Summit Therapeutics announced the expansion of its global clinical development program for its investigational bispecific antibody, ivonescimab, into urothelial carcinoma (bladder cancer). The company is initiating a global, multi-regional Phase II/III clinical trial, named HARMONi-GU1, for this new indication.
Key Details
- Trial: The HARMONi-GU1 study will evaluate ivonescimab plus the antibody-drug conjugate enfortumab vedotin (EV) as a first-line therapy for patients with previously untreated locally advanced or metastatic urothelial carcinoma.
- Comparison: The treatment will be compared against the current standard of care, pembrolizumab plus EV.
- Timeline & Enrollment: Global clinical trial site activations are planned to begin by Q4 2026, and the study intends to enroll approximately 800 patients through its Phase III portion.