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 HARMONi-GI3 study 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. This expansion follows promising Phase II data presented by Akeso Inc., showing high objective response and disease control rates in combination with chemotherapy.
Why It's Important?
The expansion of ivonescimab into colorectal cancer 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 front-line treatment options. The combination of immunotherapy and anti-angiogenesis in a single molecule may improve treatment outcomes and provide a new standard of care for CRC patients. The success of this trial could lead to broader applications of ivonescimab in other solid tumors, enhancing Summit Therapeutics' position in the oncology market.
What's Next?
Summit Therapeutics plans to activate clinical trial sites in the United States for the HARMONi-GI3 study by the end of 2025. The company will host a conference call to discuss recent updates related to ivonescimab, including data released at the European Society of Medical Oncology (ESMO) Congress. The trial's progression and results will be closely monitored by stakeholders, including healthcare providers and investors, as they could influence future treatment protocols and market dynamics in oncology.
