FDA Approval Insights: Cemiplimab in Advanced PD-L1–High NSCLC and Advanced Basal Cell Carcinoma

Welcome to OncLive On Air^TM! I’m your host today, Caroline Seymour.

OncLive On Air^TM is a podcast from OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions. 

In today’s episode, we had the pleasure of speaking with Ahmet Sezer, MD, a professor in the Department of Medical Oncology at Başkent University in Adana, Turkey, and Alexander J. Stratigos, MD, an associate professor of Dermatology and Venereology in the Department of Dermatology at the University of Athens Medical School, to discuss the FDA approvals of cemiplimab-rwlc (Libtayo) in advanced non–small cell lung cancer (NSCLC) and advanced basal cell carcinoma (BCC).

First, we spoke with Dr. Sezer. On February 22, 2021, the FDA approved cemiplimab monotherapy for use as frontline treatment for patients with advanced NSCLC with a PD-L1 expression level of 50% or higher. The regulatory decision was based on findings from the phase 3 EMPOWER-Lung1 trial, in which cemiplimab reduced the risk of death by 32% compared with chemotherapy in patients with a PD-L1 expression of 50% or higher.

Cemiplimab provides another effective option for patients with advanced NSCLC who have high PD-L1 expression, said Sezer. Moreover, findings from the EMPOWER-Lung1 trial have confirmed clinical benefit for this patient population with cemiplimab despite a high crossover rate and broadened inclusion criteria, Sezer explained.

We then spoke with Dr. Stratigos. On February 9, 2021, the FDA approved cemiplimab as the first immunotherapy for use in patients with advanced BCC that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.

The agent was granted full approval for use in patients with locally advanced BCC; it received accelerated approval for use in patients with metastatic BCC.

The regulatory decision was based on data from an open-label, multicenter, non-randomized phase 2 trial, which included a total of 132 patients with unresectable locally advanced BCC or metastatic BCC, either nodal or distant.

Results from the trial showed that cemiplimab elicited a confirmed objective response rate of 21% (95% CI, 8%-41%) in patients with metastatic BCC and 29% (95% CI, 19%-40%) in those with locally advanced BCC.