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Bristol-Myers Squibb Company (BMY) Release: Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Showed Antitumor Activity In Previously Treated And Chemotherapy-Naïve Patients In Phase 1b Non-Small Cell Lung Cancer Trials


5/15/2014 9:40:22 AM

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UXBRIDGE, England--(BUSINESS WIRE)--Bristol-Myers Squibb Company today announced results from a Phase1b study evaluating the safety and efficacy of its investigational PD-1 immune checkpoint inhibitor nivolumab as a single agent in patients with advanced non-small cell lung cancer (NSCLC) who were previously treated (Study -003) and a Phase 1b study evaluating nivolumab as a single agent in chemotherapy-naïve patients (CheckMate -012).1,2 In Study -003, the two-year survival rate was 24% across doses (n=129) for previously-treated patients who received nivolumab as a single agent and highest at 45% in patients who received the 3 mg/kg dose (n=37). In CheckMate -012, the overall response rate (ORR) was 50% (5/10) in PD-L1 positive tumours, 0% (0/7) in PD-L1 negative tumours, and 1/3 (33%) in patients with tumours unavailable for analysis for chemotherapy-naïve patients who received nivolumab as a single agent (n=20). The types of treatment-related serious adverse events (SAEs) in CheckMate -012 were consistent with those in other nivolumab trials with 15% of patients experiencing grade 3-4 treatment-related SAEs. These 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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