Summit Therapeutics Inc. (NASDAQ: SMMT) announced today the launch of a new global Phase III study, HARMONi‑GI3, marking the first expansion of its ivonescimab program beyond non‑small cell lung cancer. The trial will evaluate ivonescimab plus chemotherapy versus bevacizumab plus chemotherapy as first‑line therapy in patients with unresectable metastatic colorectal cancer (CRC).
The HARMONi‑GI3 study is designed to enroll approximately 600 patients, with clinical sites planned to activate in the United States before the end of 2025. The primary endpoint is progression‑free survival, and the study will compare the novel bispecific antibody to the current standard of care for this patient population. The trial’s design is informed by encouraging Phase II data presented at ESMO 2024, which showed an objective response rate of 81.8% and a disease‑control rate of 100% in 22 patients treated with ivonescimab plus FOLFOXIRI. No treatment‑emergent adverse events led to permanent discontinuation of ivonescimab in that cohort.
MSS colorectal cancer represents a large unmet need, with an estimated 48,000 patients diagnosed annually who lack effective first‑line options beyond bevacizumab plus chemotherapy. By targeting this population, Summit aims to capture a significant share of a market that has historically been refractory to PD‑1 inhibitors. The expansion also diversifies ivonescimab’s pipeline, potentially accelerating regulatory and commercial timelines and enhancing the company’s long‑term revenue prospects.
The announcement underscores Summit’s strategic shift toward oncology and its commitment to advancing ivonescimab across multiple solid tumor indications. The new Phase III program in CRC is a key milestone that could broaden the therapeutic impact of the bispecific antibody and strengthen Summit’s position in the competitive oncology landscape.
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