HONG KONG – – November 05, 2026 -- China's National Medical Products Administration (NMPA) has granted Priority Review to Akeso's ivonescimab plus chemotherapy for first-line locally advanced or metastatic biliary tract cancer (BTC), a designation expected to accelerate the subsequent regulatory review in China.
HARMONi-GI1 Phase III trial beats durvalumab regimen on overall survival
In the randomized, double-blind, multicenter HARMONi-GI1 study (AK112-309), ivonescimab plus chemotherapy was compared with durvalumab plus chemotherapy, the current global first-line standard in BTC. A prespecified interim analysis reviewed by the Independent Data Monitoring Committee showed the trial met its primary endpoint of overall survival (OS). The improvement over the control arm was statistically significant and clinically meaningful. The study also met all key secondary endpoints, including progression-free survival and objective response rate.
Akeso says HARMONi-GI1 is the first Phase III BTC trial to show a statistically significant OS benefit against the established PD-L1 inhibitor plus chemotherapy standard. The data were presented as a Late-Breaking Abstract in an oral presentation at the ESMO Presidential Symposium in October 2026.
Summit and ECOG-ACRIN launch a registration-enabling BTC study in the US
On October 21, 2026, Summit announced a clinical trial collaboration with ECOG-ACRIN Cancer Research Group. The registration-enabling Phase II/III study, EA2251, will compare ivonescimab plus chemotherapy against pembrolizumab or durvalumab plus chemotherapy in first-line advanced BTC.
Akeso runs more than 17 Phase III ivonescimab studies worldwide
Ivonescimab is a PD-1/VEGF bispecific antibody developed by Akeso. The company says it is the world's first approved bispecific combining immuno-oncology and anti-angiogenesis mechanisms, and the first therapy to show positive Phase III results head-to-head against pembrolizumab.
The global program includes seven international multi-regional registrational Phase III trials and seven head-to-head studies against PD-1/PD-L1 therapies. Eight registrational or Phase III studies are in lung cancer. Other first-line trials cover MSS/pMMR colorectal cancer, PD-L1-positive head and neck squamous cell carcinoma (combined with ligufalimab versus pembrolizumab), triple-negative breast cancer, pancreatic cancer and urothelial carcinoma (versus pembrolizumab plus a Nectin-4 ADC).
Akeso has out-licensed exclusive development and commercialization rights to ivonescimab in the United States, Canada, South America, Europe, the Middle East, Africa and Japan to Summit Therapeutics. The agreement has a total potential value of up to US$5 billion.