BioNTech, Regeneron Expand Libtayo Partnership to Treat NSCLC

BioNTech is evaluating its messenger RNA-based cancer vaccine candidate, BNT116, in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) as a treatment for patients with nonsmall-cell lung cancer (NSCLC).

Under the expanded partnership, the companies will launch phase 1/2 clinical trials assessing the combination as a first-line therapy in patients with advanced NSCLC. A separate phase 1 trial testing the combination in NSCLC subpopulations is also in the works.

The new pact follows the companies’ existing collaboration evaluating BNT111 plus Libtayo as a treatment for patients with advanced melanoma.

The FDA granted BNT111 a Fast-Track designation in November 2021.