Ivonescimab

Summit Therapeutics plans a Q4 2025 BLA submission for ivonescimab plus chemotherapy in EGFR-mutated NSCLC based on positive Phase III HARMONi trial results. A new Phase III CRC study (HARMONi-GI3) will begin, with more Phase III trials planned. HARMONi showed a 48% reduction in disease progression risk in NSCLC and the HARMONi-6 study in China demonstrated a 40% reduction in risk in squamous NSCLC compared to tislelizumab plus chemotherapy. The HARMONi-3 study will analyze squamous and non-squamous NSCLC cohorts separately.

Summit Therapeutics announced positive Phase III HARMONi trial data for ivonescimab plus chemotherapy in EGFR-mutated NSCLC patients who progressed after EGFR-TKI treatment. While the primary analysis showed a positive OS trend (HR=0.79, p=0.057), longer follow-up of Western patients demonstrated improved OS (HR=0.78, p=0.0332). North American patients showed a promising OS HR of 0.70. Ivonescimab’s safety profile was consistent with prior studies. A conference call will be held September 8, 2025, to discuss these findings.