Sanofi’s immunotherapy Libtayo gets FDA approval in first line lung cancer

Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients.

The approval in first-line lung cancer, in non-small cell lung cancer patients whose tumours have high PD-L1 expression brings the drug into competition with Merck & Co’s Keytruda (pembrolizumab), which has become the go-to therapy in this disease.

To be eligible for Libtayo, which was developed in partnership with Regeneron, patients must either have metastatic or locally advanced tumours that are not candidates for surgical resection or definitive chemoradiation and the tumours must not have EGFR, ALK or ROS1 mutations.

This third approval for Libtayo follows a Priority Review, which lasts up to six months instead of the standard 10, and is reserved for drugs that represent significant improvements in safety or efficacy in treating serious conditions.

Ahmet Sezer, professor in the Department of Medical Oncology at Başkent University in Adana, Turkey and a trial investigator.

Sezer said: “Libtayo has demonstrated an impressive level of efficacy in advanced NSCLC with at least 50% PD-L1 expression in its pivotal trial.

“As published in The Lancet, in 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.”

The data supporting the Libtayo approval are based on an analysis of 710 patients who were randomized to receive treatment in a phase 3 trial.

Eligible patients were intended to have PD-L1 expression of 50% or higher. In this patient population, Libtayo reduced the risk of death by 32% compared to chemotherapy.

Median overall survival in the Libtayo arm was 18 months, compared with 14 months in the chemotherapy arm.

Median progression-free survival was 8 months in the Libtayo arm, compared with 6 months in the chemotherapy patients.

These figures were based on an analysis of a subset of the randomised population excluding 147 patients whose tumours could not be retested or were later found to have less than 50% PD-L1 expression.

Libtayo was first FDA-approved in late 2018 for advanced cutaneous squamous cell carcinoma, followed by advanced basal cell carcinoma last month.

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