FDA Approves Front-Line Libtayo for Advanced Non-Small Cell Lung Cancer Subset

The Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (a tumor proportion score of 50% or greater).

According to a press release from Sanofi, the manufacturer of the drug, this approval is for patients who either have metastatic or locally advanced tumors who are not eligible for surgical resection or chemoradiation. Their tumors must also not have EGFR, ALK or ROS1 aberrations.

“The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease,” said Dr. Naiyer Rizvi, Price Family Professor of Medicine, director of thoracic ooncology and co-director of cancer immunotherapy at Columbia University Irving Medical Center, as well as a steering committee member of the trial, in the release. “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. This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

This is the third FDA approval for Libtayo, including indications for subsets of patients with advanced basal cell carcinoma and advanced cutaneous squamous cell carcinoma.

According to trial investigator, Dr. Ahmet Sezer, professor in the Department of Medical Oncology at Başkent University in Adana, Turkey, Libtayo demonstrated an impressive efficacy in its pivotal trial. “As published in The Lancet, 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. 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.”

This approval is the result of a phase 3 trial of 710 patients who were randomized to receive treatment with Libtayo or chemotherapy. The trial demonstrated that Libtayo reduced the risk of death by 32% compared to chemotherapy. An additional analysis of 563 patients with proven PD-L1 expression of 50% or higher found that Libtayo reduced the risk of death by 43% compared to chemotherapy.

Side effects to Libtayo, which at least 10% of patients experienced during clinical trials, include rash (15%) and cough (11%). The most frequent serious side effects that occurred in at least 2% of patients were pneumonia (5%) and pneumonitis (2%). Six percent of patients discontinued treatment due to side effects, which included pneumonitis, pneumonia, ischemic stroke and increased aspartate aminotransferase.

Immune-mediated side effects, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo.

“With this third approval for Libtayo, we are proud to deliver on our ambition to bring our PD-1 inhibitor to patients in need with difficult-to-treat cancers, such as advanced non-small cell lung cancer," said Dr. Peter C. Adamson, global development head of oncology and pediatric innovation at Sanofi, in the press release. "As the leading cause of cancer deaths globally, the need for additional therapeutic options in advanced NSCLC is clear. Libtayo allows physicians to further optimize treatment of these patients whose tumors have high expression of PD-L1. We thank all of the trial investigators, patients and their caregivers who helped make this milestone possible.”