BLA Submission

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.