Libtayo Cleared for Frontline Use in Advanced NSCLC With High PD-L1 Expression

The approval is based on data from the randomized, open-label phase 3 EMPOWER-Lung1 trial.

The Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc; Regeneron) for the first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (tumor proportion score [TPS] greater than or equal to 50%), as determined by an FDA-approved test. The indication applies to patients with EGFR-, ALK-, or ROS1-negative tumors that are not candidates for surgical resection or definitive chemoradiation.

The approval is based on data from the randomized, open-label phase 3 EMPOWER-Lung1 trial ( NCT03088540), which assessed Libtayo in 710 adults with advanced or metastatic NSCLC with high PD-L1 expression. Patients were randomly assigned 1:1 to receive either Libtayo monotherapy (n=356) or chemotherapy (n=354) for up to 32 months. The primary end point was overall survival (OS); key secondary end points included progression-free survival (PFS) and objective response rate (ORR), per BICR.

Results demonstrated that treatment with Libtayo reduced the risk of death by 32% compared with chemotherapy (hazard ratio [HR] 0.68; 95% CI, 0.53-0.87; P=.0022). The median overall survival was 22 months (95% CI, 17.7-not evaluable) in the Libtayo arm compared with 14 months (95% CI, 11.7-19.2) in the chemotherapy arm.Moreover, treatment with Libtayo was associated with a median PFS of 6.2 months (95% CI, 4.5-8.3) compared with 5.6 months (95% CI, 4.5-6.1) in the chemotherapy arm (HR 0.59; 95% CI, 0.49-0.72; P<.0001). The ORR was 37% (95% CI, 32-42) and 21% (95% CI, 17-25) in the Libtayo and chemotherapy arms, respectively.

“As published in The Lancet, in a prespecified analysis in the subset of patients proven to have PD-L1 expression of at least 50%, Libtayo reduced the risk of death by 43% compared to chemotherapy,” said Ahmet Sezer, MD, Professor in the Department of Medical Oncology at Başkent University in Adana, Turkey and a trial investigator. “This was achieved with a greater than 70% crossover rate to Libtayo following disease progression on chemotherapy, as well as the largest population of patients with pretreated and clinically stable brain metastases among advanced NSCLC pivotal trials to date.”

As for safety, the most common adverse reactions (incidence of greater than or equal to 40%) reported with Libtayo were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia and cough.

Libtayo, a programmed death receptor-1 (PD-1) blocking antibody, is also indicated for the treatment of cutaneous squamous cell carcinoma and basal cell carcinoma.


1. FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%. [press release]. Paris, FR and Tarrytown, NY: Sanofi; February 22, 2021.

2. FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression. [press release]. Silver Springs, MD: US Food and Drug Administration; February 22, 2021.

3. Libtayo [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; 2021.