Summit Therapeutics has expanded its clinical programme for ivonescimab with the Phase II/III HARMONi-GU1 study to assess its use in patients with previously untreated locally advanced or metastatic urothelial carcinoma, the most common form of bladder cancer.
HARMONi-GU1 will compare ivonescimab, an investigational bispecific antibody, in combination with enfortumab vedotin (EV), an antibody-drug conjugate, against the current standard of care combination of pembrolizumab and EV.
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The multi-regional, global, randomised trial will include around 800 participants through the Phase III stage. Activation of clinical trial sites is expected to begin later this year.
The initial Phase II stage will determine the recommended Phase III dose of ivonescimab when used alongside EV. The principal objectives for the Phase III portion are to measure progression-free survival and overall survival.
Summit Therapeutics president and co-CEO Dr Maky Zanganeh said: “The initiation of HARMONi-GU1 marks another important step in the continued expansion of our global ivonescimab development programme into additional tumour types where significant unmet need remains.
“Because both angiogenesis and immune evasion are important features of urothelial carcinoma biology, we believe ivonescimab’s tetravalent, intentionally-engineered PD-1 / VEGF bispecific mechanism offers a compelling scientific rationale for evaluation in bladder cancer.”
The company’s development and collaboration activities for ivonescimab cover several cancer types, including colorectal, kidney, lung and pancreatic.
Four Phase III trials for ivonescimab sponsored by Akeso in China, all in non-small cell lung cancer (NSCLC), have reported data. Across all clinical efforts, ivonescimab is currently being assessed in 16 Phase III studies.
Also referred to as SMT112 within Summit’s licensed territories, ivonescimab targets both programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF).
It was engineered by Akeso and has so far been administered to more than 4,000 patients in clinical research worldwide, with the company reporting usage in over 70,000 individuals in commercial settings in China.
Last month, Summit Therapeutics released more Phase III trial data for ivonescimab in NSCLC as it awaits a decision from US regulators.
