BMY reports interim results from Phase 1 trial of anti-PD-1 immunotherapy

The fully-human antibody targets the inhibitory receptor expressed on activated T-cells called PD-1 or programmed death-1.

In the dose-ranging study 003, the anti-PD-1 immunotherapy (BMS-936558), showed clinical activity in NSCLC metastatic melanoma and RCC patients.

BMY global development and medical affairs senior vice president Brian Daniels said immuno-oncology is a prioritized area of research and development and the company plans to initiate registrational studies for anti-PD-1 in NSCLC and RCC this year and late 2012, early 2013 for metastatic melanoma.

Objective response rates 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. The study reported that most responses were durable.

Drug-related serious adverse events were observed in 11% patients. Drug-related adverse events of special interest, defined as those with potential immune-related etiology, were found to be life-threatening at times.