In the Phase 3 CheckMate -901 trial, Opdivo
with cisplatin and gemcitabine demonstrated a statistically
significant improvement in overall survival and progression-free
survival compared to cisplatin-gemcitabine alone1
This is the first concurrent
immunotherapy-chemotherapy combination approved for this patient
population in the U.S.
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S.
Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in
combination with cisplatin and gemcitabine, for the first-line
treatment of adult patients with unresectable or metastatic
urothelial carcinoma (UC), the most common type of bladder
cancer.1,2 This approval is based on results from the Phase 3
CheckMate –901 trial which evaluated Opdivo in combination with
cisplatin and gemcitabine followed by Opdivo monotherapy (n=304),
compared to cisplatin-gemcitabine alone (n=304), for patients with
previously untreated unresectable or metastatic UC.1,3 The primary
efficacy endpoints were overall survival (OS) and progression-free
survival (PFS) assessed by Blinded Independent Central Review
(BICR).1
In the trial, with a median follow-up of approximately 33
months, treatment with Opdivo in combination with cisplatin and
gemcitabine reduced the risk of death by 22%, demonstrating a
median OS of 21.7 months versus 18.9 months with
cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence
Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo
in combination with cisplatin and gemcitabine had their risk of
disease progression or death reduced by 28%, with a median PFS of
7.9 months compared to 7.6 months with cisplatin-gemcitabine alone
(HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
Additionally, in exploratory analyses, treatment with Opdivo in
combination with cisplatin and gemcitabine resulted in an objective
response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus
43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine
alone.1,4 The complete response (CR) rate and partial response (PR)
rate seen in patients treated with Opdivo in combination with
cisplatin and gemcitabine was 22% (n=66) and 36% (n=109),
respectively, versus 12% (n=36) and 31% (n=95) with
cisplatin-gemcitabine alone.1
“This approval marks an important advancement in a historically
difficult-to-treat setting, where there has been a need for new and
differentiated first-line approaches that may offer patients a
chance to live longer,”5 said Guru P. Sonpavde, MD, Medical
Director of Genitourinary Oncology and the Phase I Clinical
Research Unit and Christopher K. Glanz Chair for Bladder Cancer
Research at the AdventHealth Cancer Institute, Orlando, Florida.
“Based on outcomes and the safety profile seen in the CheckMate
-901 clinical trial, the approval of Opdivo in combination with
cisplatin and gemcitabine has the potential to change how
metastatic or unresectable UC is treated for certain patients and
offers them new hope.”1
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 with
renal dysfunction, other immune-mediated adverse reactions;
infusion-related reactions; complications of allogeneic
hematopoietic stem cell transplantation (HSCT); embryo-fetal
toxicity; and increased mortality in patients with multiple myeloma
when Opdivo is added to a thalidomide analogue and dexamethasone,
which is not recommended outside of controlled clinical trials.
Please see Important Safety Information below.1
“Bringing Opdivo to the first-line setting in UC with
chemotherapy is the latest realization of our history of research
and progress in immunotherapy, which has helped transform the
treatment landscape for many cancers, including bladder cancer,”1,6
said Wendy Short Bartie, senior vice president and general manager,
U.S. Hematology and Oncology at Bristol Myers Squibb. “This
milestone adds a meaningful expansion to our portfolio of
Opdivo-based treatments in genitourinary cancers, where we now have
offerings in UC spanning three indications across stages of disease
and treatment needs.”1
The FDA previously approved Opdivo for the adjuvant treatment of
adult patients with UC who are at high risk of recurrence after
undergoing radical resection of UC; it also previously approved
Opdivo for the treatment of adult patients with locally advanced or
metastatic UC who have had disease progression during or following
platinum-containing chemotherapy or have disease progression within
12 months of neoadjuvant or adjuvant treatment with
platinum-containing chemotherapy.1
Bristol Myers Squibb’s supplemental Biologics License
Application (sBLA) leading to today’s approval was granted Priority
Review status by the FDA, and was approved under the FDA’s
Real-Time Oncology Review (RTOR) pilot program, which aims to
ensure that safe and effective treatments are available to patients
as early as possible.7 The review was also conducted under the
FDA’s Project Orbis initiative, which enables concurrent review by
the health authorities in several other countries where the
application remains under review.
About CheckMate -901
CheckMate -901 is a Phase 3, randomized, open-label trial
evaluating Opdivo in combination with cisplatin and gemcitabine
followed by Opdivo monotherapy compared to cisplatin-gemcitabine
alone, in patients with previously untreated unresectable or
metastatic urothelial cancer.3
In the CheckMate -901 study, a total of 608 cisplatin-eligible
patients were randomized to receive either Opdivo 360 mg in
combination with cisplatin-gemcitabine every three weeks for up to
six cycles followed by Opdivo monotherapy 480 mg every 4 weeks
until disease progression or unacceptable toxicity up to a maximum
of two years, or cisplatin-gemcitabine alone every three weeks for
up to six cycles.1 The primary endpoints of this study were overall
survival (OS) and progression-free survival (PFS) assessed by
Blinded Independent Central Review (BICR).1,3 The OS and PFS
outcomes for cisplatin-eligible patients are based on the final
efficacy analyses of these endpoints.4
Select Safety Profile from CheckMate
-901
Serious adverse reactions occurred in 48% of patients receiving
Opdivo with chemotherapy.1 The most frequent serious adverse
reactions reported in ≥2% of patients who received Opdivo with
chemotherapy were urinary tract infection (4.9%), acute kidney
injury (4.3%), anemia (3%), pulmonary embolism (2.6%), sepsis
(2.3%), and platelet count decreased (2.3%).1 The most common
adverse reactions (reported in ≥20% of patients) were nausea,
fatigue, musculoskeletal pain, constipation, decreased appetite,
rash, vomiting, and peripheral neuropathy.1 Fatal adverse reactions
occurred in 3.6% patients who received Opdivo with chemotherapy;
these included sepsis (1%).1 Opdivo and/or chemotherapy were
discontinued in 30% of patients and were delayed in 67% of patients
for an adverse reaction.1
About Urothelial
Carcinoma
Bladder cancer is the sixth most common cancer in the U.S., with
an estimated 83,190 new cases expected to be diagnosed in 2024.2,8
Urothelial carcinoma, which most frequently begins in the cells
that line the inside of the bladder, accounts for approximately 90%
of bladder cancer cases.2,8 In addition to the bladder, urothelial
carcinoma can occur in other parts of the urinary tract, including
the ureters and renal pelvis.2 The majority of urothelial
carcinomas are diagnosed at an early stage, but approximately 50%
of patients who undergo radical surgery will experience disease
progression and recurrence, generally within two years
post-surgery.9,10,11,12,13 Approximately 20% to 25% of patients
with urothelial carcinoma present with metastatic disease, and
treatment challenges have historically persisted in the first- and
second-line settings, in part due to limited therapeutic
options.13,14,15
INDICATION
OPDIVO® (nivolumab), in combination with cisplatin and
gemcitabine, is indicated as first-line treatment for adult
patients with unresectable or metastatic urothelial carcinoma.
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 901, serious adverse reactions occurred in 48% of
patients receiving OPDIVO in combination with chemotherapy. The
most frequent serious adverse reactions reporting in ≥2% of
patients who received OPDIVO with chemotherapy were urinary tract
infection (4.9%), acute kidney injury (4.3%), anemia (3%),
pulmonary embolism (2.6%), sepsis (2.3%), and platelet count
decreased (2.3%). Fatal adverse reactions occurred in 3.6% of
patients who received OPDIVO in combination with chemotherapy;
these included sepsis (1%). OPDIVO and/or chemotherapy were
discontinued in 30% of patients and were delayed in 67% of patients
for an adverse reaction.
Common Adverse Reactions
In Checkmate 901, the most common adverse reactions (≥20%) were
nausea, fatigue, musculoskeletal pain, constipation, decreased
appetite, rash, vomiting, and peripheral neuropathy.
Please see US 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 in combination with cisplatin and gemcitabine for
the additional indication described in this release will be
commercially successful, that any marketing approvals, if granted,
may have significant limitations on their use, and, that continued
approval of such combination treatment for such additional
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.
corporatefinancial-news
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Myers Squibb Company.
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Participants With Untreated Inoperable or Metastatic Urothelial
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- Dason S, Cha EK, Falavolti C, et al. Late Recurrences Following
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comprehensive review of the literature. World J Urol.
2018;36(2):157-170. doi:10.1007/s00345-017-2115-4
- Svatek RS, Siefker-Radtke A, Dinney CP. Management of
metastatic urothelial cancer: the role of surgery as an adjunct to
chemotherapy. Can Urol Assoc J. 2009;3(6 Suppl 4):S228-S231.
doi:10.5489/cuaj.1203
- Vassiliou V, Katsila T, Sodergren SC, Kardamakis D.
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Clinical Applications. Anticancer Res. 2022;42(8):3767-3778.
doi:10.21873/anticanres.15867
- Apolo AB, Nadal R, Girardi DM, et al. Phase I Study of
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Bristol Myers Squibb (NYSE:BMY)
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