Libtayo (cemiplimab) in Combination with Chemotherapy Approved by European Commission for the First-line Treatment of Advanced PD-L1 Positive NSCLC

Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

“Today’s approval considerably expands the number of people in Europe with advanced non-small cell lung cancer who are eligible for Libtayo-based first-line treatment, including those with PD-L1 expression ranges most commonly seen in real-world practice,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “We are proud that Libtayo continues to distinguish itself among PD-1 pathway blockers, as just one of two PD-1 inhibitors to be approved for use across squamous and non-squamous forms of advanced NSCLC in both combination and monotherapy settings. This marks the fifth approval for Libtayo in Europe.”

Lung cancer is the leading cause of cancer death worldwide. In recent years, more than 2.2 million annual new cases have been diagnosed globally. Approximately 80-85% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages.

“The Phase 3 EMPOWER-Lung 3 trial showed significant improvements across primary and key secondary endpoints, including overall survival in the cemiplimab plus chemotherapy arm,” said Prof. Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany. “As a treating physician of this patient population, I welcome a new treatment option for patients in Europe, as we continue to strive for better outcomes for patients with advanced non-small cell lung cancer.”

“With lung cancer being the leading cause of cancer mortality globally, ongoing research is imperative to find more treatment options for people impacted by this disease,” said Anne-Marie Baird, Ph.D., President, Lung Cancer Europe. “This approval highlights continued progress in first-line treatment options for people impacted by advanced lung cancer in Europe.”

Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer. The Libtayo combination was also approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression in November 2022.