Akeso Inc. has announced that its bispecific antibody ivonescimab has received its fifth Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) of China for use in combination with chemotherapy as a first-line treatment for advanced biliary tract cancer $(BTC)$. This designation follows previous recognitions for indications in lung cancer and triple-negative breast cancer. A randomized, controlled, multicenter Phase III clinical study (AK112-309/HARMONi-GI1) is currently underway, comparing ivonescimab plus chemotherapy to durvalumab plus chemotherapy for first-line treatment of advanced BTC. Patient enrollment for this trial has been completed. Results from a Phase 1b/II study were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, showing an objective response rate of 63.6% and a disease control rate of 100% for ivonescimab plus chemotherapy. The regimen also demonstrated a median progression-free survival of 8.5 months and a median overall survival of 16.8 months. These results provide the basis for the ongoing Phase III trial and further clinical development of ivonescimab in advanced BTC.

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