Phase 2 study of ipilimumab for advanced non-small cell lung cancer (NSCLC)

Bristol-Myers Squibb announced positive results from its Phase 2 study evaluating ipilimumab in combination with standard chemotherapy in previously untreated patients with advanced non-small cell lung cancer (NSCLC). This study, known as Study 041, is a multi-center, randomized, double blind, three arm trial evaluating the efficacy and safety of ipilimumab in combination with paclitaxel/carboplatin compared to paclitaxel/carboplatin alone in previously-untreated patients with Stage IIIb or IV non-small cell lung cancer (n=203). The study 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 modified WHO criteria, also reached statistical significance in one of the two dosing schedules that combined ipilimumab with standard chemotherapy.

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.

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