Dr. Brahmer on the PD-1 Immunotherapy BMS-936558

Julie R. Brahmer, MD, associate professor of oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, discusses a phase I clinical trial that investigated the experimental agent BMS-936558, a targeted immunotherapy agent that blocks the programmed death-1 (PD-1) receptor that is expressed by activated T cells, in multiple tumor types.

Brahmer explains this trial is the second to investigate this antibody in clinical trials for humans. On the trial, patients received BMS-936558 once every two weeks in an eight-week cycle for up to two years. The trial enrolled 296 patents with advanced melanoma, non-small cell lung cancer (NSCLC), colorectal cancer, renal cell carcinoma (RCC), and prostate cancer.

The dose escalation portion of the trial provided doses between 0.1 to 10.0 mg/kg but did not find a maximum tolerated dose because all dose sizes were well tolerated. BMS-936558 was generally well tolerated and all side effects of the agent were similar to other immunotherapies and included pneumonitis, hypophysitis, hepatitis, colitis, and thyroiditis.

Activity was noted prominently in patients with melanoma (28% of patients), RCC (27%), and NSCLC (18%). Brahmer notes that some patients demonstrated a prolonged response to the therapy that lasted not only for the two years they received the agent but also an additional year after the therapy was stopped.