Akeso Biopharma shared on LinkedIn:
“We are proud to share the positive Phase III HARMONiGI1 results for ivonescimab plus chemotherapy in first-line advanced biliarytractcancer (BTC), presented today at the ESMO2026 Presidential Symposium.
In a head-to-head comparison against the current standard of care (durvalumab + chemotherapy), ivonescimab delivered statistically significant and clinically meaningful improvements:
- OS: 14.9 vs 12.1 months (HR=0.75; 25% reduction in risk of death)
- PFS: 8.4 vs 5.8 months (HR=0.61; 39% reduction in risk of disease progression or death)
- ORR: 53.8% vs 32.5%
The safety profile remained manageable with no new safety signals.
Congratulations to the investigators, and to our dedicated teams. This is a powerful validation of our IO2.0+ strategy and the dual PD-1/VEGF mechanism, and another major clinical proof point beyond lung cancer.
A huge thank you to the patients and their families who made this study possible.”
At the ESMO Congress 2026, Jian Zhou (Shanghai, China) presented results from the Phase III HARMONi-GI1 trial (NCT06591520), evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for patients with unresectable locally advanced or metastatic biliary tract cancer (BTC).
The preplanned interim analysis, presented during Presidential Symposium II as Late-Breaking Abstract LBA8, assessed overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety.
Learn more: HARMONi-GI1 at ESMO 2026: Ivonescimab Plus Chemotherapy in Advanced Biliary Tract Cancer
