Bristol-Myers Squibb Company BMY today announced updated survival data
from the advanced melanoma cohort (n=107) of the expanded Phase 1b
dose-ranging study of nivolumab, an investigational PD-1 immune checkpoint
inhibitor, administered as a single agent (Study -003). Results showed
sustained activity in this heavily pre-treated patient population as defined
by two- and three-year survival rates of 48% and 41%, respectively, across
dose cohorts. These data, which are based on Kaplan-Meier estimates, will be
featured in an oral presentation at the 50th Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago on June 2 at 3 p.m. CDT
(Abstract #9002).
“These Phase 1b results for nivolumab are encouraging in a group of patients
with one of the most aggressive forms of cancer,” said F. Stephen Hodi, M.D.,
director of the Melanoma Treatment Center and director of the Center for
Immuno-Oncology at Dana-Farber, and Associate Professor of Medicine at Harvard
Medical School. “They represent the longest follow up data for survival in
pre-treated advanced melanoma patients who have received an investigational
PD-1 immune checkpoint inhibitor as a single agent.”
“We are committed to improving survival expectations for patients with
advanced melanoma and to leading immuno-oncology research and development that
adds to the treatment options for patients across lines of therapy and stages
of disease,” said Michael Giordano, senior vice president, Head of
Development, Oncology & Immunology. “The updated results reported in this
Phase 1b study help to characterize the long-term survival of nivolumab in
this patient population. We look forward to presenting additional follow up
results at ASCO evaluating the combination regimen of nivolumab and Yervoy^®
(ipilimumab) in this tumor type along with the first reported results from a
Phase 3 trial of Yervoy as an investigational adjuvant therapy.”
Results from Advanced Melanoma Cohort of Phase 1b Single Agent Study (-003)
Study -003 is a Phase 1b dose escalation study (n=306) evaluating the safety,
antitumor activity and pharmacokinetics of nivolumab as a single agent in
previously-treated patients with advanced melanoma (n=107), non-small cell
lung cancer (NSCLC) (n=129), renal cell carcinoma (n=34), castration-resistant
prostate cancer (n=17) or colorectal cancer (n=19). Based on an amendment to
the protocol, patients were followed for survival. Eligible patients were
administered nivolumab as an intravenous infusion every two weeks of each
eight-week treatment cycle. Cohorts of three to six patients per dose level
(0.1, 0.3, 1.0, 3.0 or 10 mg/kg) were enrolled sequentially. Patients
continued treatment ≤2 years (12 cycles), unless they experienced complete
response, unacceptable toxicity, progressive disease or withdrew consent.
Results from this study were initially presented in 2012 at ASCO and published
in the New England Journal of Medicine. The initial and updated analysis is
reflective of 107 previously-treated advanced melanoma patients who had not
received prior treatment with Yervoy. Updated results reported here show
sustained activity in heavily pre-treated patients as defined by two- and
three-year survival rates of 48% and 41%, respectively, across dose cohorts.
Of the 32% of patients with objective responses (based on RECIST criteria),
the median duration of response was 22.9 months.
Safety data from this study published in the Journal of Clinical Oncology
earlier this year, with all patients having greater than or equal to one year
of follow up, demonstrated a spectrum, frequency and severity of
treatment-related adverse events (AEs) that were consistent with those
initially reported in the study in 2012. As reported, common drug-related AEs
included fatigue (32%), rash (23%), diarrhea (18%) and pruritus (13%).
Drug-related select AEs with potential immunologic etiologies, defined as
adverse events that may require more frequent monitoring and/or unique
intervention, included skin (36%), gastrointestinal (18%), endocrine (13%),
hepatic (6.5%), pulmonary (3.7%) and renal (1.9%).
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