BioNTech posts mid-stage win for mRNA cancer drug with Regeneron’s Libtayo

BioNTech (NASDAQ:BNTX) announced Tuesday that its mRNA-based cancer therapy BNT111, in combination with Regeneron’s (NASDAQ:REGN) anti-PD-1 therapy, Libtayo (cemiplimab), succeeded in a Phase 2 trial for patients with melanoma, a type of skin cancer.

Citing topline data from the study, the company said BNT111 plus cemiplimab reached the primary endpoint, leading to a statistically significant improvement in tumor responses ((overall response rate)).

While both drugs as monotherapy indicated clinical activity, the German vaccine maker said that the ORR data linked to cemiplimab was in line with historical findings related to cancer drugs known as anti-PD-L1 or anti-CTLA-4 agents in these patients.

As for safety, the drug combo was well tolerated, with a tolerability profile consistent with data from prior trials.

The international trial named BNT111-01 enrolled patients with unresectable stage III or IV melanoma whose cancer had progressed after anti-PD-L1-containing therapy.

The company is advancing the study as planned to generate data on secondary endpoints for which the results were not mature at the time of the analysis.