Akeso announced on November 4, 2026, that China's National Medical Products Administration (NMPA) granted priority review to ivonescimab in combination with chemotherapy for the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC).¹ The designation is expected to accelerate the regulatory review of the indication in China.¹ Ivonescimab is a programmed cell death protein 1 (PD-1)/vascular endothelial growth factor (VEGF) bispecific antibody developed by Akeso.¹
Key facts
- Drug: ivonescimab (PD-1/VEGF bispecific antibody; Akeso)
- Action: NMPA priority review (China)
- Indication: first-line locally advanced or metastatic biliary tract cancer
- Regimen: ivonescimab plus gemcitabine and cisplatin
- Pivotal trial: HARMONi-GI1 (NCT06591520); phase 3; 682 patients
- Overall survival: 14.9 vs 12.1 months (HR, 0.75)
- Comparator: durvalumab plus chemotherapy
- US development: phase 2/3 EA2251 (Summit/ECOG-ACRIN)
- Partner: Summit Therapeutics (ex-China rights; up to $5 billion)
The submission is supported by the phase 3 HARMONi-GI1 trial (NCT06591520), in which ivonescimab plus chemotherapy improved survival compared with durvalumab plus chemotherapy, the current global standard for first-line BTC.¹
What did HARMONi-GI1 show?
The randomized, double-blind, multicenter trial randomized 682 patients 1:1 to ivonescimab or durvalumab, each with gemcitabine and cisplatin.² At a prespecified interim analysis reviewed by an independent data monitoring committee, the trial met its primary endpoint of overall survival (OS).¹,² Median OS was 14.9 months with ivonescimab vs 12.1 months with durvalumab (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.61-0.92; one-sided p=.0031).²
The trial also met its key secondary endpoints.¹ Median progression-free survival was 8.4 months vs 5.8 months (HR, 0.61; 95% CI, 0.51-0.72; one-sided p<.0001), and the objective response rate was 53.8% vs 32.5% (p<.0001).² The results were presented in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Presidential Symposium in October 2026.¹ According to Akeso, HARMONi-GI1 is the first phase 3 trial in BTC to show a statistically significant OS benefit against the established programmed cell death ligand 1 (PD-L1) inhibitor plus chemotherapy standard of care.¹
Durvalumab plus gemcitabine and cisplatin became a first-line standard for advanced BTC based on the phase 3 TOPAZ-1 trial.³
How does ivonescimab work?
Ivonescimab is a bispecific antibody that combines immuno-oncology and anti-angiogenesis mechanisms in a single molecule, targeting PD-1 and VEGF.¹ Akeso describes it as the first approved bispecific antibody to pair these mechanisms and the first therapy to show positive results in a phase 3 head-to-head study against pembrolizumab.¹ The therapy is approved in China for non-small cell lung cancer but is not approved in the United States or Europe.
