Five oral presentations to be featured from
Bristol-Myers Squibb’s broad lung cancer development
programs
Data from investigational
Opdivo+Yervoy regimen in previously untreated patients with
advanced non-small cell lung cancer, to be presented
Longer term overall survival data from two
pivotal Opdivo trials in patients with squamous non-small
cell lung cancer, to be presented
Bristol-Myers Squibb Company (NYSE:BMY) today announced data
from its Immuno-Oncology clinical development programs to be
presented at the 16th World Conference on Lung Cancer (WCLC) in
Denver, CO from September 6-9. The company is presenting Opdivo
(nivolumab) data in a broad set of patients with lung cancer,
across histologies and treatment settings. These data add to the
growing body of evidence that may help the scientific community
advance their understanding Opdivo’s role in the treatment of lung
cancer as a single agent and its potential in combination with
Yervoy (ipilimumab). Key oral presentations include:
- CheckMate -012, September 7 during
the 10:45am -12:15pm MDT Session: Safety and Efficacy of
First-Line Nivolumab and Ipilimumab in Non-Small Cell Lung
Cancer
- CheckMate -017, September 7 during
the 10:45am -12:15pm MDT Session: Phase 3, Randomized Trial of
Nivolumab vs Docetaxel in Advanced Squamous Cell Non-Small Cell
Lung Cancer
- CheckMate -063, September 7 during
the 10:45am -12:15pm MDT Session: Longer-Term Follow-Up of a
Phase 2 Study of Nivolumab in Patients with Advanced, Refractory
Squamous Non-Small Cell Lung Cancer
- CheckMate -153, September 7 during
the 10:45am -12:15pm MDT Session: Safety and Efficacy of
Nivolumab in an Ongoing Trial of a PD-L1+/- Patient Population with
Metastatic Non-Small Cell Lung Cancer
- CheckMate -017, September 9 during
the 9:00am - 4:45 p.m. MDT Session: Evaluation of
Disease-Related Symptoms in Patients with Advanced Squamous
Non-Small Cell Lung Cancer Treated with Nivolumab or Docetaxel
Michael Giordano, senior vice president, head of Development,
Oncology, Bristol-Myers Squibb commented, “Lung cancer has the
highest mortality rate of all cancers globally. This meeting is a
unique opportunity to focus on new, innovative science to help
address this devastating malignancy. We look forward to presenting
Opdivo data in advanced non-small cell lung cancer, showing
longer-term overall survival and important quality of life data, as
well as research into the Opdivo+Yervoy regimen in first line
treatment of lung cancer.”
The full set of data to be presented by Bristol-Myers Squibb
include the following:
Abstract #, Title, Author
Session Type, Date, Time, Location
Abstract #736: Phase 3, Randomized
Trial (CheckMate 017) ofNivolumab (NIVO) vs Docetaxel in Advanced
Squamous (SQ)Cell Non-Small Cell Lung Cancer (NSCLC)Author: K.
Reckamp
Oral
Monday, September 7th
10:45 – 12:15 PM MDT
Four Seasons Ballroom F1+F2
Abstract #828: Longer-Term
Follow-Up of a Phase 2 Study(CheckMate 063) of Nivolumab in
Patients with
Advanced, Refractory Squamous Non-Small
Cell Lung CancerAuthor: L. Horn
Oral
Monday, September 7th
10:45 – 12:15 PM MDT
Four Seasons Ballroom F1+F2
Abstract #786: Safety and Efficacy
of First-Line Nivolumab(NIVO; Anti-Programmed Death-1 [PD-1]) and
Ipilimumab inNon-Small Cell Lung Cancer (NSCLC)Author: N. Rizvi
Oral
Monday, September 7th
10:45 – 12:15 PM MDT
Four Seasons Ballroom F1+F2
Abstract #851: Safety and Efficacy
of Nivolumab in an OngoingTrial of a PD-L1+/- Patient Population
with Metastatic Non-Small Cell Lung CancerAuthor: M. Hussein
Oral
Monday, September 7th
10:45 – 12:15 PM MDT
Four Seasons Ballroom F1+F2
Abstract #733: Clinical Attributes
of Lung Cancer in USCommunity Oncology Practice: Implications for
ImmunotherapyAuthor: P. Reddy
Mini Oral
Monday, September 7th
4:45 – 6:15 PM MDT
Four Seasons Ballroom F1+F2
Abstract #774: Years of Life Lost
and Lifetime Earnings Lost inMetastatic Lung Cancer: Potential
Societal Benefits of ImprovedSurvival by Age and HistologyAuthor:
M. Danese
Mini Oral
Monday, September 7th
4:45 – 6:15 PM MDT
Mile High Ballroom 2c-3c
Abstract #783: Value of Innovation
in Systemic Therapy forUS Patients with Advanced/Metastatic
NSCLCAuthor: J. Nilsson
Mini Oral
Monday, September 7th
4:45 – 6:15 PM MDT
Mile High Ballroom 2c-3c
Abstract #1323: A Multicenter Phase
1B Study of Ceritinib plusNivolumab in Patients with ALK+
NSCLCAuthor: A. Shaw
Poster
Monday, September 7th
9:30 – 4:45 PM MDT
Exhibit Hall
Abstract #743: Evaluation of
Disease-Related Symptoms inPatients with Advanced Squamous
Non-Small Cell Lung CancerTreated with Nivolumab or
DocetaxelAuthor: R. J. Gralla
Oral
Wednesday, September 9th
4:45 – 6:15 PM MDT
Four Seasons Ballroom F1+F2
Abstract #781: Predictors of
Subsequent Lines of Therapy (LOTs)in Non-Small Cell Lung Cancer
(NSCLC)Author: E. Nadler
Poster
Wednesday, September 9th
9:30 – 4:45 PM MDT
Exhibit Hall
Abstracts for WCLC can be found online here:
http://wclc2015.iaslc.org/.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally,
resulting in more than 1.5 million deaths each year according to
the World Health Organization. NSCLC is one of the most common
types of the disease and accounts for approximately 85 percent of
cases. Survival rates vary depending on the stage and type of the
cancer when it is diagnosed. Globally, the five-year survival rate
for Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC,
the five-year survival rate drops to two percent.
About Opdivo
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 8,000 patients have been enrolled
worldwide.
Opdivo is a programmed death-1 (PD-1) immune checkpoint
inhibitor that has received approval from the U.S. Food and Drug
Administration (FDA) as a monotherapy in two cancer indications.
Opdivo became the first PD-1 immune checkpoint inhibitor to
receive regulatory approval anywhere in the world on July 4, 2014
when Ono Pharmaceutical Co. announced that it received
manufacturing and marketing approval in Japan for the treatment of
patients with unresectable melanoma. In the U.S., the FDA
granted its first approval for Opdivo for the treatment of
patients with unresectable or metastatic melanoma and disease
progression following Yervoy (ipilimumab) and, if BRAF
V600 mutation positive, a BRAF inhibitor. On March 4,
2015, Opdivo received FDA approval for the treatment of
patients with metastatic squamous non-small cell lung cancer
(NSCLC) with progression on or after platinum-based chemotherapy.
On July 20, the European Commission approved Nivolumab BMS for the
treatment of locally advanced or metastatic SQ NSCLC after prior
chemotherapy.
Immuno-Oncology at Bristol-Myers
Squibb
Surgery, radiation, cytotoxic or targeted therapies have
represented the mainstay of cancer treatment over the last several
decades, but long-term survival and a positive quality of life have
remained elusive for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is
leading research in an innovative field of cancer research and
treatment known as Immuno-Oncology, which involves agents whose
primary mechanism is to work directly with the body’s immune system
to fight cancer. The company is exploring a variety of compounds
and immunotherapeutic approaches for patients with different types
of cancer, including researching the potential of combining
Immuno-Oncology agents that target different pathways in the
treatment of cancer.
Bristol-Myers Squibb is committed to advancing the science of
Immuno-Oncology, with the goal of changing survival expectations
and the way patients live with cancer.
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 1 or Trial
3. In Trial 1, pneumonitis, including interstitial lung disease,
occurred in 3.4% (9/268) of patients receiving OPDIVO and none of
the 102 patients receiving chemotherapy. Immune-mediated
pneumonitis occurred in 2.2% (6/268) of patients receiving OPDIVO;
one with Grade 3 and five with Grade 2. 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 1, diarrhea or colitis
occurred in 21% (57/268) of patients receiving OPDIVO and 18%
(18/102) of patients receiving chemotherapy. Immune-mediated
colitis occurred in 2.2% (6/268) of patients receiving OPDIVO; five
with Grade 3 and one with Grade 2. 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 1, there was an increased
incidence of liver test abnormalities in the OPDIVO-treated group
as compared to the chemotherapy-treated group, with increases in
AST (28% vs 12%), alkaline phosphatase (22% vs 13%), ALT (16% vs
5%), and total bilirubin (9% vs 0). Immune-mediated hepatitis
occurred in 1.1% (3/268) of patients receiving OPDIVO; two with
Grade 3 and one with Grade 2. 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 1, there was an increased
incidence of elevated creatinine in the OPDIVO-treated group as
compared to the chemotherapy-treated group (13% vs 9%). Grade 2 or
3 immune-mediated nephritis or renal dysfunction occurred in 0.7%
(2/268) of patients. 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 1, Grade 1 or 2 hypothyroidism
occurred in 8% (21/268) of patients receiving OPDIVO and none of
the 102 patients receiving chemotherapy. Grade 1 or 2
hyperthyroidism occurred in 3% (8/268) of patients receiving OPDIVO
and 1% (1/102) of patients receiving chemotherapy. 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
- In Trial 1 and 3 (n=385), 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 1, serious adverse reactions
occurred in 41% of patients receiving OPDIVO. Grade 3 and 4 adverse
reactions occurred in 42% of patients receiving OPDIVO. The most
frequent Grade 3 and 4 adverse drug reactions reported in 2% to
<5% of patients receiving OPDIVO were abdominal pain,
hyponatremia, increased aspartate aminotransferase, and increased
lipase.
- 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 1 were rash (21%) and 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 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, 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
Squibb
Bristol-Myers Squibb is a global pharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit www.bms.com, or
follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that Opdivo will receive approval for these additional indications
in monotherapy or in combination with Yervoy. 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.
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Bristol-Myers SquibbMedia:Carrie Fernandez,
609-419-5448cell:
215-859-2605carrie.fernandez@bms.comorInvestors:Ranya
Dajani, 609-252-5330cell: 215-666-1515ranya.dajani@bms.comorBill
Szablewski, 609-252-5894cell:
215-801-0906william.szablewski@bms.com
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