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Phase 3 Trial Demonstrates 65% Response Rate for Bispecific Antibody in Advanced Melanoma

A multicenter phase 3 randomized controlled trial enrolled 420 patients with advanced melanoma who had progressed after prior checkpoint inhibitor therapy, randomly assigning them to receive either the novel bispecific T-cell engager antibody targeting PD-1 and LAG-3 or standard chemotherapy. Responses were evaluated using RECIST criteria, with primary endpoints including objective response rate and progression-free survival. The antibody group achieved a 65% objective response rate, with many responses lasting over 12 months, significantly outperforming chemotherapy. This positions the treatment as a potential second-line option, reducing reliance on toxic chemotherapies and improving outcomes for refractory patients. Published in Nature Medicine on March 7, 2026.