Opdivo is the first and only immuno-oncology
therapy proven to extend survival in patients treated with one
prior therapy
CheckMate -017 achieved the benchmark goal
of improving overall survival in previously treated squamous
non-small cell lung cancer (NSCLC)
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the
U.S. Food and Drug Administration (FDA) has approved Opdivo
(nivolumab) injection, for intravenous use, for the treatment of
patients with metastatic squamous non-small cell lung cancer
(NSCLC) with progression on or after platinum-based chemotherapy.
Opdivo is the first and only PD-1 (programmed death receptor-1)
therapy to demonstrate overall survival in previously treated
metastatic squamous NSCLC. Opdivo demonstrated significantly
superior overall survival (OS) vs. docetaxel, with a 41% reduction
in the risk of death (hazard ratio: 0.59 [95% CI: 0.44, 0.79;
p=0.00025]), in a prespecified interim analysis of a Phase III
clinical trial. The median OS was 9.2 months in the Opdivo arm (95%
CI: 7.3, 13.3) and 6 months in the docetaxel arm (95% CI: 5.1,
7.3).
“Bristol-Myers Squibb is committed to patients with lung cancer,
and we are pleased to offer Opdivo as the first immuno-oncology
therapy for patients who have previously treated metastatic
squamous NSCLC,” said Lamberto Andreotti, chief executive officer,
Bristol-Myers Squibb. “Because lung cancer is one of the most
commonly diagnosed cancers in the United States, with high
mortality, there is a significant need for treatments that extend
survival. We’re thankful to the many patients and healthcare
providers that partnered with us to develop a new treatment that
has the potential to address that unmet need.”
This approval is the second for Opdivo in the United States
within three months, and is based on the results of CheckMate -017
and CheckMate -063.
Opdivo is associated with immune-mediated: pneumonitis, colitis,
hepatitis, nephritis and renal dysfunction, hypothyroidism and
hyperthyroidism, other adverse reactions; and embryofetal toxicity.
Please see the Important Safety Information section below.
Proven Superior Survival vs. Standard of Care in a Phase III
Clinical Trial
CheckMate -017 was a landmark Phase III, open-label, randomized,
multinational, multicenter clinical trial that evaluated Opdivo (3
mg/kg intravenously over 60 minutes every two weeks) (n=135) vs.
standard of care, docetaxel (75 mg/m2 intravenously administered
every 3 weeks) (n=137), in patients with metastatic squamous NSCLC
who had progressed during or after prior platinum doublet-based
chemotherapy regimen. This trial included patients regardless of
their PD-L1 (programmed death ligand-1) status. The primary
endpoint of this trial was overall survival (OS).
In January, the trial was stopped based on an assessment
conducted by the independent Data Monitoring Committee (DMC), which
concluded that the study met its endpoint, demonstrating superior
OS in patients receiving Opdivo compared to docetaxel. The
prespecified interim analysis was conducted when 199 events (86% of
the planned number of events for final analysis) were observed (86
in the Opdivo arm and 113 in the docetaxel arm).
Opdivo is the only FDA-approved monotherapy to demonstrate
proven superior OS compared to standard of care in more than 15
years in previously treated metastatic squamous NSCLC. The median
OS was 9.2 months in the Opdivo arm (95% CI: 7.3, 13.3) and 6
months in the docetaxel arm (95% CI: 5.1, 7.3). The hazard ratio
was 0.59 (95% CI: 0.44, 0.79; p=0.00025). This hazard ratio
translates to a 41% reduction in the risk of death with Opdivo
compared to docetaxel.
“The FDA approval of Opdivo introduces an entirely new treatment
modality that has demonstrated unprecedented results for the
treatment of previously treated metastatic squamous NSCLC, with the
potential to replace chemotherapy for these patients,” said Dr.
Suresh Ramalingam, MD, Professor and Director of Medical Oncology,
Winship Cancer Institute of Emory University. “This milestone
brings to fruition the long-held hope that immuno-oncology
medicines can be significantly effective in this difficult-to-treat
population.”
About the CheckMate -063 Trial and the Safety Profile of
Opdivo
The safety profile of Opdivo in squamous NSCLC was established
in CheckMate -063, a Phase II single-arm, open-label,
multinational, multicenter trial of Opdivo, administered as a
single agent in patients with metastatic squamous NSCLC who have
progressed after receiving a platinum-based therapy and at least
one additional systemic treatment regimen (n=117). Patients
received 3 mg/kg of Opdivo administered intravenously over 60
minutes every 2 weeks. This trial included patients regardless of
their PD-L1 status. The most common adverse reactions (reported in
≥20% of patients) were fatigue (50%), dyspnea (38%),
musculoskeletal pain (36%), decreased appetite (35%), cough (32%),
nausea (29%), and constipation (24%). Serious adverse reactions
occurred in 59% of patients receiving Opdivo. The most frequent
serious adverse reactions reported in ≥2% of patients were dyspnea,
pneumonia, chronic obstructive pulmonary disease exacerbation,
pneumonitis, hypercalcemia, pleural effusion, hemoptysis, and pain.
Opdivo was discontinued due to adverse reactions in 27% of
patients. Twenty-nine percent of patients receiving Opdivo had a
drug delay for an adverse reaction.
With at least 10 months of minimum follow up for all patients,
the confirmed objective response rate (ORR), the study’s primary
endpoint, was 15% (17/117) (95% CI = 9, 22) of which all were
partial responses. The median time to onset of response was 3.3
months (range: 1.7 to 8.8 months) after the start of Opdivo
treatment. Seventy-six percent of Opdivo responders (13/17
patients) had ongoing responses with durability of response ranging
from 1.9+ to 11.5+ months; 10 of these 17 (59%) patients had
durable responses of 6 months or longer.
“The approval of Opdivo for the treatment of previously treated
metastatic squamous non-small cell lung cancer is a major
advancement in delivering extended survival for patients fighting
this deadly disease," said Andrea Ferris, President and Chairman,
Lungevity Foundation. “We are very excited for an immuno-oncology
therapy to enter the market and offer options and hope for many of
our patients. I applaud the FDA and Bristol-Myers Squibb for their
work in making this important and first of its kind treatment
available to patients so quickly.”
About Lung Cancer
Lung cancer is one of the leading causes of cancer deaths in the
United States. NSCLC is one of the most common types of the disease
and accounts for approximately 85 percent of cases. Squamous cell
NSCLC accounts for approximately 25 to 30 percent of all lung
cancers. Survival rates vary depending on the stage and type of the
cancer and when it is diagnosed. For Stage IV NSCLC, the five-year
survival rate is one percent.
About Bristol-Myers Squibb’s Patient Support Programs for
Opdivo
Bristol-Myers Squibb remains committed to helping patients
through treatment with Opdivo. 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 Support
Bristol-Myers Squibb is committed to helping patients access
Opdivo and offers numerous programs 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 Opdivo
specific reimbursement information, please visit the BMS Access
Support Product section by visiting
www.bmsaccesssupportopdivo.com.
About the Opdivo Clinical Development Program
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.
Indication and Important Safety Information for
OPDIVO® (nivolumab)
INDICATION
OPDIVO® (nivolumab) is indicated for the treatment of patients
with metastatic squamous non-small cell lung cancer (NSCLC) with
progression on or after platinum-based chemotherapy.
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.
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 www.bms.com or follow
us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb CompanyMedia:Carrie Fernandez,
609-419-5448cell: 215-859-2605carrie.fernandez@bms.comorChrissy
Trank, 609-419-5497cell:
732-551-5343christina.trank@bms.comorInvestors:John Elicker,
609-252-4611john.elicker@bms.comorRanya Dajani,
609-252-5330ranya.dajani@bms.com
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