What's Happening?
Summit Therapeutics Inc. has announced the expansion of its Phase III clinical development program for ivonescimab, a novel bispecific antibody, into colorectal cancer (CRC) with the initiation of the global Phase III HARMONi-GI3 trial. Ivonescimab combines
immunotherapy effects via PD-1 blockade with anti-angiogenesis effects by blocking VEGF. The trial will evaluate ivonescimab plus chemotherapy against bevacizumab plus chemotherapy as first-line therapy in patients with unresectable metastatic CRC. Clinical trial sites are expected to activate in the United States by the end of the year, aiming to enroll approximately 600 patients. The primary endpoint is progression-free survival.
Why It's Important?
The expansion of ivonescimab into CRC represents a significant development in cancer treatment, particularly for patients with microsatellite stable colorectal cancer (MSS CRC), where existing PD-1 inhibitors have shown limited efficacy. This trial could potentially offer a new therapeutic option for patients with few available treatments, addressing a global unmet need. The success of ivonescimab in previous trials, such as its combination with FOLFOXIRI chemotherapy, suggests it may improve outcomes for CRC patients, potentially setting a new standard of care.
What's Next?
Summit Therapeutics plans to open clinical trial sites in the United States for the Phase III study by the end of 2025. The company will host a conference call to discuss updates related to ivonescimab, including data released at ESMO, on October 20, 2025. The trial's results could influence future treatment protocols for CRC and potentially lead to regulatory approval if successful.
