Akeso has been granted its fifth Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This latest designation applies to ivonescimab in combination with chemotherapy for the first-line treatment of advanced Biliary Tract Cancer (BTC).

A randomised, controlled, multicentre, registrational phase-III clinical study (AK112-309/HARMONi-GI1) is evaluating ivonescimab plus chemotherapy versus durvalumab (a PD-L1 inhibitor) plus chemotherapy for first-line treatment of advanced BTC. Patient enrollment has been completed, and the BTD status for this indication underscores the promising clinical profile of ivonescimab. The BTD status is expected to accelerate both the ongoing clinical development and the regulatory review process in China.

Encouraging results from a phase-Ib/II study, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual meeting support the potential of the ivonescimab combination therapy as a superior first-line treatment for advanced BTC. In the study, ivonescimab plus chemotherapy achieved an Objective Response Rate (ORR) of 63.6 percent and a Disease Control Rate (DCR) of 100 percent. The ivonescimab regimen also demonstrated a median Progression-Free Survival (mPFS) of 8.5 months and a median Overall Survival (mOS) of 16.8 months.

These compelling phase-II results provide a robust foundation for the ongoing phase-III registrational trial and reinforce ivonescimab's potential to address the significant unmet needs in advanced BTC, where current treatment options often yield limited durable responses.