Phase III trial of Alimta (Eli Lilly) fails to meet primary endpoint in NSCLC

Results from the PRONOUNCE trial of Alimta (pemetrexed for injection), from Eli Lilly, for treatment of nonsquamous Non-Small Cell Lung Cancer (NSCLC) did not achieve its primary superiority endpoint of improved progression-free survival without grade four adverse events (G4PFS). PRONOUNCE is a randomized, open-label Phase III superiority study of first-line chemotherapy pemetrexed plus carboplatin (PemC regimen) followed by maintenance pemetrexed, compared to paclitaxel plus carboplatin plus bevacizumab (PacCBev regimen) followed by maintenance bevacizumab.

The primary endpoint, G4PFS was measured by the Common Terminology Criteria for Adverse Events (CTCAE). Secondary endpoints were progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and disease control rate (DCR). The median G4PFS was 3.91 months on the PemC regimen vs. 2.86 months on the PacCBev regimen. No significant difference was observed between the treatment arms for secondary endpoints of PFS, OS, ORR and DCR. There were no unexpected toxicities in either regimen. Data was presented at ASCO.