Eli Lilly and Bristol-Myers Squibb have suffered something of a setback with the news that enrollment one of two late-stage trials of their lung cancer drug necitumumab has been halted due to concerns over blood clots.
The companies say that the Phase III trial, INSPIRE, is evaluating the addition of necitumumab, a fully-human IgG1 monoclonal antibody, to a combination of Lilly’s injectable Alimta (pemetrexed) and cisplatin compared to a regimen of the latter two, as a first-line treatment for patients with advanced non-squamous, non-small cell lung cancer. However, an independent data monitoring committee has recommended that no new or recently enrolled patients continue treatment because of concerns related to thromboembolism.
The DMC also noted that patients who have already received two or more cycles of necitumumab appear to have a lower ongoing risk of blood clots and they may choose to remain on the trial, after being informed of the additional potential risks.
Necitumumab will continue to be studied in another Phase III trial, SQUIRE. which is evaluating the drug for squamous NSCLC in combination with Lilly’s Gemzar (gemcitabine) and cisplatin. The DMC noted that no safety concerns have been observed in that study.
The firms are sharing the costs of developing necitumumab and any potential commercialisation within North America and Japan. Lilly retains exclusive rights everywhere else to the drug which it inherited following its $6.5 billion acquisition of ImClone Systems in 2008.
