Cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals) in combination with platinum-based chemotherapy was approved on Nov. 8, 2022, for first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. Cemiplimab-rwlc is a programmed cell death receptor-1 (PD-1) inhibitor antibody. The treatment is approved for either metastatic disease or locally advanced disease in patients who are not candidates for surgical resection or definitive chemoradiation. The recommended administration is intravenous (IV) infusion over 30 minutes every three weeks.

As with most monoclonal antibodies that bind to either the PD-1 or PD-ligand 1 (PD-L1), immune-related adverse reactions are possible and may be severe or fatal. The incidences were similar whether given as a single agent or combined with chemotherapy. Serious adverse reactions occurred in 25% of patients, with the most frequent (>2%) being pneumonia, anemia, and neutropenia. Fatal adverse reactions occurred in 6% of patients who received combined treatment. The most common adverse reactions, occurring in ≥15% in a clinical study, were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.

The approval was based on the results of a randomized, multicenter, double-blind, active-controlled clinical trial (Study 16113) of 466 patients who had not received prior systemic treatment. Patients treated with cemiplimab plus chemotherapy had a 29% relative reduction in the risk of death, as shown by the significantly improved median overall survival (OS) of nearly 22 months, compared with 13 months in the placebo plus chemotherapy arm (hazard ratio [HR], 0.71 [95% CI, 0.53-0.93]; P = .0140). Median progression-free survival (PFS), as evaluated by blinded independent central review, was 8.2 months in the treatment arm and 5 months in the placebo plus chemotherapy arm (P < .0001).

Cemiplimab was already approved for the treatment of cutaneous squamous cell carcinoma, basal cell carcinoma, and single-agent use in NSCLC with high PD-L1 expression.

References
FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer. 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-combination-platinum-based-chemotherapy-non-small-cell-lung-cancer

Libtayo (cemiplimab-rwlc) injection [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 11/2022.