- First and only FDA-approved
combination of two Immuno-Oncology agents1
- Pivotal study CheckMate -069
demonstrates significantly superior responses and progression-free
survival with the Opdivo + Yervoy Regimen vs. Yervoy
alone1
- Approval of the Regimen marks a new
development, demonstrating the potential of targeting distinct and
complementary immune system pathways, offering patients a novel
combination treatment
Bristol-Myers Squibb Company (NYSE: BMY) today announced that
the U.S. Food and Drug Administration (FDA) approved Opdivo
(nivolumab) in combination with Yervoy (ipilimumab), for the
treatment of patients with BRAF V600 wild-type unresectable or
metastatic melanoma.1 Today’s announcement marks the first and only
FDA approval of a Regimen of two Immuno-Oncology agents in cancer.
This indication is approved under accelerated approval based on
tumor response rate and durability of response.1 Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.1
The approval is based on data from the pivotal study, CheckMate
-069, which was the first to report outcomes of the Opdivo + Yervoy
Regimen in previously untreated patients with unresectable or
metastatic melanoma. Results from the trial demonstrated a
statistically significant (p<0.001) increase in confirmed
objective response rate – the study’s primary endpoint
– in patients with BRAF wild-type melanoma treated with the
Opdivo + Yervoy Regimen [60% (95% CI: 48-71; p<0.001)] compared
to those treated with Yervoy monotherapy [11% (95% CI: 3-25)].
Complete responses were seen in 17% of patients. Partial responses
were seen in 43% of the Regimen group and 11% of the Yervoy
monotherapy group. The Opdivo + Yervoy Regimen demonstrated a 60%
reduction in the risk of progression vs. Yervoy alone (HR=0.40; 95%
CI: 0.22-0.71; p<0.002). Median PFS was 8.9 months with the
Regimen (95% CI: 7.0, NA) and 4.7 months with Yervoy alone (95% CI:
2.8-5.3).1 This trial provides clinical rationale for targeting the
immune system with two Immuno-Oncology agents in metastatic
melanoma.
Opdivo is associated with immune-mediated: pneumonitis, colitis,
hepatitis, endocrinopathies, nephritis and renal dysfunction, rash,
other adverse reactions; infusion reactions; and embryofetal
toxicity.1 Please see the Important Safety Information section
below, including Boxed WARNING for Yervoy regarding immune-mediated
adverse reactions.
“Targeting the immune system in the treatment of cancer has been
of interest to the oncology community for decades,4 and our first
Immuno-Oncology agent, Yervoy, was approved in 2011 for metastatic
melanoma. Opdivo reinforced the power of the immune system in the
fight against cancer, and is quickly becoming a foundational
component in how the oncology community treats this devastating
disease,” said Giovanni Caforio, chief executive officer,
Bristol-Myers Squibb. “Today’s approval of the Opdivo + Yervoy
Regimen marks another first for our research in Immuno-Oncology and
represents our unwavering commitment to continually redefine cancer
care, and offer patients new treatment options with the goal of
improved outcomes.”
About the Opdivo + Yervoy Regimen:
Advancing Metastatic Melanoma TreatmentCheckMate -069 is
a Phase 2, double-blind, randomized study which enrolled 140
patients with previously untreated unresectable or metastatic
melanoma,1 and included patients with both BRAF wild-type and BRAF
mutation-positive melanoma.2 The primary endpoint was objective
response rate (ORR) in patients with BRAF wild-type tumors.1
Additional efficacy outcome measures were investigator-assessed
duration of response and progression-free survival (PFS) in
patients with BRAF V600 wild-type melanoma. Randomization was
stratified by BRAF mutation status.2 The Regimen includes four
cycles of the Opdivo + Yervoy combination followed by Opdivo
monotherapy.1 In the clinical study, patients in the Opdivo +
Yervoy Regimen group received Opdivo 1mg/kg plus Yervoy 3mg/kg
every 3 weeks for 4 doses during the combination phase, followed by
Opdivo 3mg/kg every 2 weeks during the monotherapy phase. Treatment
was continued until progression or unacceptable toxicity.1 In the
Yervoy monotherapy group, patients were treated with Yervoy 3mg/kg
every 3 weeks for 4 doses with matched placebo.1 Of the 95 patients
randomized to receive the Opdivo + Yervoy Regimen, 50% were 65
years or older and 13% were 75 years or older.3 Fifty-nine percent
of patients completed all 4 doses in the initial combination phase
over a median of 9.1 weeks (range: 9.0 weeks to 26.3 weeks).1
Among patients (n=109) with BRAF wild-type melanoma, the Regimen
demonstrated a significantly superior response rate of 60% (95% CI:
48-71; p<0.001) vs. Yervoy alone, 11% (95% CI: 3-25).1 Seventeen
percent of patients experienced a complete response in the BRAF
wild-type population.1 Partial responses were seen in 43% of the
Regimen group and 11% of the Yervoy monotherapy group.1
Seventy-nine percent (34/43) of patients had ongoing responses of
at least 6 months at the time of analysis. Of these patients, 14
had a duration of response of at least 6 months but less than 9
months, and 20 patients had a duration of response of at least 9
months. The remaining 21% (9/43) of patients had a duration of
response ranging from 3 to 7 months and have progressed after
response, died, or received subsequent therapy.1 Along with higher
ORR and more complete responses, the Opdivo + Yervoy Regimen
demonstrated a 60% reduction in the risk of progression among BRAF
wild-type patients vs. Yervoy alone (HR=0.40, 95% CI: 0.22-0.71;
p<0.002).1 Median PFS was 8.9 months with the Regimen (95% CI:
7.0, NA) and 4.7 months with Yervoy alone (95% CI: 2.8-5.3).1
“Historically, metastatic melanoma has been a difficult disease
to treat.6 Now, a new treatment option based on the combination of
two valued Immuno-Oncology agents demonstrates significant efficacy
versus ipilimumab (Yervoy) in metastatic melanoma,”2 said Jedd D.
Wolchok, MD, PhD, Chief, Melanoma and Immunotherapeutics Service,
Department of Medicine and Ludwig Center at Memorial Sloan
Kettering Cancer Center. “Today’s approval represents a step
forward for the melanoma community, providing hope for patients
with metastatic melanoma.”
In CheckMate -069, serious adverse reactions (62% vs. 39%),
adverse reactions leading to permanent discontinuation (43% vs.
11%) or dose delays (47% vs. 22%), and Grade 3 or 4 adverse
reactions (69% vs. 43%) all occurred more frequently in patients
receiving the Opdivo + Yervoy Regimen compared with those receiving
Yervoy alone. In the Opdivo + Yervoy Regimen group, 27% (25/94) of
patients did not complete all four cycles of the Opdivo + Yervoy
Regimen. The first occurrence of a Grade 3 or 4 adverse reaction
was during administration of the Opdivo + Yervoy Regimen in 56
patients (59%), while 9 patients (10%) experienced first occurrence
of a Grade 3 or 4 adverse reaction during administration of Opdivo
alone.
The most common adverse reactions leading to discontinuation of
Opdivo, as compared to Yervoy alone, were colitis (16% vs. 2%),
diarrhea not treated with corticosteroids (4% vs. 4%), increased
ALT levels (4% vs. 0), pneumonitis (3% vs. 0), and AST increase (3%
vs. 0). The most frequent serious adverse events with the Opdivo +
Yervoy Regimen, as compared to Yervoy alone, were colitis (17% vs.
9%), diarrhea (9% vs. 7%), pyrexia (6% vs. 7%), and pneumonitis (5%
vs. 0). The most common adverse reactions (≥20%) reported in
patients receiving the Opdivo + Yervoy Regimen 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%).
“We are currently witnessing a turning point in cancer history,
based on the significant impact Immuno-Oncology is making in the
lives of patients with metastatic melanoma. Today’s approval of the
first Regimen of two Immuno-Oncology agents, Opdivo and Yervoy, is
an exciting moment for our community because it reinforces we are
on a positive path forward, providing new approaches which
translate into meaningful results for patients,” said Tim Turnham,
Executive Director, Melanoma Research Foundation.
About the Opdivo + Yervoy
RegimenThe scientific rationale for targeting the immune
system via dual immune checkpoint inhibition in cancer has formed
the basis of a novel approach to the treatment of metastatic
melanoma.4
“At Bristol-Myers Squibb, we have been at the forefront of
researching the potential of two different immune checkpoint
pathways – CTLA-4 and PD-1 – in the treatment of cancer,” said
Francis Cuss, MB BChir, FRCP, executive vice president and chief
scientific officer, Bristol-Myers Squibb. “From initial
pre-clinical research, to pivotal studies resulting in regulatory
approval of Yervoy and Opdivo as monotherapies, to today’s FDA
approval, we are proud to be leading the way in bringing a dual
Immuno-Oncology Regimen to cancer patients for the first time.”
Cancer cells may exploit “regulatory” pathways, such as
checkpoint pathways, to hide from the immune system and shield the
tumor from immune attack.4 Opdivo and Yervoy are immune
checkpoint inhibitors that target separate, distinct and
complementary checkpoint pathways (PD-1 and CTLA-4).4 The mechanism
of action involves dual immune checkpoint inhibition resulting in
increased anti-tumor activity.5 Yervoy blockade of CTLA-4 has been
shown to augment T-cell activation and proliferation,4 while Opdivo
restores the active T-cell response directed at the tumor.4 This
may affect healthy cells and result in immune-mediated adverse
reactions, which can be severe and potentially fatal.4
Opdivo is a programmed death-1 (PD-1) immune checkpoint
inhibitor that has received approval from the FDA in other
indications, including metastatic squamous non-small cell lung
cancer (NSCLC) with progression on or after platinum-based
chemotherapy.
Bristol-Myers Squibb has a broad, global development program to
study the combination of Opdivo and Yervoy consisting of more than
14 trials in which more than 2,000 patients have been enrolled
worldwide through September 2015.
About Metastatic
MelanomaMelanoma is a form of skin cancer characterized
by the uncontrolled growth of pigment-producing cells (melanocytes)
located in the skin.6 Metastatic melanoma is the deadliest form of
the disease, and occurs when cancer spreads beyond the surface of
the skin to other organs.6 The incidence of melanoma has been
increasing for at least 30 years.6 An estimated 73,870 melanoma
cases will be diagnosed in the U.S. in 2015.6 Melanoma is mostly
curable when treated in its early stages.6 However, in its late
stages, 5-year and 10-year survival rates in the U.S. average
15-20% and 10-15%, respectively.6
About Bristol-Myers Squibb’s Patient
Support ProgramsBristol-Myers Squibb remains committed
to helping patients access our medicines. For support and
assistance, patients and physicians may call 1-855-OPDIVO-1. This
number offers one-stop access to a range of support services for
patients and healthcare professionals alike.
About Bristol-Myers Squibb’s Access
SupportBristol-Myers Squibb is committed to helping
patients access the Opdivo + Yervoy Regimen and offers BMS Access
Support® to support patients and providers in gaining access. BMS
Access Support, the Bristol-Myers Squibb Reimbursement Services
program, is designed to support access to BMS medicines and
expedite time to therapy through reimbursement support including
Benefit Investigations, Prior Authorization Facilitation, Appeals
Assistance, and assistance for patient out-of-pocket costs. BMS
Access Support assists patients and providers throughout the
treatment journey – whether it is at initial diagnosis or in
support of transition from a clinical trial. More information about
our reimbursement support services can be obtained by calling
1-800-861-0048 or by visiting www.bmsaccesssupport.com. For
healthcare providers seeking specific reimbursement information,
please visit the BMS Access Support Product section by visiting
www.bmsaccesssupportopdivo.com.
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 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 in 0.7% (5/691) of patients receiving OPDIVO
as a single agent; no cases occurred in Checkmate 063. In Checkmate
063, immune-mediated pneumonitis occurred in 6% (7/117) of patients
receiving OPDIVO as a single agent including five Grade 3 and two
Grade 2 cases. Across the clinical trial experience in 188 patients
with melanoma who received OPDIVO in combination with YERVOY, in
Checkmate 069 (n=94) and an additional dose-finding study (n=94),
fatal immune-mediated pneumonitis occurred in 0.5% (1/188) of
patients. In Checkmate 069, there were six additional 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 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 063, diarrhea occurred
in 21% (24/117) of patients receiving OPDIVO as a single agent.
Grade 3 immune-mediated colitis occurred in 0.9% (1/117) of
patients. 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 YERVOY Phase 3 study, 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 063, the incidences of increased liver test values were
AST (16%), alkaline phosphatase (14%), ALT (12%), and total
bilirubin (2.7%) in patients receiving OPDIVO as a single agent. 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 YERVOY Phase 3 study, 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 YERVOY Phase 3 study, 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 YERVOY Phase 3 study, 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, and thyroid disorders can
occur with OPDIVO treatment. Monitor patients for signs and
symptoms of hypophysitis, signs and symptoms of adrenal
insufficiency during and after treatment, and thyroid function
prior to and periodically during treatment. 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.
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 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 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 063, hypothyroidism occurred in 4.3% (5/117) of patients
receiving OPDIVO as a single agent. Hyperthyroidism occurred in
1.7% (2/117) of patients, including one Grade 2 case.
In a separate YERVOY Phase 3 study, 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 063, the incidence of
elevated creatinine was 22%. Immune-mediated renal dysfunction
(Grade 2) occurred in 0.9% (1/117) of patients receiving OPDIVO as
a single agent. 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. Monitor
patients for rash. Administer corticosteroids for Grade 3 or 4
rash. Withhold for Grade 3 and permanently discontinue for Grade 4.
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).
Other Immune-Mediated Adverse Reactions
Based on the severity of adverse reaction, permanently
discontinue or withhold treatment, administer high-dose
corticosteroids, and, if appropriate, initiate hormone-replacement
therapy. In Checkmate 063, the following clinically significant
immune-mediated adverse reactions occurred in <2% of
single-agent OPDIVO-treated patients: uveitis, pancreatitis, facial
and abducens nerve paresis, demyelination, autoimmune neuropathy,
motor dysfunction, and vasculitis. 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: diabetes mellitus, diabetic
ketoacidosis, and myasthenic syndrome. In Checkmate 069, the
following additional immune-mediated adverse reactions occurred in
1% of patients treated with OPDIVO in combination with YERVOY:
Guillain-Barré syndrome and hypopituitarism. Across clinical trials
of OPDIVO in combination with YERVOY, the following additional
clinically significant, immune-mediated adverse reactions were
identified: uveitis, sarcoidosis, duodenitis, pancreatitis, and
gastritis.
Infusion Reactions
Severe infusion reactions have been reported in <1% of
patients in clinical trials of OPDIVO. In Checkmate 069, Grade 2
infusion reactions occurred in 3% (3/94) patients receiving OPDIVO
in combination with YERVOY. Discontinue OPDIVO in patients with
severe or life-threatening infusion reactions. Interrupt or slow
the rate of infusion in patients with mild or moderate infusion
reactions.
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-containing regimen and for at least 5 months after the last
dose of OPDIVO.
Lactation
It is not known whether OPDIVO is present in human milk. Because
many drugs, including antibodies, are excreted in human milk and
because of the potential for serious adverse reactions in nursing
infants from OPDIVO-containing regimen, advise women to discontinue
breastfeeding during treatment.
Serious Adverse Reactions
In Checkmate 063, serious adverse reactions occurred in 59% of
patients receiving OPDIVO as a single agent. 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.
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 063, the most common adverse reactions (≥20%)
reported with OPDIVO as a single agent were fatigue (50%), dyspnea
(38%), musculoskeletal pain (36%), decreased appetite (35%), cough
(32%), nausea (29%), and constipation (24%). 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 YERVOY Phase 3 study, 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 CollaborationIn 2011, through a
collaboration agreement with Ono Pharmaceutical, Bristol-Myers
Squibb expanded its territorial rights to develop and
commercialize nivolumab 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
SquibbBristol-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
StatementThis 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 Opdivo + Yervoy
Regimen will become a commercially successful product.
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.
###
References
1 Opdivo U.S. Product Information. Last updated: September 30,
2015.
2 New England Journal of Medicine. “Nivolumab and Ipilimumab
versus Ipilimumab in Untreated Melanoma” Available at
http://www.nejm.org/doi/full/10.1056/NEJMoa1414428. Accessed on
September 23, 2015.
3 Bristol-Myers Squibb Data on File.
4 American Cancer Society. “Cancer Immunotherapy.” Available at
http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/immunotherapy/index.
Accessed on September 23, 2015.
5 Nature Reviews Cancer. “The Blockade of Immune Checkpoints in
Cancer Immunotherapy.” Available at
http://www.nature.com/nrc/journal/v12/n4/full/nrc3239.html.
Accessed on September 24, 2015.
6American Cancer Society. “Melanoma.” Available at
http://www.cancer.org/cancer/skincancer-melanoma/index. Accessed on
September 23, 2015.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151001005768/en/
Media Inquiries:Carrie Fernandez, 609-419-5448Cell:
215-859-2605carrie.fernandez@bms.comorInvestors:Ranya
Dajani, 609-252-5330Cell: 215-666-1515ranya.dajani@bms.comorBill
Szablewski, 609-252-5864william.szablewski@bms.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Sep 2023 to Sep 2024