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Bristol-Myers
Squibb Company
BMY today 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%
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