FDA Approves Libtayo as Monotherapy for Advanced Non-Small Cell Lung Cancer


This is the third approval for Libtayo, following approvals as the first immunotherapy for patients with advanced basal cell carcinoma and as the first systemic treatment for advanced cutaneous squamous cell carcinoma.

The FDA has approved Libtayo (cemiplimab-rwlc) as a monotherapy treatment for patients with first-line advanced non-small cell lung cancer (NSCLC) with a programmed death-ligand 1 (PD-L1) expression of 50% or more.

Lung cancer is the leading cause of cancer-related deaths worldwide, according to a press release. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed worldwide and in the United States, respectively. Approximately 84% of all lung cancers are NSCLC, with 75% diagnosed in advanced stages and an estimated 25% to 30% expected to test positive for PD-L1 in 50% or more of tumor cells.

According to the press release, patients eligible for the treatment must either have metastatic or locally advanced tumors who are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations. This is the third approval for Libtayo, after it was approved earlier this month as the first immunotherapy indicated for patients with advanced basal cell carcinoma, and in 2018 was approved as the first systemic treatment for adults with advanced cutaneous squamous cell carcinoma.

“The approval of Libtayo to treat first-line advanced non-small lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, MD, director of thoracic oncology and co-director of cancer immunotherapy at Columbia University Irving Medical Center, in the press release.

The data supporting the approval are based on an analysis of 710 patients who were randomized to receive treatment in a phase 3 trial. In the patient population with a PD-L1 expression of 50% or more, Libtayo reduced the risk of death by 32% compared to chemotherapy. Due to PD-L1 testing complications, investigators performed an additional prespecified analysis in 563 patients with proven PD-L1 expression of 50% or more and found that Libtayo reduced the risk of death by 43% compared to chemotherapy.

“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation,” Rizvi said. “This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

Safety was assessed in 355 patients in the Libtayo treatment group and 342 patients in the chemotherapy group. Adverse events (AEs) occurring more often in the Libtayo group and in at least 10% of patients included rash and cough. The most frequent serious AEs in at least 2% of patients were pneumonia and pneumonitis, and treatment was permanently discontinued due to AEs in 6% of Libtayo patients.

“We developed Libtayo to deliver clinically meaningful benefits to patients suffering from a diverse range of cancers and to establish a foundation for potential future immunotherapy combinations,” said Israel Lowy, MD, PhD, senior vice president of translational and clinical sciences in oncology at Regeneron, in the release. “Today’s approval continues to support this vision.”


FDA Approves Libtayo (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ³50% [news release]. Regeneron; February 22, 2021. https://investor.regeneron.com/index.php/news-releases/news-release-details/fda-approves-libtayor-cemiplimab-rwlc-monotherapy-patients-first. Accessed February 22, 2021.

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