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Cemiplimab NSCLC Clinical Trial Halts Due to “Highly Significant” OS Improvement

A Phase 3 trial of cemiplimab as a first line monotherapy for patients with advanced NSCLC has halted early due to “highly significant improvement in overall survival,” according to the manufacturer.

Cemiplimab is an anti-PD-1 inhibitor immunotherapy currently approved for treatment of cutaneous squamous cell carcinoma.

The Phase 3 trial included 712 with locally advanced, PD-L1 positive, NSCLC.

Patients were randomized 1:1 to receive 350mg of cemiplimab every 3 weeks or standard chemotherapy care for four to six cycles.

Results showed that cemiplimab “decreased the risk of death by 32.4%.” The independent Data Monitoring Committee recommended that the clinical trial halt early due to these results.

According to the manufacturer, these data will be used to support a regulatory submission in 2020.

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