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A personalized, AI-designed peptide vaccine called EVX-01, combined with pembrolizumab (Keytruda), triggered strong immune responses and impressive tumor control in patients with advanced melanoma. In a phase 2 trial of 16 patients, 75% achieved an objective response — including 25% complete responses — and benefits lasted up to 3 years. Nearly 9 in 10 vaccine targets successfully activated T cells.
A personalized cancer vaccine built by artificial intelligence is showing real promise in advanced melanoma. EVX-01, designed by Evaxion's AI-Immunology platform to target each patient's unique tumor mutations (neoantigens), was combined with the checkpoint inhibitor pembrolizumab in a phase 2 trial. Data presented at the 2026 SITC Annual Meeting showed the combo not only activated the immune system in a highly targeted way but also delivered durable clinical results.
The trial enrolled 16 patients with stage IV or unresectable stage III melanoma who had not previously received checkpoint inhibitor therapy. Patients received pembrolizumab starting at week 0, followed by six EVX-01 priming doses and four booster doses over roughly 1.5 years. Six patients then continued on EVX-01 alone in a one-year extension phase.
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Why it matters: Personalized cancer vaccines have long been a goal of oncology research, and EVX-01's AI-driven design — combined with a proven checkpoint inhibitor — appears to generate both meaningful immune activation and lasting tumor control. If confirmed in larger trials, this approach could represent a new frontier in melanoma treatment.
