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BMS slides on nivolumab data

May 16, 2014 2:28 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) slid $3.19 to $48.93 on Thursday after reporting results for nivolumab ( BMS-936558), a human IgG4 mAb against PD-1 receptor ( PDCD1; PD-1; CD279), in abstracts for the American Society of Clinical Oncology meeting. Leerink's Seamus Fernandez attributed the sell-off in part to data from the Phase Ib CheckMate -012 trial of nivolumab alone and in combination with other agents in chemotherapy-naïve non-small cell lung cancer (NSCLC) patients, noting that the pharma is now trading "as if it is completely undifferentiated in lung cancer and perhaps immuno-oncology overall." ISI's Mark Schoenebaum said the CheckMate -012 data "weren't great" and noted that toxicity in the trial was "significant."

In 46 patients in CheckMate -012 who received nivolumab plus BMS's melanoma drug Yervoy ipilimumab followed by nivolumab alone, the overall response rate (ORR) was 13% compared to an ORR of 30% in 20 patients who received nivolumab alone. Patients with programmed cell death 1 ligand 1 ( PD-L1; B7-H1; CD274)-positive tumors (n=10) who received nivolumab alone had an ORR of 50% vs. 0% in patients with PD-L1-negative tumors (n=7). There were treatment-related adverse events in 85% of patients and grade 3/4 AEs in 15% of patients. In the trial, nivolumab in combination with chemotherapy regimens led to an ORR of 33-50%, with treatment-related AEs of 25-73%. ...