Approval is based on the CheckMate-77T
trial, in which the Opdivo-based regimen demonstrated significantly
longer event-free survival compared to the chemotherapy and placebo
arm; a high pathologic complete response rate was also
observed1
Opdivo is the only approved PD-1 inhibitor
for resectable NSCLC in both a neoadjuvant-only regimen and as part
of a perioperative treatment regimen1
This milestone adds to Bristol Myers
Squibb’s thoracic portfolio and highlights the company’s commitment
to advancing treatments for patients with early-stage
disease
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S.
Food and Drug Administration (FDA) approved Opdivo® (nivolumab) for
the treatment of adult patients with resectable (tumors ≥4 cm or
node positive) non-small cell lung cancer (NSCLC) and no known
epidermal growth factor receptor (EGFR) mutations or
anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant
treatment, in combination with platinum-doublet chemotherapy,
followed by single-agent Opdivo as adjuvant treatment after surgery
– otherwise referred to as perioperative therapy, which is used
before and after surgery.1 The approval is based on results from
the CheckMate-77T trial, the company’s second positive Phase 3
randomized trial with an immunotherapy-based combination for the
treatment of resectable NSCLC.1 Opdivo is now the only PD-1
inhibitor to demonstrate statistically significant and clinically
meaningful benefits in this disease versus chemotherapy in both a
neoadjuvant-only regimen and as part of a perioperative
regimen.1
“Given the rates of disease recurrence in patients with
resectable NSCLC, there is a clear need for options that can be
administered before and after surgery that may target
micrometastasis, help reduce the risk of cancer returning and
improve the chance of successful surgical treatment,” said Tina
Cascone, MD, PhD, associate professor of Thoracic/Head and Neck
Medical Oncology at The University of Texas MD Anderson Cancer
Center.2,3,4 “This approval is a step forward for patients with
resectable disease, as the perioperative nivolumab plus neoadjuvant
chemotherapy regimen can offer an improved event free survival
(EFS) compared with neoadjuvant chemotherapy alone and has the
potential for achieving a pathologic response (pCR) in one in four
patients.”2
The CheckMate-77T trial evaluated the perioperative regimen of
neoadjuvant Opdivo with platinum-doublet chemotherapy followed by
surgery and adjuvant Opdivo monotherapy (n=229), compared to
neoadjuvant platinum-doublet chemotherapy and placebo followed by
surgery and adjuvant placebo (n=232) in adult patients with
resectable NSCLC.2 In the trial, the Opdivo arm improved EFS, a
primary endpoint, compared to the chemotherapy and placebo
treatment arm.2 A high pCR rate was also observed as one of the
pre-specified secondary endpoints.2
The risk of disease recurrence, progression or death was reduced
by 42% (EFS Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]:
0.43 to 0.78; P=0.00025) in patients treated in the Opdivo arm,
compared to the chemotherapy and placebo arm, with a median
follow-up of 25.4 months.2 In addition, 18-month EFS was
demonstrated in 70% of patients in the Opdivo arm, compared to 50%
of patients in the chemotherapy and placebo arm.2 Furthermore, 25%
of patients in the Opdivo arm achieved pCR, while 4.7% of patients
in the comparator arm achieved pCR in the intent-to-treat
population (estimated treatment difference of 20.5%; 95% CI,14.3 to
26.6).2
Opdivo is associated with the following Warnings &
Precautions: severe and fatal immune-mediated adverse reactions,
including pneumonitis, colitis, hepatitis and hepatotoxicity,
endocrinopathies, dermatologic adverse reactions, nephritis and
renal dysfunction; infusion-related reactions; complications of
allogeneic hematopoietic stem cell transplantation (HSCT);
embryo-fetal toxicity.1 Treatment of patients with multiple myeloma
with a PD-1 or PD-L1 blocking antibody in combination with a
thalidomide analogue and dexamethasone is not recommended outside
of controlled clinical trials.1 Please see Important Safety
Information below.
“This milestone expands the role of Opdivo-based treatments and
builds upon the foundation set by the FDA approval of
neoadjuvant-only Opdivo plus chemotherapy in resectable NSCLC based
on the CheckMate-816 trial,” said Wendy Short Bartie, senior vice
president of U.S. Oncology and Hematology at Bristol Myers Squibb.1
“With this new Opdivo-based regimen, we are reinforcing our
commitment to helping improve patient outcomes and expanding our
thoracic portfolio in early-stage disease.”
The recommended dose for Opdivo in this indication is 360 mg
with platinum-doublet chemotherapy on the same day every three
weeks for up to four cycles or until disease progression or
unacceptable toxicity, then continued as a single-agent Opdivo 480
mg every four weeks after surgery for up to 13 cycles
(approximately one year) or until disease recurrence or
unacceptable toxicity.1 The FDA previously approved Opdivo for
adult patients with resectable (tumors ≥4 cm or node positive)
NSCLC in the neoadjuvant setting, in combination with
platinum-doublet chemotherapy.1 Opdivo and Opdivo-based
combinations have been approved by the FDA in the neoadjuvant,
adjuvant or perioperative settings across four cancers to date,
including lung cancer, melanoma, bladder cancer and
esophageal/gastroesophageal junction cancer.1
About CheckMate-77T
CheckMate-77T is a Phase 3 randomized, double-blind,
multi-center trial evaluating neoadjuvant Opdivo in combination
with platinum-doublet chemotherapy followed by surgery and
single-agent adjuvant Opdivo, compared to neoadjuvant
platinum-doublet chemotherapy and placebo followed by surgery and
adjuvant placebo in patients with resectable NSCLC.5
In the CheckMate-77T study, a total of 461 patients were
randomized to receive either neoadjuvant Opdivo 360 mg with
platinum-doublet chemotherapy every three weeks, or placebo and
platinum-doublet chemotherapy every three weeks, until disease
progression or unacceptable toxicity, for up to four cycles,
followed by single-agent Opdivo 480 mg after surgery every four
weeks or placebo every four weeks, until disease progression or
unacceptable toxicity, for up to thirteen cycles (approximately one
year).1 The primary endpoint of the trial is event-free survival
determined by Blinded Independent Central Review (BICR). Secondary
endpoints of the trial include pathologic complete response and
major pathologic response, both determined by Blinded Independent
Pathological Review (BIPR), as well as overall survival and
safety.2
Select Safety Profile from
CheckMate-77T
The most common adverse reactions (reported in ≥20%) in patients
receiving Opdivo in combination with chemotherapy (n= 228) were
anemia (39.5%), constipation (32.0%), nausea (28.9%), fatigue
(28.1%), alopecia (25.9%), and cough (21.9%).6
Serious adverse reactions occurred in 21% of patients who
received Opdivo in combination with platinum-doublet chemotherapy
as neoadjuvant treatment (n=228).1 The most frequent (≥2%) serious
adverse reaction was pneumonia.1 Fatal adverse reactions occurred
in 2.2% of patients, due to cerebrovascular accident, COVID-19
infection, hemoptysis, pneumonia, and pneumonitis (0.4% each).1
In Checkmate 77T, 5.3% (n=12) of the OPDIVO-treated patients who
received neoadjuvant treatment, did not receive surgery due to
adverse reactions. The adverse reactions that led to cancellation
of surgery in OPDIVO-treated patients were cerebrovascular
accident, pneumonia, and colitis/diarrhea (2 patients each) and
acute coronary syndrome, myocarditis, hemoptysis, pneumonitis,
COVID-19, and myositis (1 patient each).
Serious adverse reactions occurred in 22% of the patients who
received single-agent Opdivo as adjuvant treatment (n=142).1 The
most frequent serious adverse reaction was pneumonitis/ILD (2.8%).1
One fatal adverse event due to COVID-19 occurred.1 The
perioperative regimen had a safety profile consistent with
previously reported Opdivo studies in NSCLC and no new safety
signals were identified.2
About Lung Cancer
Lung cancer is the leading cause of cancer deaths in the United
States.7 The two main types of lung cancer are non-small cell and
small cell.7 Non-small cell lung cancer (NSCLC) represents up to
85% of diagnoses.7 For some non-metastatic early-stage NSCLC
patients, surgery may be able to be used as a singular option for
treatment.8 However, 30% to 55% of patients can develop recurrence,
contributing to a need for treatment options administered before
surgery (neoadjuvant) and after surgery (adjuvant) to improve
long-term outcomes.2 Survival rates vary depending on the stage and
type of the cancer when diagnosed.7
INDICATIONS
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of
adult and pediatric patients 12 years and older with completely
resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO® (nivolumab), in combination with platinum-doublet
chemotherapy, is indicated as neoadjuvant treatment of adult
patients with resectable (tumors ≥4 cm or node positive) non-small
cell lung cancer (NSCLC).
OPDIVO® (nivolumab) in combination with platinum-doublet
chemotherapy, is indicated for neoadjuvant treatment of adult
patients with resectable (tumors ≥4 cm or node positive) non-small
cell lung cancer (NSCLC) and no known epidermal growth
factor receptor (EGFR) mutations or anaplastic lymphoma kinase
(ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant
treatment after surgery.
OPDIVO® (nivolumab), as a single agent, is indicated for the
adjuvant treatment of adult patients with urothelial carcinoma (UC)
who are at high risk of recurrence after undergoing radical
resection of UC.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of
completely resected esophageal or gastroesophageal junction cancer
with residual pathologic disease in adult patients who have
received neoadjuvant chemoradiotherapy (CRT).
IMPORTANT SAFETY
INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions listed herein may not include
all possible severe and fatal immune-mediated adverse
reactions.
Immune-mediated adverse reactions, which may be severe or fatal,
can occur in any organ system or tissue. While immune-mediated
adverse reactions usually manifest during treatment, they can also
occur after discontinuation of OPDIVO. Early identification and
management are essential to ensure safe use of OPDIVO. Monitor for
signs and symptoms that may be clinical manifestations of
underlying immune-mediated adverse reactions. Evaluate clinical
chemistries including liver enzymes, creatinine, and thyroid
function at baseline and periodically during treatment with OPDIVO.
In cases of suspected immune-mediated adverse reactions, initiate
appropriate workup to exclude alternative etiologies, including
infection. Institute medical management promptly, including
specialty consultation as appropriate.
Withhold or permanently discontinue OPDIVO depending on severity
(please see section 2 Dosage and Administration in the accompanying
Full Prescribing Information). In general, if OPDIVO interruption
or discontinuation is required, administer systemic corticosteroid
therapy (1 to 2 mg/kg/day prednisone or equivalent) until
improvement to Grade 1 or less. Upon improvement to Grade 1 or
less, initiate corticosteroid taper and continue to taper over at
least 1 month. Consider administration of other systemic
immunosuppressants in patients whose immune-mediated adverse
reactions are not controlled with corticosteroid therapy. Toxicity
management guidelines for adverse reactions that do not necessarily
require systemic steroids (e.g., endocrinopathies and dermatologic
reactions) are discussed below.
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. The incidence of
pneumonitis is higher in patients who have received prior thoracic
radiation. In patients receiving OPDIVO monotherapy,
immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients,
including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2
(2.1%).
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. A common symptom
included in the definition of colitis was diarrhea. Cytomegalovirus
(CMV) infection/reactivation has been reported in patients with
corticosteroid- refractory immune-mediated colitis. In cases of
corticosteroid-refractory colitis, consider repeating infectious
workup to exclude alternative etiologies. In patients receiving
OPDIVO monotherapy, immune-mediated colitis occurred in 2.9%
(58/1994) of patients, including Grade 3 (1.7%) and Grade 2
(1%).
Immune-Mediated Hepatitis and
Hepatotoxicity
OPDIVO can cause immune-mediated hepatitis. In patients
receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in
1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3
(1.3%), and Grade 2 (0.4%).
Immune-Mediated
Endocrinopathies
OPDIVO can cause primary or secondary adrenal insufficiency,
immune-mediated hypophysitis, immune-mediated thyroid disorders,
and Type 1 diabetes mellitus, which can present with diabetic
ketoacidosis. Withhold OPDIVO depending on severity (please see
section 2 Dosage and Administration in the accompanying Full
Prescribing Information). For Grade 2 or higher adrenal
insufficiency, initiate symptomatic treatment, including hormone
replacement as clinically indicated. Hypophysitis can present with
acute symptoms associated with mass effect such as headache,
photophobia, or visual field defects. Hypophysitis can cause
hypopituitarism; initiate hormone replacement as clinically
indicated. Thyroiditis can present with or without endocrinopathy.
Hypothyroidism can follow hyperthyroidism; initiate hormone
replacement or medical management as clinically indicated. Monitor
patients for hyperglycemia or other signs and symptoms of diabetes;
initiate treatment with insulin as clinically indicated.
In patients receiving OPDIVO monotherapy, adrenal insufficiency
occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2
(0.6%).
In patients receiving OPDIVO monotherapy, hypophysitis occurred
in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2
(0.3%).
In patients receiving OPDIVO monotherapy, thyroiditis occurred
in 0.6% (12/1994) of patients, including Grade 2 (0.2%).
In patients receiving OPDIVO monotherapy, hyperthyroidism
occurred in 2.7% (54/1994) of patients, including Grade 3
(<0.1%) and Grade 2 (1.2%).
In patients receiving OPDIVO monotherapy, hypothyroidism
occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and
Grade 2 (4.8%).
In patients receiving OPDIVO monotherapy, diabetes occurred in
0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2
(0.3%), and 2 cases of diabetic ketoacidosis.
Immune-Mediated Nephritis with Renal
Dysfunction
OPDIVO can cause immune-mediated nephritis. In patients
receiving OPDIVO monotherapy, immune-mediated nephritis and renal
dysfunction occurred in 1.2% (23/1994) of patients, including Grade
4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%).
Immune-Mediated Dermatologic Adverse
Reactions
OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative
dermatitis, including Stevens-Johnson syndrome (SJS), toxic
epidermal necrolysis (TEN), and drug rash with eosinophilia and
systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking
antibodies. Topical emollients and/or topical corticosteroids may
be adequate to treat mild to moderate nonexfoliative rashes.
Withhold or permanently discontinue OPDIVO depending on severity
(please see section 2 Dosage and Administration in the accompanying
Full Prescribing Information).
In patients receiving OPDIVO monotherapy, immune-mediated rash
occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and
Grade 2 (2.2%).
Other Immune-Mediated Adverse
Reactions
The following clinically significant immune-mediated adverse
reactions occurred at an incidence of <1% (unless otherwise
noted) in patients who received OPDIVO monotherapy or were reported
with the use of other PD-1/PD-L1 blocking antibodies. Severe or
fatal cases have been reported for some of these adverse reactions:
cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous
system: meningitis, encephalitis, myelitis and demyelination,
myasthenic syndrome/myasthenia gravis (including exacerbation),
Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy;
ocular: uveitis, iritis, and other ocular inflammatory toxicities
can occur; gastrointestinal: pancreatitis to include increases in
serum amylase and lipase levels, gastritis, duodenitis;
musculoskeletal and connective tissue: myositis/polymyositis,
rhabdomyolysis, and associated sequelae including renal failure,
arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism;
other (hematologic/immune): hemolytic anemia, aplastic anemia,
hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory
response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi
lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid
organ transplant rejection, other transplant (including corneal
graft) rejection.
Some ocular IMAR cases can be associated with retinal
detachment. Various grades of visual impairment, including
blindness, can occur. If uveitis occurs in combination with other
immune-mediated adverse reactions, consider a
Vogt-Koyanagi-Harada–like syndrome, which has been observed in
patients receiving OPDIVO, as this may require treatment with
systemic corticosteroids to reduce the risk of permanent vision
loss.
Infusion-Related Reactions
OPDIVO can cause severe infusion-related reactions. Discontinue
OPDIVO in patients with severe (Grade 3) or life-threatening (Grade
4) infusion-related reactions. Interrupt or slow the rate of
infusion in patients with mild (Grade 1) or moderate (Grade 2)
infusion-related reactions. In patients receiving OPDIVO
monotherapy as a 60-minute infusion, infusion-related reactions
occurred in 6.4% (127/1994) of patients. In a separate trial in
which patients received OPDIVO monotherapy as a 60-minute infusion
or a 30-minute infusion, infusion-related reactions occurred in
2.2% (8/368) and 2.7% (10/369) of patients, respectively.
Additionally, 0.5% (2/368) and 1.4% (5/369) of patients,
respectively, experienced adverse reactions within 48 hours of
infusion that led to dose delay, permanent discontinuation or
withholding of OPDIVO.
Complications of Allogeneic Hematopoietic Stem Cell
Transplantation
Fatal and other serious complications can occur in patients who
receive allogeneic hematopoietic stem cell transplantation (HSCT)
before or after being treated with OPDIVO. Transplant-related
complications include hyperacute graft-versus-host-disease (GVHD),
acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD)
after reduced intensity conditioning, and steroid-requiring febrile
syndrome (without an identified infectious cause). These
complications may occur despite intervening therapy between OPDIVO
and allogeneic HSCT.
Follow patients closely for evidence of transplant-related
complications and intervene promptly. Consider the benefit versus
risks of treatment with OPDIVO prior to or after an allogeneic
HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and findings from animal
studies, 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.
Increased Mortality in Patients with Multiple Myeloma when
OPDIVO is Added to a Thalidomide Analogue and Dexamethasone
In randomized clinical trials in patients with multiple myeloma,
the addition of OPDIVO to a thalidomide analogue plus dexamethasone
resulted in increased mortality. Treatment of patients with
multiple myeloma with a PD-1 or PD-L1 blocking antibody in
combination with a thalidomide analogue plus dexamethasone is not
recommended outside of controlled clinical trials.
Lactation
There are no data on the presence of OPDIVO in human milk, the
effects on the breastfed child, or the effects on milk production.
Because of the potential for serious adverse reactions in breastfed
children, advise women not to breastfeed during treatment and for 5
months after the last dose.
Serious Adverse Reactions
In Checkmate 238, serious adverse reactions occurred in 18% of
patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions
occurred in 25% of OPDIVO-treated patients (n=452). The most
frequent Grade 3 and 4 adverse reactions reported in ≥2% of
OPDIVO-treated patients were diarrhea and increased lipase and
amylase. In Checkmate 816, serious adverse reactions occurred in
30% of patients (n=176) who were treated with OPDIVO in combination
with platinum-doublet chemotherapy. Serious adverse reactions in
>2% included pneumonia and vomiting. No fatal adverse reactions
occurred in patients who received OPDIVO in combination with
platinum-doublet chemotherapy. In Checkmate 77T, serious adverse
reactions occurred in 21% of patients who received OPDIVO in
combination with platinum-doublet chemotherapy as neoadjuvant
treatment (n=228). The most frequent (≥2%) serious adverse
reactions was pneumonia. Fatal adverse reactions occurred in 2.2%
of patients, due to cerebrovascular accident, COVID-19 infection,
hemoptysis, pneumonia, and pneumonitis (0.4% each). In the adjuvant
phase of Checkmate 77T, 22% of patients experienced serious adverse
reactions (n=142). The most frequent serious adverse reaction was
pneumonitis/ILD (2.8%). One fatal adverse reaction due to COVID-19
occurred. In Checkmate 274, serious adverse reactions occurred in
30% of patients receiving OPDIVO (n=351). The most frequent serious
adverse reaction reported in ≥2% of patients receiving OPDIVO was
urinary tract infection. Fatal adverse reactions occurred in 1% of
patients; these included events of pneumonitis (0.6%). In Checkmate
577, serious adverse reactions occurred in 33% of patients
receiving OPDIVO (n=532). A serious adverse reaction reported in
≥2% of patients who received OPDIVO was pneumonitis. A fatal
reaction of myocardial infarction occurred in one patient who
received OPDIVO. In Checkmate 76K, serious adverse reactions
occurred in 18% of patients receiving OPDIVO (n=524). Adverse
reactions which resulted in permanent discontinuation of OPDIVO in
>1% of patients included arthralgia (1.7%), rash (1.7%), and
diarrhea (1.1%). A fatal adverse reaction occurred in 1 (0.2%)
patient (heart failure and acute kidney injury). The most frequent
Grade 3-4 lab abnormalities reported in ≥1% of OPDIVO-treated
patients were increased lipase (2.9%), increased AST (2.2%),
increased ALT (2.1%), lymphopenia (1.1%), and decreased potassium
(1.0%).
Common Adverse Reactions
In Checkmate 238, the most common adverse reactions (≥20%)
reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated
patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%),
rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28%
vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper
respiratory infection (22% vs 15%), and abdominal pain (21% vs
23%). The most common immune-mediated adverse reactions were rash
(16%), diarrhea/colitis (6%), and hepatitis (3%). In Checkmate 816,
the most common (>20%) adverse reactions in the OPDIVO plus
chemotherapy arm (n=176) were nausea (38%), constipation (34%),
fatigue (26%), decreased appetite (20%), and rash (20%). In
Checkmate 77T, the most common adverse reactions (reported in ≥20%)
in patients receiving OPDIVO in combination with chemotherapy
(n=228) were anemia (39.5%), constipation (32.0%), nausea (28.9%),
fatigue (28.1%), alopecia (25.9%), and cough (21.9%). In Checkmate
274, the most common adverse reactions (≥20%) reported in patients
receiving OPDIVO (n=351) were rash (36%), fatigue (36%), diarrhea
(30%), pruritus (30%), musculoskeletal pain (28%), and urinary
tract infection (22%). In Checkmate 577, the most common adverse
reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue
(34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal
pain (21%), and cough (20%). In Checkmate 76K, the most common
adverse reactions (≥20%) reported with OPDIVO (n=524) were fatigue
(36%), musculoskeletal pain (30%), rash (28%), diarrhea (23%) and
pruritis (20%).
Surgery Related Adverse Reactions
In Checkmate 77T, 5.3% (n=12) of the OPDIVO-treated patients who
received neoadjuvant treatment, did not receive surgery due to
adverse reactions. The adverse reactions that led to cancellation
of surgery in OPDIVO- treated patients were cerebrovascular
accident, pneumonia, and colitis/diarrhea (2 patients each) and
acute coronary syndrome, myocarditis, hemoptysis, pneumonitis,
COVID-19, and myositis (1 patient each).
Clinical Trials and Patient Populations
Checkmate 577–adjuvant treatment of esophageal or
gastroesophageal junction cancer; Checkmate 238–adjuvant treatment
of patients with completely resected Stage III or Stage IV
melanoma; Checkmate 76K–adjuvant treatment of patients 12 years of
age and older with completely resected Stage IIB or Stage IIC
melanoma; Checkmate 274–adjuvant treatment of urothelial carcinoma;
Checkmate 816–neoadjuvant non-small cell lung cancer, in
combination with platinum-doublet chemotherapy; Checkmate
77T–neoadjuvant treatment with platinum-doublet chemotherapy for
non-small cell lung cancer followed by single-agent OPDIVO as
adjuvant treatment after surgery.
Please see U.S. Full Prescribing Information for OPDIVO.
Bristol Myers Squibb: Creating a Better
Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision —
transforming patients’ lives through science. The goal of the
company’s cancer research is to deliver medicines that offer each
patient a better, healthier life and to make cure a possibility.
Building on a legacy across a broad range of cancers that have
changed survival expectations for many, Bristol Myers Squibb
researchers are exploring new frontiers in personalized medicine
and, through innovative digital platforms, are turning data into
insights that sharpen their focus. Deep understanding of causal
human biology, cutting-edge capabilities and differentiated
research platforms uniquely position the company to approach cancer
from every angle.
Cancer can have a relentless grasp on many parts of a patient’s
life, and Bristol Myers Squibb is committed to taking actions to
address all aspects of care, from diagnosis to survivorship. As a
leader in cancer care, Bristol Myers Squibb is working to empower
all people with cancer to have a better future.
About Bristol Myers Squibb’s Patient
Access Support
Bristol Myers Squibb remains committed to providing assistance
so that cancer patients who need our medicines can access them and
expedite time to therapy.
BMS Access Support®, the Bristol Myers Squibb patient access and
reimbursement program, is designed to help appropriate patients
initiate and maintain access to BMS medicines during their
treatment journey. BMS Access Support offers benefit investigation,
prior authorization assistance, as well as co-pay assistance for
eligible, commercially insured patients. More information about our
access and reimbursement support can be obtained by calling BMS
Access Support at 1-800-861-0048 or by visiting
www.bmsaccesssupport.com.
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, Ono and Bristol Myers
Squibb 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 us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook and
Instagram.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on current expectations and projections about our future
financial results, goals, plans and objectives and involve inherent
risks, assumptions and uncertainties, including internal or
external factors that could delay, divert or change any of them in
the next several years, that are difficult to predict, may be
beyond our control and could cause our future financial results,
goals, plans and objectives to differ materially from those
expressed in, or implied by, the statements. These risks,
assumptions, uncertainties and other factors include, among others,
whether Opdivo (nivolumab) in combination with chemotherapy for the
indication described in this release will be commercially
successful, any marketing approvals, if granted, may have
significant limitations on their use, and that continued approval
of such combination treatment for such indication described in this
release may be contingent upon verification and description of
clinical benefit in confirmatory trials. No forward-looking
statement can be guaranteed. Forward-looking statements in this
press release should be evaluated together with the many risks and
uncertainties that affect Bristol Myers Squibb’s business and
market, particularly those identified in the cautionary statement
and risk factors discussion in Bristol Myers Squibb’s Annual Report
on Form 10-K for the year ended December 31, 2023, as updated by
our subsequent Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and other filings with the Securities and Exchange
Commission. The forward-looking statements included in this
document are made only as of the date of this document and except
as otherwise required by applicable law, Bristol Myers Squibb
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
References
- Opdivo Prescribing Information. Opdivo U.S. Product
Information. Last updated: October 2024. Princeton, NJ:
Bristol-Myers Squibb Company.
- Cascone T, Awad M, Spicer J, et al. Perioperative Nivolumab in
Resectable Lung Cancer. N Engl J Med. 2024;390:1756-1769.
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non-small-cell lung cancer: Recent advances and future
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