Bristol-Myers Offers Two-, Three-Year Survival Data for Nivolumab

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%).