Biopharmaceutical oncology company Summit Therapeutics Inc (NASDAQ: SMMT) reported on Wednesday that it has expanded the global clinical development programme for its investigational bispecific antibody ivonescimab by launching the Phase II/III HARMONi-GU1 trial in first-line bladder cancer, marking its first global registrational study in a genitourinary cancer.

Global clinical trial site activations are scheduled to begin by the fourth quarter of 2026.

HARMONi-GU1 will compare ivonescimab plus enfortumab vedotin with pembrolizumab plus enfortumab vedotin as first-line treatment for previously untreated locally advanced or metastatic urothelial carcinoma. The study is expected to enrol around 800 patients through Phase III, with progression-free survival and overall survival as the primary endpoints.

With the addition of HARMONi-GU1, ivonescimab is now being evaluated in 16 Phase III clinical trials across multiple tumour types and treatment settings. Summit said four Phase III studies have reported positive data in non-small cell lung cancer.