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Bristol-Myers Squibb Company (BMY) Release: In Phase 2 And 1b Renal Cell Carcinoma Trials, Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Showed Antitumor Activity As A Single Agent And In Combination Regimen With Yervoy® (Ipilimumab)



5/15/2014 9:27:20 AM

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PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase 2 and a Phase 1b study of its investigational PD-1 immune checkpoint inhibitor nivolumab in patients with advanced or metastatic renal cell carcinoma (RCC), commonly known as kidney cancer. In the Phase 2 CheckMate -010 trial (n=168), which evaluated three doses of nivolumab as a single agent in patients with previously treated RCC, the overall response rate (ORR) for nivolumab as a single agent ranged from 20-22% with a one-year survival rate that ranged from 63-72% in patients who received prior anti-angiogenic treatment. In the Phase 1b CheckMate -016 trial, which evaluated the safety and tolerability of nivolumab at different doses and schedules as part of a regimen with other agents, ORR for the investigational combination regimen of nivolumab and Yervoy (ipilimumab) (n=44) ranged from 43-48% with a 24-week progression free survival (PFS) rate that ranged from 64-65% in previously treated and treatment-naïve patients. The data will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place in Chicago May 30-June 3.

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