Clinical TrialAug 5, 2026, 07:37 AM
Summit Therapeutics Expands Ivonescimab Program to Bladder Cancer
AI Summary
Summit Therapeutics Inc. announced the expansion of its global registration-enabling clinical development program for ivonescimab into urothelial carcinoma (bladder cancer). The company is initiating the global, multi-regional Phase II/III HARMONi-GU1 trial, which will evaluate ivonescimab plus enfortumab vedotin (EV) against pembrolizumab plus EV as first-line therapy for locally advanced or metastatic urothelial carcinoma. Global clinical trial site activations are planned to commence by Q4 2026, further broadening ivonescimab's potential applications.
Key Highlights
- Initiated global Phase II/III HARMONi-GU1 trial for ivonescimab in urothelial carcinoma.
- HARMONi-GU1 evaluates ivonescimab + enfortumab vedotin (EV) vs. pembrolizumab + EV.
- Trial targets first-line therapy for locally advanced or metastatic urothelial carcinoma.
- Global clinical trial site activations for HARMONi-GU1 to begin by Q4 2026.
- HARMONi-GU1 aims to enroll approximately 800 patients through Phase III.
- Ivonescimab is now being evaluated in 16 Phase III clinical trials across multiple tumor types.
- Four Phase III ivonescimab trials in NSCLC have shown positive data to date.
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