LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated:...in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is:...locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic.

The following regimens recommended added as Other Recommended for adenocarcinoma, large cell, NSCLC NOS….Cemiplimab-rwlc + paclitaxel + (carboplatin or cisplatin) (category 1)…Cemiplimab-rwlc + pemetrexed + (carboplatin or cisplatin) (category 1)

At 3 year follow-up, HRs of CEMI vs. chemo improved (vs at 13 m follow-up) for both PFS and OS despite 76% crossover rate, an exceptional finding in the NSCLC field. Continued CEMI + chemo as 2L therapy provided meaningful and durable ORR and OS benefits and these results compare favorably to historical data of pts receiving chemo alone as 2L therapy (after immune-checkpoint inhibitor monotherapy). This data is the first report from a Phase 3 study providing therapeutic advantage to pts who progress after 1L PD1 monotherapy.

Regeneron Pharmaceuticals, Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC)....The sBLA is supported by results from a randomized, multicenter Phase 3 trial that investigated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone.