Lilly and BMS halt cancer study enrolment

Lilly and Bristol-Myers Squibb (BMS) have halted enrolment in a late-stage clinical study of an investigational treatment for advanced non-small cell lung cancer (NSCLC) due to safety concerns. 

The study, called INSPIRE, is one of two global phase III trails of necitumumab, a fully-human IgG1 monoclonal antibody. The second trial, known as SQUIRE, is testing the treatment in squamous non-small cell lung cancer, and will continue to enroll patients.

Enrolment in the INSPIRE trial was stopped after an independent Data Monitoring Committee (DMC) raised concerns about blood clots in the experimental arm of the study. The DMC advised that, due to the risk, no new or recently enrolled patients should be given the drug.

However, the DMC acknowledged that patients who have already received two or more cycles of necitumumab seem to have a lower ongoing risk, and so recommended that those patients be permitted to remain on the study drug if they choose to do so after being informed of the safety concerns.  

The open-label INSPIRE trial is testing the effectiveness of adding necitumumab to a combination of  Lilly's Alimta (pemetrexed for injection) and the chemotherapy drug cisplatin as a first-line treatment for patients with advanced nonsquamous NSCLC. No new safety issues were seen in a control arm in which patients received only Alimta and cisplatin.

The ongoing SQUIRE trial, which is testing necitumumab in combination with Lilly's Gemzar (gemcitabine for injection) and cisplatin for squamous non-small cell lung cancer, can continue without changes, as no new safety concerns have been observed, the DMC determined. 

Necitumumab has been viewed as a potential follow-up drug to Erbitux (cetuximab), the cancer drug that Lilly and BMS already co-market. Because necitumumab is a fully human antibody, rather than part mouse like Erbitux, the companies had hoped it would have fewer safety issues.

Under the companies' partnership deal, Lilly and BMS share development costs and commercialisation rights for necitumumab in the US, Canada and Japan, while Lilly has exclusive rights in all other markets.