Eli Lilly, Bristol-Myers Squibb stop enrollment in one Ph III lung cancer trials of necitumumab on blood clot concerns

US drug majors Eli Lilly (NYSE: LLY) and Bristol-Myers Squibb (NYSE: BMY) have stopped enrollment in one of their two global Phase III studies evaluating necitumumab, an investigational anti-cancer agent, as a first-line treatment for advanced non-small cell lung cancer (NSCLC).

The randomized, multicenter, open-label Phase III trial, named INSPIRE, is evaluating the addition of necitumumab, a fully-human IgG1 monoclonal antibody, to a combination Alimta (pemetrexed for injection) and cisplatin compared to a regimen of Alimta and cisplatin, as a first-line treatment for patients with advanced non-squamous NSCLC. No new safety issues were seen in the control arm with Alimta and cisplatin.

The companies said the decision to stop enrollment followed an independent Data Monitoring Committee (DMC) recommendation that no new or recently enrolled patients continue treatment in the trial because of safety concerns related to thromboembolism (blood clots) in the experimental arm of the study. The DMC also noted that patients who have already received two or more cycles of necitumumab appear to have a lower ongoing risk for these safety concerns. These patients may choose to remain on the trial, after being informed of the additional potential risks. Investigators will continue to assess patients after two cycles to determine if there is a potential benefit from treatment.