Bristol-Myers Squibb announces positive results from Phase 2 study of ipilimumab in patients with NSCLC

May 21 2010

Bristol-Myers Squibb Company (NYSE: BMY) today announced positive results from a randomized Phase 2 study evaluating ipilimumab in combination with standard chemotherapy in previously untreated patients with advanced non-small cell lung cancer (NSCLC). The study, known as 041, met the predefined criteria for significant improvement (p-value of <0.1) in immune-related progression -free survival (irPFS), the primary endpoint, over chemotherapy alone. An additional analysis of progression-free survival (PFS), assessed using traditional mWHO criteria, also reached statistical significance in one of the two dosing schedules that combined ipilimumab with standard chemotherapy. (Abstract #7531)

“Results from this Phase 2 study are very encouraging and support further investigation of ipilimumab in NSCLC in large scale Phase 3 trials”

"Results from this Phase 2 study are very encouraging and support further investigation of ipilimumab in NSCLC in large scale Phase 3 trials," said Dr. Thomas J. Lynch, Jr., director of Yale Cancer Center and physician-in-chief of the Smilow Cancer Hospital at Yale-New Haven. "As with melanoma, ipilimumab brings an innovative approach to lung cancer, which is very difficult to treat. These results add to our understanding of the potential of immuno-oncology in the treatment of cancer."

Ipilimumab is a T-cell potentiator that specifically blocks the inhibitory signal of CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. Suppression of CTLA-4 can augment the immune system's T-cell response in fighting disease.

The 041 study evaluated two distinct regimens of ipilimumab in combination with a chemotherapy regimen that is commonly used to treat advanced NSCLC in the first-line setting compared to the same chemotherapy regimen given alone. The ipilimumab arms improved irPFS by approximately one month compared to the chemotherapy-only arm. Immune-related adverse events reported in the study included gastrointestinal, skin, liver, or endocrine systems.

Planning for a Phase 3 study of ipilimumab in the treatment of NSCLC is under way. Ipilimumab is an investigational compound and not currently approved for use by health authorities.

Study Results

Immune-related PFS was 5.52 months (hazard ratio, 0.775;>

Grade 3/4 adverse events (AEs) were 58%, 52% and 42% for the concurrent, phased and chemotherapy alone groups, respectively, and were reflective of previously reported events for these individual agents. The incidences of Grade 3/4 immune-related AEs were 20% and 15% for the concurrent and phased groups, respectively. Immune-related adverse events were treated with the use of supportive care and systemic steroids using established protocol-specific treatment guidelines.

SOURCE Bristol-Myers Squibb Company