On November 4, 2026 Akeso, Inc. (HKEX: 9926.HK) reported that ivonescimab in combination with chemotherapy for the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC) has been granted Priority Review by China’s National Medical Products Administration (NMPA). The Priority Review designation is expected to accelerate the subsequent regulatory review process for this indication in China.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In the randomized, double-blind, multicenter Phase III registrational study HARMONi-GI1 (AK112-309), ivonescimab plus chemotherapy demonstrated superior survival benefit for patients versus durvalumab plus chemotherapy, the current global standard for the first-line treatment of BTC. In a prespecified interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), HARMONi-GI1 met its primary endpoint of overall survival (OS), with the ivonescimab plus chemotherapy arm demonstrating statistically significant and clinically meaningful improvement over the control arm. The trial also met all key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR).
The HARMONi-GI1 results were presented as a Late-Breaking Abstract in an oral presentation at the ESMO (Free ESMO Whitepaper) Presidential Symposium in October 2026. HARMONi-GI1 is the first Phase III trial in BTC to show statistically significant overall survival benefit against the established PD-L1 inhibitor plus chemotherapy standard of care.
On October 21, 2026, Summit announced a clinical trial collaboration with ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate the safety and efficacy of ivonescimab with chemotherapy compared to pembrolizumab or durvalumab plus chemotherapy in a registration-enabling Phase II/III study (EA2251), in the first-line treatment of patients with advanced BTC.
About Ivonescimab
Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody independently developed by Akeso. It is the world’s first approved bispecific antibody that combines immuno-oncology and anti-angiogenesis mechanisms in a single molecule, helping to define a new generation of bispecific immuno-oncology therapies. Ivonescimab is also the first therapy to demonstrate positive results in a Phase III head-to-head study against pembrolizumab.
Building on its strong clinical profile in the IO2.0 landscape, Akeso is advancing a comprehensive global development program for ivonescimab across multiple tumor types and treatment settings. As a cornerstone of the Company’s IO2.0 + ADC2.0 strategy, ivonescimab aims to help reshape standards of care in major cancers worldwide.
More than 17 Phase III studies of ivonescimab are underway globally, including seven international multi-regional registrational Phase III trials and seven head-to-head studies versus PD-1/PD-L1 therapies. These programs encompass eight registrational or Phase III studies in lung cancer, as well as trials in first-line MSS/pMMR colorectal cancer, first-line PD-L1-positive head and neck squamous cell carcinoma (in combination with ligufalimab versus pembrolizumab), first-line biliary tract cancer (versus pembrolizumab/ durvalumab-based regimen), first-line triple-negative breast cancer, first-line pancreatic cancer, and first-line urothelial carcinoma (versus pembrolizumab plus a Nectin-4 ADC).
Akeso has out-licensed the exclusive rights to develop and commercialize ivonescimab in the United States and Canada, South America, Europe, the Middle East, Africa, and Japan to Summit Therapeutics under an agreement with a total potential value of up to US$5 billion.
(Press release, Akeso Biopharma, NOV 4, 2026, View Source [SID1234674217])