- Interim results show favorable safety profile of Opdivo, and durable responses in previously-treated patients
- Overall survival rate of 62% at 12 months observed at this interim analysis
- Hepatocellular
carcinoma is the second most frequent cause of cancer-related
death worldwide and remains an area of significant unmet medical
need
- Patients with
hepatocellular carcinoma who have relapsed or have disease
progression, following standard of care, have a median survival
with best supportive care of ~7 to 8 months
PRINCETON, N.J.--(
BUSINESS WIRE)--
Bristol-Myers
Squibb Company (NYSE:BMY)
today
announced results from
an interim analysis of CA209-040, a Phase I/II dose-ranging trial
evaluating the safety and anti-tumor activity of
Opdivo (nivolumab)
in previously-treated patients with hepatocellular carcinoma (HCC) or
advanced liver cancer. Initial findings demonstrated that the estimated
survival rate in evaluable patients (n=47) was 62% at 12 months. Results
also show the safety profile of
Opdivo is generally consistent
with that previously-reported for
Opdivo in other tumor types.
These data will be featured today, May 29, during the 51st Annual
Meeting of the American Society of Clinical Oncology (ASCO) press
briefing at 1:00 – 2:00 p.m. CDT and presented on Saturday, May 30 from
8:27 a.m. – 8:39 a.m. CDT (Late Breaking Abstract #101).
“Hepatocellular carcinoma is an aggressive and fatal cancer, comprising
90 percent of all liver cancer in adults worldwide with limited
therapeutic options for patients with advanced stage disease; no
treatment advances have been made for patients who fail to respond or
progress on the current standard of care,” said Anthony B. El-Khoueiry,
MD, lead study author and associate professor of clinical medicine and
phase I program director at the University of Southern California Norris
Comprehensive Cancer Center. “These preliminary data are encouraging and
support the ongoing evaluation of nivolumab in this patient population,
as they show promising preliminary survival data, and durable partial or
complete response in one out of five nivolumab-treated patients, with
many others experiencing stable disease.”
More than 700,000 people around the world are diagnosed with HCC each
year with a majority of all HCC cases caused by infection with the
hepatitis B virus (HBV) or hepatitis C virus (HCV), making HBV/HCV the
most common risk factor for liver cancer worldwide. Patients with
advanced HCC receiving the current standard of care have a median
overall survival of less than 1 year. For patients who have relapsed or
have disease progression, median survival with best supportive care is
approximately 7 to 8 months.
“Bristol-Myers Squibb’s experience in hepatitis and Immuno-Oncology make
us poised as leaders to advance
Opdivo into additional studies of
hepatocellular carcinoma,” said Michael Giordano, senior vice president,
Head of Development, Oncology, Bristol-Myers Squibb. “
Opdivo has
demonstrated improvements in survival in a number of different tumor
types. We are excited that this trial has shown the potential that this
may extend to advanced liver cancer and hope to confirm these findings
in future trials.”
About the CA209-040
CA209-040 is a Phase I/II dose-ranging trial that evaluated the safety
and anti-tumor activity of
Opdivo in patients with HCC, the
majority of whom had received prior treatment. The trial included 47 HCC
patients who were enrolled into one of three treatment arms depending on
whether or not they were infected with HCV or HBV. Patients enrolled in
the trial received
Opdivo doses ranging from 0.1 – 10 mg/kg
intravenously every 2 weeks for up to 2 years. The primary objective was
safety, tolerability, dose limiting toxicities, and maximum tolerated
dose. Anti-tumor activity was a secondary objective (using RECIST 1.1
criteria), and overall survival was an exploratory objective.
As of this interim analysis, 62% of patients in the study were still
alive after 12 months. Eight (19%) patients (of 42 evaluable patients)
achieved a complete or partial response, meaning that the size of their
tumors measured at baseline decreased by 30–100% with
Opdivo
treatment. In patients with response, duration of response ranged from
more than 1.4 – 12.5 months. Seventeen patients remained on study
treatment and 30 discontinued treatment due to progressive disease
(n=26), complete response (n=2), or adverse events (n=2).
CA209-040 is the first trial to characterize the safety profile of
Opdivo
monotherapy in patients with HCC, including those with HCV and HBV
infections. In the trial, safety and tolerability were
well-characterized, with the frequency and intensity of
treatment-related adverse events (AEs) being consistent across
Opdivo
dose levels. The majority of side effects were mild to moderate in
nature with abnormal liver enzymes (19% AST and 15% ALT), rash (17%) and
elevation of amylase (15%) and lipase (17%) being the most common; the
abnormal liver enzymes and elevated amylase and lipase were not
accompanied by any significant clinical symptoms. Grade 3–4
treatment-related AEs were infrequent (19%). There were no
treatment-related deaths reported.
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 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 U.S. Food and Drug
Administration (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 its second FDA approval for the treatment of patients with
metastatic squamous non-small cell lung cancer (NSCLC) with progression
on or after platinum-based chemotherapy.
Read complete press release here