Bristol-Myers Squibb Co. Announces Interim Results From Expanded Phase 1 Dose-Ranging Study 003 (n=296) Of Investigational Anti-PD-1 Immunotherapy (BMS-936558)

Bristol-Myers Squibb Co. announced interim results from the expanded Phase 1 dose-ranging study 003 (n=296) of its investigational anti-PD-1 immunotherapy (BMS-936558), which showed clinical activity in patients with previously-treated non small-cell lung cancer (NSCLC), metastatic melanoma and renal cell carcinoma (RCC). Anti-PD-1 is a fully-human antibody that targets the inhibitory receptor expressed on activated T-cells called PD-1 or programmed death-1. Objective response rates (ORs) across dose cohorts, as measured by standard RECIST criteria, ranged from 6% to 32% in NSCLC, 19% to 41% in metastatic melanoma and 24% to 31% in RCC. Most responses were durable. Drug-related serious adverse events occurred in 11% of patients who received BMS-936558. Drug-related adverse events of special interest, defined as those with potential immune-related etiology, were sometimes severe and life-threatening. Results from this Phase 1 study of anti-PD-1 showed clinical activity across NSCLC, metastatic melanoma and RCC, adding to our scientific understanding of the potential of immuno-oncology as a therapeutic approach in the treatment of cancer. Objective responses, as measured by standard RECIST criteria, were observed in patients treated with BMS-936558 across dose cohorts and across the NSCLC (6% to 32%), metastatic melanoma (19% to 41%) and RCC (6% to 32%) tumor types. Most responses were durable with response durations ≥1 year in 65% of responders with ≥1 year follow-up.