Eli Lilly announced Tuesday that a Phase III study of necitumumab met its main goal, demonstrating that the experimental drug increased overall survival in patients with stage IV metastatic squamous non-small-cell lung cancer (NSCLC). The company, whose shares gained as much as 6 percent on the news, indicated that it plans to submit regulatory filings for necitumumab before the end of 2014.
"If approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer," remarked Richard Gaynor, vice president of Eli Lilly's Oncology division. The SQUIRE trial enrolled 1093 patients at least 18 years of age with stage IV squamous NSCLC, who had received no prior therapy for metastatic disease. Patients were randomised to receive first-line necitumumab plus chemotherapy consisting of Eli Lilly's Gemzar (gemcitabine) and cisplatin, or Gemzar and cisplatin alone.
ISI Group analyst Mark Schoenebaum described the study results as a "clear upside surprise," noting that analysts had "basically zero" expectations for the drug. However, Schoenebaum suggested "we really need to see the full data to understand risk/benefit." JP Morgan analyst Chris Schott, who agreed that the expectations for the drug were "close to zero," estimated that the therapy could have annual sales in excess of $1 billion, if approved. The company said it plans to present results from the SQUIRE study at a scientific meeting in 2014.
A prior late-stage study of necitumumab plus Eli Lilly's Alimta (pemetrexed) and chemotherapy in nonsquamous NSCLC was halted  in 2011 due to safety concerns related to thromboembolism in the experimental arm of the study. Earlier this year, the company stated  that its partner Bristol-Myers Squibb terminated an agreement to co-develop the therapy and returned the full rights to Eli Lilly.