Sanofi, Regeneron's Libtayo bags EU approvals in lung cancer, basal cell carcinoma

Sanofi and Regeneron Pharmaceuticals said Friday that Libtayo (cemiplimab) gained approval from the European Commission for certain patients with non-small-cell lung cancer in the first-line setting, as well as for adults with locally advanced or metastatic basal cell carcinoma (BCC). The PD-1 inhibitor is now authorised in Europe for three advanced cancers, having gained clearance in 2019 for use in patients with cutaneous squamous cell carcinoma.

The new NSCLC indication is for adults whose tumour cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. Sanofi and Regeneron indicated that patients must have metastatic or locally advanced NSCLC, and not be candidates for definitive chemoradiation. Meanwhile, in BCC, Libtayo was authorised to treat adults who have progressed on or are intolerant to a hedgehog pathway inhibitor, making it the first immunotherapy cleared in this indication.

Cuts mortality risk by 32% in lung cancer

The drugmakers noted approval in advanced NSCLC was based on data from the Phase III EMPOWER-Lung 1 study showing that Libtayo reduced the risk of death by 32% and extended median overall survival (OS) by 8 months compared to chemotherapy. In the trial, the median OS was 22 months for Libtayo and 14 months for chemotherapy.

"We are anticipating results from our ongoing Phase III trial of Libtayo plus chemotherapy in patients with advanced [NSCLC]," added Peter Adamson, Sanofi's global development head for oncology.

Nearly third of BCC patients respond

Meanwhile, the companies noted that approval in BCC was supported by results from a Phase II trial showing that Libtayo was associated with an objective response rate (ORR) of 32%, including a complete-response rate of 7%, in patients with locally advanced disease. Further, in those with metastatic BCC, the ORR was 29%, including a complete-response rate of 3%.

"Since its launch in Europe just two years ago, Libtayo has redefined the standard of care for advanced [cutaneous squamous cell carcinoma] and has the potential to do the same in advanced BCC," commented Adamson.

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