Positive top-line results for BioNTech’s BNT111

German biotech BioNTech (Nasdaq: BNTX) edged up 2.2% to $88.80 in pre-market activity, following the release of positive top-line data from the ongoing Phase II clinical trial in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment.

The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo (cemiplimab), an anti-PD-1 monoclonal antibody being developed by Regeneron (Nasdaq: REGN) and assesses the two single agents alone. The companies are researching the combination under a 2020 collaboration.

BioNTech noted that the trial met its primary efficacy outcome measure, demonstrating a statistically-significant improvement in ORR in patients treated with BNT111 in combination with cemiplimab as compared to historical control in this indication and treatment setting. Both randomized monotherapy arms showed clinical activity. The ORR in the cemiplimab monotherapy arm was in line with the historical control of anti-PD-(L)1 or anti-CTLA-4 treatments in this patient group. The treatment was well tolerated and the safety profile of BNT111 in combination with cemiplimab in this trial was consistent with previous clinical trials assessing BNT111 in combination with anti-PD-(L)1-containing treatments. The Phase II trial will continue as planned to further assess the secondary endpoints, which were not mature at the time of the primary analysis.