ESMO 2025 | Phase II trial of BNT111 and cemiplimab in PD-1–refractory melanoma

The BNT-111 was a randomized phase 2 trial that was designed to explore the response rate for the combination of BNT-111 and pembrolizumab compared with historical control assumed as 10%. Then we had two additional arms required from FDA that were calibrator arms, one with BNT-111 monotherapy, the other one with pembrolizumab alone. The study enrolled 184 patients. The response rate from the combination with BNT111 and pembrolizumab was 18.1%. So compared to the 10% it is better and we can say that the trial is positive. Of course it’s positive, exciting, because the population enrolled were a bad population for a vaccine. That means the patients who previously failed a treatment with anti-PD-1, PD-L1, or combination, and were patients with metastatic disease, and also patients with normal LDH. Anyway, there were patients with visceral disease, liver metastases, so that are the patients who wrongly respond to immunotherapy. Having said that, this response seems to be interesting, but what is more interesting, in the monotherapy arm with vaccine, the number of responses was similar, was 17.7% monotherapy, with 13% of patients with complete remission, with 58% of patients with disease control benefit, with a flat part of the progression-free survival curve and overall survival curve. That means that the patients at 3 years are still progression-free, 25% of patients, or still alive, 35% of patients. So the results look really promising because if the vaccine immunotherapy showed good results in a bad population, to go in early phases or in first-line metastatic disease, probably the efficacy can be better.

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