Chinese biotechnology company Akeso said a final analysis of its Phase III HARMONi-A study showed that ivonescimab, a bispecific antibody targeting PD-1 and VEGF, significantly extended overall survival when added to chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer whose disease had progressed after tyrosine-kinase inhibitor therapy. The company described the benefit as both statistically significant and clinically meaningful, marking the first time the therapy has met an overall-survival goal. Earlier readouts from HARMONi-A showed ivonescimab plus chemotherapy delivered a 54% progression-free survival improvement over chemotherapy alone, with median PFS of 7.1 months versus 4.8 months. Detailed overall-survival data were not released and are expected to be presented at a forthcoming medical conference. Ivonescimab secured Chinese approval last year for the same second-line lung-cancer setting and more recently as a first-line option for PD-L1–positive disease. The new survival results are expected to bolster regulatory filings outside China, which Akeso’s partner Summit Therapeutics is leading. If approved in the United States or Europe, ivonescimab would compete directly with Merck’s blockbuster PD-1 inhibitor Keytruda, the current standard of care. Some analysts cautioned that clarity on hazard ratios and long-term follow-up from the separate global HARMONi study will be needed to confirm the magnitude and durability of the survival benefit. Nevertheless, the latest data strengthen ivonescimab’s profile as one of the few emerging immuno-oncology agents to show a definitive survival advantage in this hard-to-treat patient population.