LLY's necitumumab meets in Phase III NSCLC trial

Eli Lilly and Co. (NYSE:LLY) said first-line treatment with IV nectiumumab plus gemcitabine and cisplatin met the primary endpoint of improving overall survival (OS) vs. gemcitabine and cisplatin alone in the Phase III SQUIRE trial to treat non-small cell lung cancer (NSCLC). Eli Lilly did not disclose detailed data from the open-label, international trial, which enrolled 1,093 stage IV squamous NSCLC patients. The pharma said it plans to present additional data at a scientific meeting next year and to submit regulatory applications for nectiumumab by year end 2014.

In its 1Q13 earnings in January, Lilly disclosed that former partner Bristol-Myers Squibb Co. (NYSE:BMY) had returned rights to necitumumab following a portfolio review. Lilly, which gained necitumumab through its 2008 acquisition of ImClone Systems Inc., and Bristol-Myers had originally partnered in 2010 to co-develop and co-commercialize the human IgG1 mAb against EGFR in the U.S., Canada and Japan. ...