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Bristol-Myers Squibb Co Announces Phase 1 Results from First Trial Combining Immune Checkpoint Inhibitors, Investigational Agent Nivolumab and Yervoy (ipilimumab), in Patients with Advanced Melanoma


Sunday, 2 Jun 2013 12:06pm EDT 

Bristol-Myers Squibb Co announced results from Study 004, a dose-ranging Phase 1 trial (n=86) evaluating the safety and anti-tumor activity of its investigational PD-1 receptor blocker, nivolumab, combined either concurrently (n=53) or sequentially (n=33) with Yervoy (ipilimumab) in patients with advanced melanoma. In patients who received the dose used in the Phase 3 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%). 

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