Eli Lilly and Bristol-Myers Squibb on Wednesday announced that the companies stopped enrolment in one of two late-stage trials of necitumumab as a first-line treatment for patients with advanced nonsquamous non-small-cell lung cancer amid safety concerns related to thromboembolism in the experimental arm of the study.
The INSPIRE study is evaluating the drug in combination with Eli Lilly's Alimta (pemetrexed) and chemotherapy. An independent data monitoring committee noted that patients in the INSPIRE study who had received two or more cycles of necitumumab appear to have a lower risk of thromboembolism and thus may choose to continue with the trial. The panel also recommended that enrolment continue in the Phase III SQUIRE trial, which is evaluating necitumumab in combination with Eli Lilly's Gemzar (gemcitabine) and chemotherapy for the treatment of squamous NSCLC.
Eli Lilly and Bristol-Myers Squibb are sharing the costs of developing necitumumab and any potential commercialisation costs within North America and Japan. Eli Lilly retains exclusive rights in all other countries.
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