Interim results from Bristol-Myers Squibb’s BMS-936558 Phase 1 study on NSCLC, MM and RCC

Bristol-Myers Squibb Company (NYSE: BMY) today 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.

The data on anti-PD-1 were published today in the New England Journal of Medicine¹ and featured in four oral presentations at the 48^th Annual Meeting of the American Society of Clinical Oncology (Abstract # 2509, 4505, 7509 and 8507). Additionally, abstracts from the NSCLC cohort (Abstract# 7509) and the melanoma cohort (Abstract #8507) of study 003 have been chosen for the Best of ASCO^® educational program.

"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," said Dr. Thomas J. Lynch, Jr., director of Yale Cancer Center and physician-in-chief of the Smilow Cancer Hospital at Yale-New Haven, which was involved in the clinical trials. "These data are encouraging and support further investigation of anti-PD-1 in large-scale, randomized Phase 3 trials."

"Immuno-oncology is a prioritized area of research and development at Bristol-Myers Squibb and we plan to initiate registrational studies for anti-PD-1 in NSCLC and RCC this year and late 2012, early 2013 for metastatic melanoma," said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. "Our commitment to advancing the science of immuno-oncology is underscored by the data presented at ASCO and published in the New England Journal of Medicine, our ongoing development programs for immuno-oncology assets including YERVOY^® (ipilimumab) and anti-PD-1, and the investment in the International Immuno-Oncology Network, a collaboration with leading cancer research centers."

Data on a second investigational immunotherapy from Bristol-Myers Squibb, anti-PD-L1 (BMS-936559), were also published today in the New England Journal of Medicine² and featured in an oral presentation at ASCO (Abstract # 2510). BMS-936559 is fully-human antibody that targets one of the immunosuppressive ligands for PD-1, PD-L1, which is often expressed on tumor, stromal and immune cells.