The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) and chemotherapy combination as the first-line treatment for advanced non-small cell lung cancer (NSCLC).
The combination therapy has been approved to treat advanced NSCLC in adult patients with no EGFR, ALK or ROS1 aberrations.
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It is also approved for patients with either metastatic or locally advanced tumours that will not respond to surgical resection or definitive chemoradiation.
Patients may receive this therapy regardless of PD-L1 expression or tumour histology.
The regulatory approval is based on results obtained from the international Phase III EMPOWER-Lung 3 trial.
In the study, Libtayo and a physician’s choice of platinum-doublet chemotherapy were compared to platinum-doublet chemotherapy alone.
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By GlobalDataApproximately 466 patients with locally advanced or metastatic NSCLC with no ALK, EGFR or ROS1 aberrations and irrespective of PD-L1 expression or tumour histology, were enrolled in the study.
Regeneron Oncology, Translational and Clinical Sciences, senior vice-president Israel Lowy said: “Libtayo is now approved for extending the survival of patients with advanced non-small cell lung cancer as both a monotherapy in high PD-L1 expressors and in combination with chemotherapy irrespective of PD-L1 expression levels, achieving a high bar that has only been met by one other PD-1 targeting agent.
“With this FDA approval, Libtayo can expand its role as a key treatment option for advanced non-small lung cancer, in addition to serving as a standard-of-care for two advanced non-melanoma skin cancers.
“We are committed to investigating Libtayo through ongoing trials as a monotherapy and as a backbone of combination treatments in multiple cancers.”
Musculoskeletal pain, fatigue, alopecia, nausea, peripheral neuropathy and decreased appetite are the most common adverse reactions.
