FDA Approves Frontline Cemiplimab-rwlc for Advanced Lung Cancer


The FDA approved single-agent frontline cemiplimab-rwlc (Libtayo) for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a PD-L1 expression of 50% or greater.

The FDA approved frontline cemiplimab-rwlc (Libtayo) monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a PD-L1 expression of 50% or greater, according to Sanofi, the manufacturer of the PD-1 inhibitor.

To be eligible for treatment with cemiplimab-rwlc, patients must not only have high PD-L1 expression in their tumor, as determined by an FDA-approved test, but they also must have metastatic or locally advanced tumors that are not eligible for surgical resection or definitive chemoradiation. Moreover, the disease must not harbor EGFR, ALK, or ROS1 aberrations.

“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,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of thoracic oncology, and co-director of cancer immunotherapy at Columbia University Irving Medical Center, as well as a steering committee member of the trial, in a statement.

The approval was based on findings from the phase 3 EMPOWER-Lung 1 trial, published in The Lancet, which included 356 eligible patients who were given cemiplimab-rwlc every 3 weeks at 350 mg and a control group of 354 patients who were given chemotherapy.

Average overall survival was 22 months in the cemiplimab-rwlc arm, compared to 14 months in the chemotherapy arm. Additionally, progression-free survival, as assessed by a Blinded Independent Central Review was 6.2 months for patients receiving cemiplimab-rwlc and 5.6 months in the chemotherapy arm. More than 70% of patients on the trial crossed over to cemiplimab-rwlc after progressing on chemotherapy. The PD-1 inhibitor reduced the risk of death by 32%.

“Libtayo has demonstrated an impressive level of efficacy in advanced NSCLC with at least 50% PD-L1expression in its pivotal trial,” said Ahmet Sezer, MD, professor in the Department of Medical Oncology at Başkent University in Adana, Turkey and a trial investigator.

“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,” Sezer said.

Cemiplimab-rwlc also improved outcomes for patients whose tumors had less than 50% PD-L1, reducing risk of death by 43% in this patient population compared to chemotherapy.

“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 Peter C. Adamson, MD, global development head, oncology and pediatric innovation at Sanofi. "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.”


Sanofi. FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%. https://www.globenewswire.com/news-release/2021/02/22/2179862/0/en/FDA-approves-Libtayo-cemiplimab-rwlc-monotherapy-for-patients-with-first-line-advanced-non-small-cell-lung-cancer-with-PD-L1-expression-of-50.html Feb. 22, 2021. Accessed Feb22, 2021.

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