Summit Therapeutics’ bispecific antibody ivonescimab has achieved landmark results in the pivotal Phase 3 HARMONi-6 trial, demonstrating superior efficacy in combination with chemotherapy for patients with advanced non-small cell lung cancer (NSCLC).
The trial, conducted in China alongside partner Akeso, showed that ivonescimab plus chemotherapy reduced the risk of disease progression or death by 40% compared to the combination of Tevimbra (a PD-1 inhibitor) and chemotherapy, providing a median progression-free survival of 11 months against 7 months for the comparator group. Ivonescimab, a dual-acting agent that simultaneously targets PD-1 and VEGF, leverages immune checkpoint inhibition and vascular growth suppression to address tumor escape mechanisms—notably in squamous cell NSCLC, where anti-VEGF therapies have previously failed to show meaningful benefit. The new data sparked renewed hopes that ivonescimab may rival or surpass Merck’s Keytruda as part of first-line treatment regimens.
Summit and Akeso announced intentions to submit a Biologics License Application (BLA) to the FDA in late 2025, positioning ivonescimab as a promising candidate for patients struggling with hard-to-treat lung cancers globally. Clinicians and industry experts note that this landmark trial result reflects a major advance for bispecific antibodies in solid tumor oncology, with Summit poised to expand trials to additional cancer types in the near future.
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