[April 20, 2015] |
|
First Randomized Study Evaluating Opdivo (nivolumab)+Yervoy (ipilimumab) Regimen Demonstrates Superior Efficacy Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma
Bristol-Myers
Squibb Company (NYSE:BMY) today announced positive results from a
Phase II trial (CheckMate -069), evaluating the Opdivo
(nivolumab)+Yervoy (ipilimumab) regimen versus Yervoy
alone in patients with previously untreated advanced melanoma. Patients
with BRAF wild-type mutation status treated with the Opdivo+Yervoy
regimen experienced a higher objective response rate (ORR) of 61%
(n=44/72) - the primary study endpoint - compared to 11% (n=4/37) for
patients administered Yervoy monotherapy (P<0.001). Complete
responses were also reported in 22% (n=16) of patients with BRAF
wild-type mutation status administered the Opdivo+Yervoy regimen
and in no patients who received Yervoy monotherapy. Similar
results were also observed in BRAF mutation-positive patients. The
safety profile was consistent with previously-reported studies
evaluating the Opdivo+Yervoy regimen and included grade 3-4
colitis (17%), diarrhea (11%), and increased alanine aminotransferase
(11%).
These data will be presented today at the American Association for
Cancer Research (AACR) Annual Meeting and featured during a press
briefing at 8:30 AM EDT [Abstract #2860]. The results will also be
published in The New England Journal of Medicine (NEJM).
"These data are unprecedented in advanced melanoma, showing efficacy
results that have not previously been observed with Immuno-Oncology
agents," said F. Stephen Hodi, M.D., Associate Professor of Medicine,
Dana-Farber Cancer Institute and an author of the NEJM
manuscript. "With the Opdivo+Yervoy regimen, we observed
much higher response rates which were sustained, as well as significant
reduction in tumor burden than with Yervoy. These responses seen
in CheckMate -069 demonstrate the potential of this regimen in patients
with metastatic melanoma."
Melanoma is the most serious form of skin cancer and strikes adults of
all ages. While melanoma represents less than 5% of skin cancers, it
results in most deaths. The CheckMate -069 trial is the first randomized
study reporting outcomes in the first-line setting for advanced melanoma
patients treated with a regimen of immune checkpoint inhibitors compared
to Yervoy. The efficacy and safety results of CheckMate -069 are
consistent with the Phase Ib dose-ranging trial (CheckMate -004), which
evaluated the safety and activity of the regimen in patients with
advanced melanoma.
"The CheckMate -069 results reinforce our belief that the future lies in
the combination of Immuno-Oncology agents, including Opdivo and Yervoy,
that can leverage the immune system in order to offer cancer
patients options with greater efficacy beyond current treatment
approaches," said Michael Giordano, senior vice president, Head of
Development, Oncology. "Our strategy has always been to build upon the
success achieved with Yervoy. In 2011, long-term survival for
metastatic melanoma patients was unheard of, but the introduction of Yervoy
has helped to make this a reality for some patients. Now we are building
on this success with Opdivo, which was the first PD-1 inhibitor
to demonstrate an improved survival benefit."
About CheckMate -069
CheckMate -069 is a Phase II double-blind, randomized study that
evaluated the Opdivo+Yervoy regimen in patients with previously
untreated unresectable Stage 3 and 4 melanoma. The study included
patients with both BRAF wild-type and BRAF mutation-positive melanoma.
The trial enrolled 142 patients who were randomized to receive either
the Opdivo+Yervoy (n=95) regimen or Yervoy (n=47)
monotherapy. Randomization was stratified by BRAF mutation status
(V600 wild-type tumors versus BRAF mutation-positive tumors as assessed
by an FDA-approved test). Patients in the Opdivo+Yervoy regimen
group received 1 mg/kg of Opdivo plus 3 mg/kg of Yervoy
every 3 weeks for 4 doses followed by 3 mg/kg of Opdivo per every
2 weeks until progression or unacceptable toxic effects. In the Yervoy
monotherapy group, patients were treated with the same dosing schedule
plus matching placebo.
The primary endpoint was ORR in patients with BRAF wild-type tumors.
Secondary endpoints included progression-free survival (PFS) in BRAF
wild type patients and ORR and PFS in BRAF V600 mutation-positive
patients, along with safety.
Along with higher ORR and more complete responses, the regimen decreased
risk of progression for BRAF mutant and wild-type patients (hazard
ratios = 0.4 [95% CI: 0.23, 0.68; P<0.001] and 0.38 [95% CI: 0.15,
1.00], respectively), representing a 60-62% reduction of risk of
progression or death. In BRAF wild-type patients, median PFS was not
reached. In BRAF mutation-positive patients, median PFS was 8.5 months
for the regimen and 2.7 months for Yervoy alone. In addition, ORR
was independent of PD-L1 status: 58% among patients with PD-L1 positive
tumors and 55% among those with and PD-L1 negative tumors. The minimum
follow-up period after randomization was 11 months.
CheckMate -069 is the first randomized study to characterize the safety
profile of the Opdivo+Yervoy regimen versus Yervoy
monotherapy. The safety profile was consistent with that previously
reported for the Opdivo+Yervoy regimen. The treatment-related
adverse event rate was similar (91% for the Opdivo+Yervoy regimen
versus 93% for Yervoy monotherapy). The incidence of grade 3/4
adverse events (drug-related AEs) was higher with the Opdivo+Yervoy
regimen (54%) compared to 24% of patients who received Yervoy
monotherapy and managed using established safety guidelines and the
majority (approximately 80%) improved or resolved with appropriate
monitoring and use of corticosteroids. The most common grade 3/4 AEs
with the Opdivo+Yervoy regimen were colitis (17%), diarrhea
(11%), and increased alanine aminotransferase (11%). The Opdivo+Yervoy
regimen was discontinued due to adverse events in 47% of patients versus
17% for Yervoy monotherapy. Of those patients who discontinued
due to adverse events, 68% continued to experience a complete or partial
response. There were three drug-related deaths associated with the Opdivo+Yervoy
regimen.
About Opdivo and Yervoy
Cancer cells may exploit "regulatory" pathways, such as checkpoint
pathways, to hide from the immune system and shield the tumor from
immune attack. Opdivo and Yervoy are both monoclonal
antibodies and immune checkpoint inhibitors that target separate,
distinct checkpoint pathways. Inhibition of these immune checkpoint
pathways results in enhanced T cell function greater than the effects of
either antibody alone.
Opdivo became the first PD-1 immune checkpoint inhibitor to
receive regulatory approval anywhere in the world on July 4, 2014 when
Ono Pharmaceutical Co. announced that it received manufacturing and
marketing approval in Japan for the treatment of patients with
unresectable melanoma. In the U.S., the U.S. Food and Drug
Administration (FDA) granted its first approval for Opdivo for
the treatment of patients with unresectable or metastatic melanoma and
disease progression following Yervoy (ipilimumab) and, if
BRAF V600 mutation positive, a BRAF inhibitor. Recently, on March 5,
2015, Opdivo received its second FDA approval for the treatment
of patients with metastatic squamous non-small cell lung cancer (NSCLC)
with progression on or after platinum-based chemotherapy.
In the European Union, the European Medicines Agency (EMA (News - Alert)) has validated
for review the Marketing Authorization Application for Opdivo in
advanced melanoma. The application has also been granted accelerated
assessment by the EMA's Committee for Medicinal Products for Human Use
(CHMP). The EMA also validated for review the MAA for Opdivo in
NSCLC.
On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy
for patients with unresectable or metastatic melanoma. Yervoy is
now approved in more than 40 countries.
Bristol-Myers Squibb has a broad, global development program to study Opdivo
in multiple tumor types consisting of more than 50 trials - as
monotherapy or in combination with other therapies - in which more than
7,000 patients have been enrolled worldwide.
OPDIVO (nivolumab) IMPORTANT SAFETY INFORMATION
Immune-Mediated Pneumonitis
-
Severe pneumonitis or interstitial lung disease, including fatal
cases, occurred with OPDIVO treatment. Across the clinical trial
experience in 691 patients with solid tumors, fatal immune-mediated
pneumonitis occurred in 0.7% (5/691) of patients receiving OPDIVO; no
cases occurred in Trial 3. In Trial 3, immune-mediated pneumonitis
occurred in 6% (7/117) of patients receiving OPDIVO including five
Grade 3 and two Grade 2 cases. Monitor patients for signs and symptoms
of pneumonitis. Administer corticosteroids for Grade 2 or greater
pneumonitis. Permanently discontinue OPDIVO for Grade 3 or 4 and
withhold OPDIVO until resolution for Grade 2.
Immune-Mediated Colitis
-
In Trial 3, diarrhea occurred in 21% (24/117) of patients receiving
OPDIVO. Grade 3 immune-mediated colitis occurred in 0.9% (1/117) of
patients. Monitor patients for immune-mediated colitis. Administer
corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4
colitis. Withhold OPDIVO for Grade 2 or 3. Permanently discontinue
OPDIVO for Grade 4 colitis or recurrent colitis upon restarting OPDIVO.
Immune-Mediated Hepatitis
-
In Trial 3, the incidences of increased liver test values were AST
(16%), alkaline phosphatase (14%), ALT (12%), and total bilirubin
(2.7%). Monitor patients for abnormal liver tests prior to and
periodically during treatment. Administer corticosteroids for Grade 2
or greater transaminase elevations. Withhold OPDIVO for Grade 2 and
permanently discontinue OPDIVO for Grade 3 or 4 immune-mediated
hepatitis.
Immune-Mediated Nephritis and Renal Dysfunction
-
In Trial 3, the incidence of elevated creatinine was 22%.
Immune-mediated renal dysfunction (Grade 2) occurred in 0.9% (1/117)
of patients. Monitor patients for elevated serum creatinine prior to
and periodically during treatment. For Grade 2 or 3 serum creatinine
elevation, withhold OPDIVO and administer corticosteroids; if
worsening or no improvement occurs, permanently discontinue OPDIVO.
Administer corticosteroids for Grade 4 serum creatinine elevation and
permanently discontinue OPDIVO.
Immune-Mediated Hypothyroidism and Hyperthyroidism
-
In Trial 3, hypothyroidism occurred in 4.3% (5/117) of patients
receiving OPDIVO. Hyperthyroidism occurred in 1.7% (2/117) of patients
including one Grade 2 case. Monitor thyroid function prior to and
periodically during treatment. Administer hormone replacement therapy
for hypothyroidism. Initiate medical management for control of
hyperthyroidism.
Other Immune-Mediated Adverse Reactions
-
The following clinically significant immune-mediated adverse reactions
occurred in <2% of OPDIVO-treated patients: adrenal insufficiency,
uveitis, pancreatitis, facial and abducens nerve paresis,
demyeliniation, autoimmune neuropathy, motor dysfunction and
vasculitis. Across clinical trials of OPDIVO administered at doses 3
mg/kg and 10 mg/kg, additional clinically significant, immune-mediated
adverse reactions were identified: hypophysitis, diabetic
ketoacidosis, hypopituitarism, Guillain-Barré syndrome, and myasthenic
syndrome. Based on the severity of adverse reaction, withhold OPDIVO,
administer high-dose corticosteroids, and, if appropriate, initiate
hormone- replacement therapy.
Embryofetal 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 OPDIVO 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
OPDIVO, advise women to discontinue breastfeeding during treatment.
Serious Adverse Reactions
-
In Trial 3, serious adverse reactions occurred in 59% of patients
receiving OPDIVO. The most frequent serious adverse drug reactions
reported in =2% of patients were dyspnea, pneumonia, chronic
obstructive pulmonary disease exacerbation, pneumonitis,
hypercalcemia, pleural effusion, hemoptysis, and pain.
Common Adverse Reactions
-
The most common adverse reactions (=20%) reported with OPDIVO in Trial
3 were fatigue (50%), dyspnea (38%), musculoskeletal pain (36%),
decreased appetite (35%), cough (32%), nausea (29%), and constipation
(24%).
Please see U.S. Full Prescribing Information for OPDIVO here.
YERVOY® (ipilimumab) INDICATION & IMPORTANT
SAFETY INFORMATION
YERVOY (ipilimumab) is indicated for the treatment of unresectable or
metastatic melanoma.
Important Safety Information
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse
reactions due to T-cell activation and proliferation. 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) and thyroid function tests at
baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic high-dose
corticosteroids for severe immune-mediated reactions.
Recommended Dose Modifications
Withhold dose for any moderate immune-mediated adverse reactions or for
symptomatic endocrinopathy until return to baseline, improvement to mild
severity, or complete resolution, and patient is receiving <7.5 mg
prednisone or equivalent per day.
Permanently discontinue YERVOY for any of the following:
-
Persistent moderate adverse reactions or inability to reduce
corticosteroid dose to 7.5 mg prednisone or equivalent per day
-
Failure to complete full treatment course within 16 weeks from
administration of first dose
-
Severe or life-threatening adverse reactions, including any of the
following:
-
Colitis with abdominal pain, fever, ileus, or peritoneal signs;
increase in stool frequency (=7 over baseline), stool
incontinence, need for intravenous hydration for >24 hours,
gastrointestinal hemorrhage, and gastrointestinal perforation
-
AST or ALT >5 × the upper limit of normal (ULN) or total bilirubin
>3 × the ULN
-
Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash
complicated by full-thickness dermal ulceration or necrotic,
bullous, or hemorrhagic manifestations
-
Severe motor or sensory neuropathy, Guillain-Barré syndrome, or
myasthenia gravis
-
Severe immune-mediated reactions involving any organ system
-
Immune-mediated ocular disease which is unresponsive to topical
immunosuppressive therapy
Immune-mediated Enterocolitis:
-
In the pivotal Phase 3 study in YERVOY-treated patients, 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%) and moderate (diarrhea with up to 6
stools above baseline, abdominal pain, mucus or blood in stool; Grade
2) enterocolitis occurred in 28 (5%) patients
-
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 of 62 (8%) patients with moderate,
severe, or life-threatening immune-mediated enterocolitis following
inadequate response to corticosteroids
-
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
-
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
-
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)
Immune-mediated Hepatitis:
-
In the pivotal Phase 3 study in YERVOY-treated patients, 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%
-
13 (2.5%) additional YERVOY-treated patients experienced moderate
hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations
>2.5x but =5x the ULN or total bilirubin elevation >1.5x but =3x the
ULN; Grade 2)
-
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
-
Permanently discontinue YERVOY in patients with Grade 3-5
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
-
Withhold YERVOY in patients with Grade 2 hepatotoxicity
-
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)
Immune-mediated Dermatitis:
-
In the pivotal Phase 3 study in YERVOY-treated patients, 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 (2.5%)
patients
-
1 (0.2%) patient died as a result of toxic epidermal necrolysis
-
1 additional patient required hospitalization for severe dermatitis
-
There were 63 (12%) YERVOY-treated patients with moderate (Grade 2)
dermatitis
-
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
-
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. Withhold YERVOY in
patients with moderate to severe signs and symptoms
-
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
Immune-mediated Neuropathies:
-
In the pivotal Phase 3 study in YERVOY-treated patients, 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
-
Monitor for symptoms of motor or sensory neuropathy such as unilateral
or bilateral weakness, sensory alterations, or paresthesia.
Permanently discontinue YERVOY in patients with severe neuropathy
(interfering with daily activities) such as Guillain-Barré-like
syndromes
-
Institute medical intervention as appropriate for management of severe
neuropathy. Consider initiation of systemic corticosteroids (1-2
mg/kg/day of prednisone or equivalent) for severe neuropathies.
Withhold YERVOY in patients with moderate neuropathy (not interfering
with daily activities)
Immune-mediated Endocrinopathies:
-
In the pivotal Phase 3 study in YERVOY- treated patients, 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
-
Moderate endocrinopathy (requiring hormone replacement or medical
intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients
and consisted of hypothyroidism, adrenal insufficiency,
hypopituitarism, and 1 case each of hyperthyroidism and Cushing's
syndrome
-
Median time to onset of moderate to severe immune-mediated
endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the
initiation of 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 thyroid function tests and clinical chemistries 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. Initiate systemic
corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and
initiate appropriate hormone replacement therapy. Long-term hormone
replacement therapy may be necessary
Other Immune-mediated Adverse Reactions, Including Ocular
Manifestations:
-
In the pivotal Phase 3 study in YERVOY-treated patients, clinically
significant immune-mediated adverse reactions seen in <1% were:
nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and
hemolytic anemia
-
Across the clinical development program for YERVOY, likely
immune-mediated adverse reactions also reported with <1% incidence
were: myocarditis, angiopathy, temporal arteritis, vasculitis,
polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis,
scleritis, leukocytoclastic vasculitis, erythema multiforme,
psoriasis, pancreatitis, arthritis, autoimmune thyroiditis,
sarcoidosis, neurosensory hypoacusis, autoimmune central neuropathy
(encephalitis), myositis, polymyositis, and ocular myositis
-
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
Pregnancy & Nursing:
-
YERVOY is classified as pregnancy category C. There are no adequate
and well-controlled studies of YERVOY in pregnant women. Use YERVOY
during pregnancy only if the potential benefit justifies the potential
risk to the fetus
-
Human IgG1 is known to cross the placental barrier and YERVOY is an
IgG1; therefore, YERVOY has the potential to be transmitted from the
mother to the developing fetus
-
It is not known whether YERVOY is secreted in human milk. Because many
drugs are secreted in human milk and because of the potential for
serious adverse reactions in nursing infants from YERVOY, a decision
should be made whether to discontinue nursing or to discontinue YERVOY
Common Adverse Reactions:
-
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 Full Prescribing Information, including Boxed WARNING
regarding immune-mediated adverse reactions, available at www.bms.com.
Yervoy is a registered trademark of Bristol-Myers Squibb Company.
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. The
incidence of melanoma has been increasing for at least 30 years. In
2015, an estimated 73,870 melanoma cases will be diagnosed in the U.S.
Melanoma is mostly curable when treated in its early stages. However, in
its late stages, the average survival rate is just 6 months with a
1-year survival of 25.5%, making it one of the most aggressive forms of
cancer.
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.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical company whose mission is
to discover, develop and deliver innovative medicines that help patients
prevail over serious diseases. For more information about Bristol-Myers
Squibb, visit www.bms.com,
or follow us on Twitter (News - Alert) at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be guaranteed.
Among other risks, there can be no guarantee that the combination
treatment of Opdivo and Yervoy will receive regulatory approval or, if
approved, that it will become a commercially successful regimen.
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.
[ Back To TMCnet.com's Homepage ]
|