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FDA Approves Cemiplimab-rwlc and Expands Approval of Companion Diagnostic in NSCLC

By: Jocelyn Solis-Moreira, MS
Posted: Tuesday, February 23, 2021

On February 22, the U.S. Food and Drug Administration (FDA) approved the use of cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non—small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] ≥ 50%). These patients are not candidates for surgical resection or definitive chemoradiation therapy. This FDA approval comes in conjunction with an expanded approval of the companion diagnostic PD-L1 IHC 22C3 pharmDx assay to identify suitable candidates with tumor PD-L1 expression of TPS ≥ 50% for treatment with cemiplimab-rwlc.

The recommended cemiplimab-rwlc dose for treatment of NSCLC is 350 mg every 3 weeks, intravenously over 30 minutes. Cemiplimab-rwlc is a monoclonal antibody that targets and binds to PD-1 to suppress T-cell activation.

Cemiplimab-rwlc was evaluated based on the results of the multicenter, open-label Study 1624. The trial enrolled 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or who had metastatic NSCLC. Patients were randomly assigned to receive 350 mg intravenously every 3 weeks for up to 108 weeks or given platinum-based chemotherapy.

Trial results showed a median overall survival of 22.1 months with cemiplimab-rwlc compared with 14.3 months with chemotherapy. The median progression-free survival per blinded independent central review was 6.2 months in the cemiplimab-rwlc arm and 5.6 months in the chemotherapy arm. The overall response rate per blinded independent central review was 37% in the cemiplimab-rwlc arm and 21% in the chemotherapy arm.

The most common adverse reactions in more than 10% of patients given cemiplimab-rwlc included musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.



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