S. Indications and Important Safety Information for
YERVOY® (ipilimumab)
Indications
YERVOY® (ipilimumab) is indicated for the treatment of
unresectable or metastatic melanoma.
YERVOY® (ipilimumab) is indicated for the adjuvant
treatment of patients with cutaneous melanoma with pathologic
involvement of regional lymph nodes of more than 1 mm who have
undergone complete resection, including total lymphadenectomy.
Important Safety Information
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY (ipilimumab) 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.
Permanently discontinue YERVOY and initiate systemic
high-dose corticosteroid therapy for severe immune-mediated
reactions.
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.
Recommended Dose Modifications
Endocrine: Withhold YERVOY for systemic endocrinopathy. Resume
YERVOY in patients with complete or partial resolution of adverse
reactions (Grade 0-1) and who are receiving <7.5 mg prednisone
or equivalent per day. Permanently discontinue YERVOY for
symptomatic reactions lasting 6 weeks or longer or an inability to
reduce corticosteroid dose to 7.5 mg prednisone or equivalent per
day.
Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4
reactions not improving to Grade 1 within 2 weeks while receiving
topical therapy or requiring systemic treatment. All Other Organ
Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume
YERVOY in patients with complete or partial resolution of adverse
reactions (Grade 0-1) and who are receiving <7.5 mg prednisone
or equivalent per day. Permanently discontinue YERVOY for Grade 2
reactions lasting 6 weeks or longer, an inability to reduce
corticosteroid dose to 7.5 mg prednisone or equivalent per day, and
Grade 3 or 4 adverse reactions.
Immune-mediated Enterocolitis:
Immune-mediated enterocolitis, including fatal cases, can occur
with YERVOY. Monitor patients for signs and symptoms of
enterocolitis (such as diarrhea, abdominal pain, mucus or blood in
stool, with or without fever) and of bowel perforation (such as
peritoneal signs and ileus). In symptomatic patients, rule out
infectious etiologies and consider endoscopic evaluation for
persistent or severe symptoms. Withhold YERVOY for moderate
enterocolitis; administer anti-diarrheal treatment and, if
persistent for >1 week, initiate systemic corticosteroids (0.5
mg/kg/day prednisone or equivalent). Permanently discontinue YERVOY
in patients with severe enterocolitis and initiate systemic
corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon
improvement to ≤Grade 1, initiate corticosteroid taper and continue
over at least 1 month. In clinical trials, rapid corticosteroid
tapering resulted in recurrence or worsening symptoms of
enterocolitis in some patients. Consider adding anti-TNF or other
immunosuppressant agents for management of immune-mediated
enterocolitis unresponsive to systemic corticosteroids within 3-5
days or recurring after symptom improvement. In patients receiving
YERVOY 3 mg/kg in Trial 1, severe, life-threatening, or fatal
(diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal
signs; Grade 3-5) immune-mediated enterocolitis occurred in 34
YERVOY-treated patients (7%) and moderate (diarrhea with up to 6
stools above baseline, abdominal pain, mucus or blood in
stool; Grade 2) enterocolitis occurred in 28
YERVOY-treated patients (5%). Across all YERVOY-treated patients
(n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as
a result of complications, and 26 (5%) were hospitalized for severe
enterocolitis. Infliximab was administered to 5 (8%) of the 62
patients with moderate, severe, or life-threatening immune-mediated
enterocolitis following inadequate response to corticosteroids. In
patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-5
immune-mediated enterocolitis occurred in 76 patients (16%) and
Grade 2 enterocolitis occurred in 68 patients (14%). Seven (1.5%)
developed intestinal perforation and 3 patients (0.6%) died as a
result of complications.
Immune-mediated Hepatitis:
Immune-mediated hepatitis, including fatal cases, can occur with
YERVOY. Monitor LFTs (hepatic transaminase and bilirubin levels)
and assess patients for signs and symptoms of hepatotoxicity before
each dose of YERVOY. In patients with hepatotoxicity, rule out
infectious or malignant causes and increase frequency of LFT
monitoring until resolution. Withhold YERVOY in patients with Grade
2 hepatotoxicity. Permanently discontinue YERVOY in patients with
Grade 3-4 hepatotoxicity and administer systemic
corticosteroids (1-2 mg/kg/day of prednisone or
equivalent). When LFTs show sustained improvement or return to
baseline, initiate corticosteroid tapering and continue over 1
month. Across the clinical development program for YERVOY,
mycophenolate treatment has been administered in patients with
persistent severe hepatitis despite high-dose corticosteroids. In
patients receiving YERVOY 3 mg/kg in Trial 1, severe,
life-threatening, or fatal hepatotoxicity (AST or ALT elevations
>5× the ULN or total bilirubin elevations >3× the ULN; Grade
3-5) occurred in 8 YERVOY-treated patients (2%), with fatal hepatic
failure in 0.2% and hospitalization in 0.4%. An additional 13
patients (2.5%) experienced moderate hepatotoxicity manifested by
LFT abnormalities (AST or ALT elevations >2.5× but ≤5× the ULN
or total bilirubin elevation >1.5× but ≤3× the ULN; Grade 2). In
a dose-finding trial, Grade 3 increases in transaminases with or
without concomitant increases in total bilirubin occurred in 6 of
10 patients who received concurrent YERVOY (3 mg/kg) and
vemurafenib (960 mg BID or 720 mg BID). In patients receiving
YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated hepatitis
occurred in 51 patients (11%) and moderate Grade 2 immune-mediated
hepatitis occurred in 22 patients (5%). Liver biopsy performed in 6
patients with Grade 3-4 hepatitis showed evidence of toxic or
autoimmune hepatitis.
Immune-mediated Dermatitis:
Immune-mediated dermatitis, including fatal cases, can occur
with YERVOY. Monitor patients for signs and symptoms of dermatitis
such as rash and pruritus. Unless an alternate etiology has been
identified, signs or symptoms of dermatitis should be considered
immune-mediated. Treat mild to moderate dermatitis (e.g., localized
rash and pruritus) symptomatically; administer topical or systemic
corticosteroids if there is no improvement within 1 week. Withhold
YERVOY in patients with moderate to severe signs and symptoms.
Permanently discontinue YERVOY in patients with severe,
life-threatening, or fatal immune-mediated dermatitis (Grade 3-5).
Administer systemic corticosteroids (1-2 mg/kg/day of
prednisone or equivalent). When dermatitis is controlled,
corticosteroid tapering should occur over a period of at least 1
month. In patients receiving YERVOY 3 mg/kg in Trial 1, severe,
life-threatening, or fatal immune-mediated dermatitis (e.g.,
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
YERVOY-treated patients (2.5%); 1 patient (0.2%) died as a result
of toxic epidermal necrolysis and 1 additional patient required
hospitalization for severe dermatitis. There were 63 patients (12%)
with moderate (Grade 2) dermatitis. In patients receiving YERVOY 10
mg/kg in Trial 2, Grade 3-4 immune-mediated dermatitis occurred in
19 patients (4%). There were 99 patients (21%) with moderate Grade
2 dermatitis.
Immune-mediated Neuropathies:
Immune-mediated neuropathies, including fatal cases, can occur
with YERVOY. Monitor for symptoms of motor or sensory neuropathy
such as unilateral or bilateral weakness, sensory alterations, or
paresthesia. Withhold YERVOY in patients with moderate neuropathy
(not interfering with daily activities). Permanently discontinue
YERVOY in patients with severe neuropathy (interfering with daily
activities), such as Guillain-Barre-like syndromes. Institute
medical intervention as appropriate for management for severe
neuropathy. Consider initiation of systemic corticosteroids (1-2
mg/kg/day of prednisone or equivalent) for severe neuropathies. In
patients receiving YERVOY 3 mg/kg in Trial 1, 1 case of fatal
Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral
motor neuropathy were reported. Across the clinical development
program of YERVOY, myasthenia gravis and additional cases of
Guillain-Barré syndrome have been reported. In patients receiving
YERVOY 10 mg/kg in Trial 2, Grade 3-5 immune-mediated neuropathy
occurred in 8 patients (2%); the sole fatality was due to
complications of Guillain-Barré syndrome. Moderate Grade 2
immune-mediated neuropathy occurred in 1 patient (0.2%).
Immune-mediated Endocrinopathies:
Immune-mediated endocrinopathies, including life-threatening
cases, can occur with YERVOY. Monitor patients for clinical signs
and symptoms of hypophysitis, adrenal insufficiency (including
adrenal crisis), and hyper- or hypothyroidism. Patients may present
with fatigue, headache, mental status changes, abdominal pain,
unusual bowel habits, and hypotension, or nonspecific symptoms
which may resemble other causes such as brain metastasis or
underlying disease. Unless an alternate etiology has been
identified, signs or symptoms should be considered immune-mediated.
Monitor clinical chemistries, adrenocorticotropic hormone (ACTH)
level, and thyroid function tests at the start of treatment, before
each dose, and as clinically indicated based on symptoms. In a
limited number of patients, hypophysitis was diagnosed by imaging
studies through enlargement of the pituitary gland. Withhold YERVOY
in symptomatic patients and consider referral to an
endocrinologist. Initiate systemic corticosteroids (1-2 mg/kg/day
of prednisone or equivalent) and initiate appropriate hormone
replacement therapy. In patients receiving YERVOY 3 mg/kg in Trial
1, 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 YERVOY-treated patients (1.8%). All 9 patients had
hypopituitarism, and some had additional concomitant
endocrinopathies such as adrenal insufficiency, hypogonadism, and
hypothyroidism. Six of the 9 patients were hospitalized for severe
endocrinopathies. Moderate endocrinopathy (requiring hormone
replacement or medical intervention; Grade 2) occurred in 12
patients (2.3%) and consisted of hypothyroidism, adrenal
insufficiency, hypopituitarism, and 1 case each of hyperthyroidism
and Cushing's syndrome. The median time to onset of moderate to
severe immune-mediated endocrinopathy was 2.5 months and ranged up
to 4.4 months after the initiation of YERVOY. In patients receiving
YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated
endocrinopathies occurred in 39 patients (8%) and Grade 2
immune-mediated endocrinopathies occurred in 93 patients (20%). Of
the 39 patients with Grade 3-4 immune-mediated endocrinopathies, 35
patients had hypopituitarism (associated with 1 or more secondary
endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and
hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary
hypothyroidism. The median time to onset of Grade 3-4
immune-mediated endocrinopathy was 2.2 months (range: 2 days-8
months). Twenty-seven (69.2%) of the 39 patients were hospitalized
for immune-mediated endocrinopathies. Of the 93 patients with Grade
2 immune-mediated endocrinopathy, 74 had primary hypopituitarism
(associated with 1 or more secondary endocrinopathy, e.g., adrenal
insufficiency, hypogonadism, and hypothyroidism), 9 had primary
hypothyroidism, 3 had hyperthyroidism, 3 had thyroiditis with hypo-
or hyperthyroidism, 2 had hypogonadism, 1 had both hyperthyroidism
and hypopituitarism, and 1 subject developed Graves’
ophthalmopathy. The median time to onset of Grade 2 immune-mediated
endocrinopathy was 2.1 months (range: 9 days-19.3 months).
Other Immune-mediated Adverse Reactions, Including Ocular
Manifestations:
Permanently discontinue YERVOY for clinically significant or
severe immune-mediated adverse reactions. Initiate systemic
corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for
severe immune-mediated adverse reactions. Administer corticosteroid
eye drops for uveitis, iritis, or episcleritis. Permanently
discontinue YERVOY for immune-mediated ocular disease unresponsive
to local immunosuppressive therapy. In Trial 1, the following
clinically significant immune-mediated adverse reactions were seen
in <1% of YERVOY-treated patients: nephritis, pneumonitis,
meningitis, pericarditis, uveitis, iritis, and hemolytic anemia. In
Trial 2, the following clinically significant immune-mediated
adverse reactions were seen in <1% of YERVOY-treated patients
unless specified: eosinophilia (2.1%), pancreatitis (1.3%),
meningitis, pneumonitis, sarcoidosis, pericarditis, uveitis and
fatal myocarditis. Across 21 dose-ranging trials administering
YERVOY at doses of 0.1 to 20 mg/kg (n=2478), the following likely
immune-mediated adverse reactions were also reported with <1%
incidence: angiopathy, temporal arteritis, vasculitis, polymyalgia
rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis,
iritis, leukocytoclastic vasculitis, erythema multiforme,
psoriasis, arthritis, autoimmune thyroiditis, neurosensory
hypoacusis, autoimmune central neuropathy (encephalitis), myositis,
polymyositis, ocular myositis, hemolytic anemia, and nephritis.
Embyro-fetal Toxicity
Based on its mechanism of action, YERVOY can cause fetal harm
when administered to a pregnant woman. The effects of YERVOY are
likely to be greater during the second and third trimesters of
pregnancy. Advise pregnant women of the potential risk to a fetus.
Advise females of reproductive potential to use effective
contraception during treatment with a YERVOY-containing regimen and
for 3 months after the last dose of YERVOY.
Lactation
It is not known whether YERVOY is secreted in human milk. Advise
women to discontinue nursing during treatment with YERVOY and for 3
months following the final dose.
Common Adverse Reactions:
The most common adverse reactions (≥5%) in patients who received
YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritis
(31%), rash (29%), and colitis (8%). The most common adverse
reactions (≥5%) in patients who received YERVOY at 10 mg/kg were
rash (50%), diarrhea (49%), fatigue (46%), pruritus (45%), headache
(33%), weight loss (32%), nausea (25%), pyrexia (18%), colitis
(16%), decreased appetite (14%), vomiting (13%), and insomnia
(10%).
Please see U.S. Full Prescribing Information,
including Boxed WARNING regarding immune-mediated adverse
reactions.
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 BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
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,
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,
919-605-4521audrey.abernathy@bms.comorInvestors:Tim Power,
609-252-7509timothy.power@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.com
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