Akeso: Ivonescimab + Chemotherapy Beats PD-1 + Chemotherapy, OS Significantly Positive

At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the landmark positive overall survival (OS) results from the Phase III HARMONi-6/AK112-306 study of Akeso’s global first-in-class PD-1/VEGF bispecific antibody ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) were presented in the Plenary Session. According to an Akeso press release, HARMONi-6 is the first study of a Chinese-originated first-in-class drug to be featured in the ASCO Plenary Session in the Society’s 61-year history. The study results were also published simultaneously in The Lancet, a leading international medical journal.

The study results showed that ivonescimab plus chemotherapy significantly prolonged OS compared with tislelizumab plus chemotherapy. As of the data cutoff date of February 27, 2026, with a median follow-up of 21.36 months: the risk of death was reduced by 34%, and ivonescimab plus chemotherapy demonstrated a significant OS benefit. Previously, at a pre-specified interim analysis of progression-free survival (PFS), ivonescimab plus chemotherapy had already achieved a clinically meaningful and statistically significant PFS positive result compared with tislelizumab plus chemotherapy, with a median PFS of 11.1 months (vs 6.9 months in the control group), HR=0.60 (95% CI: 0.46–0.78), P<0.0001.

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