Summit expands ivonescimab into bladder cancer with Phase II/III HARMONi-GU1 trial

Summit Therapeutics Inc.

Ivonescimab plus enfortumab vedotin (EV) vs pembrolizumab plus EV as 1L therapy for locally advanced/metastatic urothelial carcinoma.
Phase II/III trial aims to enroll ~800 patients; Phase III endpoints are PFS and OS.
Global site activations planned to begin by Q4 2026.
Ivonescimab now in 16 Phase III trials across multiple tumor types including lung, colorectal, and bladder.

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