Sanofi, Regeneron's Libtayo nabs FDA approval in first-line NSCLC

Sanofi and Regeneron Pharmaceuticals announced that the FDA approved Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC) whose tumours have high PD-L1 expression, defined as a tumour proportion score ≥50%. The clearance comes less than two weeks after the PD-1 inhibitor was authorised in the US as the first immunotherapy for certain patients with advanced basal cell carcinoma (BCC).

The latest approval marks the third indication for Libtayo in the US, having been cleared in 2018 as the first systemic treatment for adults with advanced cutaneous squamous cell carcinoma (CSCC) that is locally advanced or metastatic and who are not candidates for curative surgery or curative radiation. Israel Lowy, senior vice president of translational and clinical sciences, oncology at Regeneron, remarked "Libtayo has already changed the treatment paradigm for certain patients with advanced [CSCC] and is poised to do the same for advanced [BCC]. Now, Libtayo has the opportunity to make a meaningful difference for the many US patients battling advanced NSCLC."

Specifically, the new indication is for patients who 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 aberrations. Data supporting approval come from the Phase III EMPOWER-Lung 1 trial, which showed that Libtayo reduced the risk of death by 32% compared to chemotherapy, rising to 43% in those with proven PD-L1 expression of ≥50% as determined by an FDA-approved assay.

Libtayo, which generated US sales of $74.1 million in the fourth quarter of 2020, is also being investigated in pivotal trials in NSCLC, together with chemotherapy, and cervical cancer, as well as in combination studies for both solid tumours and blood cancers. The European Medicines Agency is currently assessing regulatory submissions for Libtayo in advanced NSCLC with ≥50% PD-L1 expression and locally advanced BCC following treatment with a hedgehog pathway inhibitor, with decisions expected by mid-2021.

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