Safety Issues Prompt Lilly and BMS to Stop Enrollment into Phase III NSCLC Necitumumab Trial

Safety issues have led partners Eli Lilly and Bristol-Myers Squibb (BMS) to stop enrolling patients into one of two global Phase III studies evaluating the anticancer mAb candidate, necitumumab, as part of a combination therapy for the first-line treatment of lung cancer. An independent Data Monitoring Committee for the Inspire trial in patients with advanced non-small-cell lung cancer (NSCLC) flagged safety concerns related to the development of thromboembolism.

The risk of blood clots appears to be lower, however, once patients have received two rounds of therapy. As a result, study participants who have already received two cycles of treatment are being given the option to continue in the study.

The troubled Inspire study is evaluating the addition of the fully human IgG1 mab necitumumab to Lilly’s Alimta® and cisplatin. While no new patients will be enrolled, Lilly and BMS say the trial investigators will continue to assess patients after two treatment cycles to see whether necitumumab has any benefits.

The second ongoing Phase III necitumumab study, Squire, is evaluating the antibody in combination with Lilly’s Gemzar® and cisplatin in patients with squamous NSCLC. No safety concerns have been observed by the same DMC, and so this trial has been recommended for continuation, Lilly and BMS stress.

The two firms are sharing development costs of necitumumab and potential commercialization of the drug in the U.S., Canada, and Japan. Lilly has exclusive commercialization rights to the drug in all other countries.