Akeso, Inc. (AKESF,9926.HK) announced that China's National Medical Products Administration has approved a significant label update for its first-in-class PD-1/VEGF bispecific antibody, ivonescimab. The update incorporates final analysis data from the AK112-301/HARMONi-A study, which demonstrated statistically significant and clinically meaningful dual benefits in both progression-free survival (PFS) and overall survival (OS) for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) who had progressed after EGFR-TKI therapy.
The HARMONi-A trial is notable as the world's first Phase III immunotherapy study in EGFR-TKI-resistant nsq-NSCLC to show meaningful improvements in both co-primary endpoints, PFS and OS. It is also the first randomized, double-blind Phase III trial in this setting to report positive outcomes for both survival endpoints concurrently, underscoring the benefits of Akeso's combined immunotherapy and anti-angiogenic approach.
Final OS analysis, with a median follow-up of 32.5 months, confirmed that ivonescimab plus chemotherapy significantly improved survival compared to chemotherapy alone. At 77% data maturity, the combination lowered the risk of death by 26% and reduced the risk of disease progression or death by 54%, extending median PFS from 4.8 to 7.1 months. The long-term safety profile remained favorable, with no new safety signals identified and no significant differences in treatment-related adverse events between groups.
Based on these results, ivonescimab received regulatory approval in May 2024 for this indication and was added to China's National Reimbursement Drug List (NRDL) in November 2024, effective January 2025, ensuring broad patient access. In April 2025, ivonescimab also gained approval for the first-line treatment of PD-L1-positive NSCLC, with NRDL inclusion effective January 2026. This provides patients in China with a highly effective, well-tolerated, and durable chemotherapy-free option for first-line NSCLC treatment.
Akeso is trading on the Hong Kong Stock Exchange at HK$127.80, reflecting an increase of HK$7.40 or 6.15%.
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