BioNTech’s BNT111 meets primary Phase 2 endpoint in advanced melanoma

BioNTech (BNTX) announced positive topline data from the ongoing Phase 2 clinical trial in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-L-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo, an anti-PD-1 monoclonal antibody being developed by Regeneron (REGN), and assesses the two single agents alone. 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 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-containing treatments. The Phase 2 trial will continue as planned to further assess the secondary endpoints, which were not mature at the time of the primary analysis. BioNTech and Regeneron plan to present data from this trial at a forthcoming medical conference and to submit these data for publication in a peer reviewed scientific journal.