Lilly Announces PRONOUNCE Trial Did Not Meet Primary Superiority Endpoint

Eli Lilly and Company LLY announced results from its PRONOUNCE trial of ALIMTA® (pemetrexed for injection) for treatment of nonsquamous non-small cell lung cancer (NSCLC) that was presented today at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Ill. The PRONOUNCE trial compared an ALIMTA (pemetrexed), carboplatin doublet regimen to a paclitaxel, carboplatin and bevacizumab triplet regimen. The study did not achieve its primary superiority endpoint of improved progression-free survival without grade four adverse events (G4PFS).  No significant difference was observed between the treatment arms for secondary endpoints of progression-free survival (PFS), overall survival, overall response rate and disease control rate.  Toxicity profiles observed in the trial were consistent with the known safety profiles of each therapy. "The history of ALIMTA clinical evaluation – from histology to its use in the maintenance therapy paradigm – encourages us to explore new avenues to determine if we can improve patient outcomes," said Richard Gaynor, M.D., vice president of product development and medical affairs for Lilly Oncology. "These data give us additional insights that further inform the vast body of ALIMTA clinical data." The safety and efficacy profile for ALIMTA has been the subject of Lilly-sponsored studies involving an estimated 32,500 patients over the span of almost 20 years.