Eli Lilly and Bristol-Myers Squibb announced that they have stopped enrollment in one of their two global Phase 3 studies evaluating necitumumab as a first-line treatment for advanced non-small cell lung cancer (NSCLC). 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. The DMC raised 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.
The randomized, multi-center, open-label trial, named INSPIRE, is evaluating the addition of necitumumab, a fully-human IgG1 monoclonal antibody, to a combination of Alimta (pemetrexed for injection, from Eli Lilly) and cisplatin compared to a regimen of Alimta and cisplatin, as a first-line treatment for patients with advanced nonsquamous NSCLC.
Necitumumab is a fully-human IgG1 monoclonal antibody being developed in a partnership between Lilly and Bristol-Myers Squibb.