Ivonescimab Delivers Overall Survival Wins at WCLC 2026 — First Agent to Beat Pembrolizumab Head-to-Head on OS

Ivonescimab Delivers Overall Survival Wins at WCLC 2026 — First Agent to Beat Pembrolizumab Head-to-Head on OS

At the IASLC World Conference on Lung Cancer 2026 (Seoul, Sept 13–15), Akeso and Summit Therapeutics presented overall survival data that strengthen ivonescimab's challenge to pembrolizumab — and its own FDA prospects ahead of a November 14, 2026 PDUFA date.

HARMONi-2 (China, monotherapy vs pembrolizumab, PD-L1-positive NSCLC): the full OS analysis confirmed the first randomized Phase 3 head-to-head win over Keytruda on survival. Per Akeso: "median OS of 30.8 months versus 22.6 months (HR=0.73; 95% CI: 0.57–0.95; P=0.009), corresponding to a 27% reduction in the risk of death." Akeso states: "HARMONi-2 is the first randomized, double-blind, controlled Phase III clinical study to demonstrate statistically significant positive OS and PFS results versus pembrolizumab.¹" The benefit was most pronounced in PD-L1-high patients (TPS ≥50%: HR=0.58, median OS not reached vs 23.2 months) and squamous histology (HR=0.65) — notably with no apparent increase in bleeding even in centrally-located, cavitary, or vessel-encasing squamous tumors traditionally contraindicated for anti-VEGF therapy.

HARMONi (global, ivonescimab + chemo in EGFR-mutated NSCLC after third-generation TKI): updated data answered the biggest doubt — whether the OS trend holds in Western patients, given the April 2025 primary analysis missed statistical significance (HR 0.79, p=0.057). With June 2026 data cutoff and 23.2 months median follow-up in Western patients: "The updated June 2026 analysis continued to show consistent, favorable OS results, with an OS hazard ratio of 0.76 (95% CI: 0.61 – 0.95; nominal p=0.0151) in the global intention-to-treat (ITT) population. An OS hazard ratio of 0.76 was demonstrated in the western patient subgroup (95% CI: 0.52 – 1.10), which was consistent with the ITT population and Asian subgroup." Median OS: 16.8 vs 14.0 months. Presenting author Antonio Passaro: "Importantly, with longer follow-up, the survival improvement observed in western patients was consistent with the global population, reinforcing the relevance of these results across geographic regions."

Summit's FDA BLA (based on HARMONi in EGFR-mutated NSCLC post-TKI) is under priority review with the Nov 14, 2026 PDUFA date; the global HARMONi-3 (first-line NSCLC) and HARMONi-7 (PD-L1-high monotherapy vs pembrolizumab) readouts remain the decisive tests for the global first-line claim — tracked in Ivonescimab Delivers Overall Survival Wins at WCLC 2026 — First Agent to Beat Pembrolizumab Head-to-Head on OS and the HARMONi-3 topline watch.