$SMMT (SUMMIT THERAPEUTICS) — 8-K: Summit adds Phase II/III bladder cancer trial for ivonescimab, site activations planned by Q4 2026

Summit Therapeutics is expanding ivonescimab into urothelial carcinoma with the global Phase II/III HARMONi-GU1 trial, evaluating ivonescimab plus enfortumab vedotin versus pembrolizumab plus enfortumab vedotin in first-line locally advanced or metastatic disease. The study intends to enroll approximately 800 patients in Phase III, with primary endpoints of progression-free survival and overall survival. Global site activations are planned to begin by Q4 2026, adding to 16 ongoing Phase III trials across multiple tumor types.

Summit Therapeutics is expanding ivonescimab into urothelial carcinoma with the global Phase II/III HARMONi-GU1 trial, evaluating ivonescimab plus enfortumab vedotin versus pembrolizumab plus enfortumab vedotin in first-line locally advanced or metastatic disease. The study intends to enroll approximately 800 patients in Phase III, with primary endpoints of progression-free survival and overall survival. Global site activations are planned to begin by Q4 2026, adding to 16 ongoing Phase III trials across multiple tumor types.