BMS success with nivolumab + ipilimumab in Melanoma

Study 004, a dose-ranging Phase 1 trial (n=86) evaluating the safety and anti-tumor activity of investigational PD-1 receptor blocker, nivolumab, combined either concurrently (n=53) or sequentially (n=33) with Yervoy (ipilimumab) rom BMS in patients with advanced Melanoma. In patients who received the dose used in the Phase III trial (1 mg/kg nivolumab + 3 mg/kg Yervoy) in the concurrent regimen, 53% (n= 9 of 17) had confirmed objective responses (OR) by mWHO criteria. In all nine of these responders, tumors shrank by at least 80% by the time of the first scheduled clinical treatment assessment (12 weeks), including three complete responses (CRs). In response-evaluable patients across all concurrent cohorts, 40% (n= 21 of 52) had an OR. Sixteen patients (31%) had tumor shrinkage of at least 80% by the time of the first clinical trial assessment, including five CRs. Responses were ongoing among 19 of 21 responders, with responses lasting from between 6.1+ to 72.1+ weeks at the time of data analysis. Clinical activity was observed in both the concurrent and sequenced regimens. Median overall survival has not been reached after approximately 13 months of median follow up in the concurrent cohorts.

The estimated one-year survival rate across all concurrent cohorts was 82% (95% CI 69.0 � 94.4%).Grade 3-4 treatment-related adverse events occurred in 53% of patients on the concurrent-regimen and 18% of patients on the sequenced-regimen. No treatment-related deaths were reported.

The data on nivolumab in combination with Yervoy were published in the New England Journal of Medicine (NEJM). The estimated survival data were presented at the 49th Annual Meeting of the American Society of Clinical Oncology.(Abstract # 9012).

see "Nivolumab plus Ipilimumab in Advanced Melanoma�monoclonal antibody blocking cytotoxic T-lymphocyte�associated antigen 4 (CTLA-4), improved overall survival in patients with advanced melanoma" -June 2, 2013 Wolchok J.D., Kluger H., Callahan M.K., et al.10.1056/NEJMoa1302369.