Akeso has announced that China’s National Medical Products Administration (NMPA) has approved a major label update for ivonescimab, PD-1/VEGF bispecific antibody. The update incorporates final analysis data from the Phase III AK112-301/HARMONi-A study.

The HARMONi-A trial evaluated ivonescimab in combination with chemotherapy in patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) who had progressed after EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy. The study demonstrated statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS), compared with chemotherapy alone.

According to Akeso, HARMONi-A is the world’s first Phase III immunotherapy study in EGFR-TKI-resistant nsq-NSCLC to achieve positive results across both co-primary endpoints of PFS and OS. It is also the first randomized, double-blind Phase III trial in this setting to report concurrent survival benefits, underscoring the potential of Akeso’s immunotherapy and anti-angiogenic combination strategy.

Final OS analysis, conducted with a median follow-up of 32.5 months, showed that ivonescimab combination therapy reduced the risk of death by 26 percent compared with chemotherapy alone. The regimen also lowered the risk of disease progression or death by 54 percent, extending median PFS from 4.8 months to 7.1 months.

The long-term safety profile of the ivonescimab combination remained favourable, with no new safety signals identified. Rates of common treatment-related adverse events were comparable between the treatment and control groups.

Based on earlier positive results from the HARMONi-A study, ivonescimab was initially approved by the NMPA in May 2024 for this indication and was added to China’s National Reimbursement Drug List (NRDL) in November 2024, effective January 1, 2025, improving patient access nationwide.