Akeso's Ivonescimab: A Potential Game-Changer for Biliary Tract Tumors

Akeso Biopharma (9926.HK) has announced the enrollment of the first patient in its Phase 3 trial, AK112-309, evaluating the efficacy of Ivonescimab in combination with chemotherapy as a first-line therapy for advanced biliary tract cancers (BTC) compared to durvalumab. This marks a significant step in the development of a potential new standard of care for these challenging malignancies.

Biliary tract cancers are highly heterogeneous and associated with a poor prognosis, with approximately 50% of patients already in advanced stages at diagnosis. Although PD-1/L1 inhibitors in combination with chemotherapy have been approved as a first-line treatment, the overall survival benefit has been limited, particularly for patients with gallbladder cancer. Akeso's Ivonescimab, a PD-1/VEGF bispecific antibody, offers hope for improved outcomes in this underserved patient population.

Ivonescimab has already demonstrated promising results in a Phase II clinical study. The regimen exhibited significant antitumor activity and a good safety profile in BTC, with an objective response rate (ORR) of 63.6% and a disease control rate (DCR) of 100%. The median progression-free survival (PFS) was 8.5 months, with a 6-month PFS rate of 84.4%. Furthermore, the median overall survival (OS) was 16.8 months, with a 9-month OS rate of 81.8%. Notably, patients with gallbladder cancer showed a median OS of 16.8 months.


The AK112-309 trial aims to evaluate the efficacy of Ivonescimab combined with chemotherapy versus durvalumab plus chemotherapy in advanced biliary tract cancers. The primary endpoint is overall survival (OS), with progression-free survival (PFS) and objective response rate (ORR) as secondary endpoints. If successful, Ivonescimab could become a new standard of care for first-line treatment of biliary tract tumors, potentially improving survival outcomes and quality of life for patients.


Akeso's success in this trial could have significant market implications and competitive advantages. If Ivonescimab demonstrates superior efficacy and safety compared to durvalumab, it could significantly impact the market for first-line therapies in biliary tract tumors. This could lead to increased market share for Akeso, potentially displacing durvalumab as the standard of care. The combination's potential benefits, such as improved overall survival and progression-free survival, could attract more patients and healthcare providers, further boosting Akeso's market position.

In conclusion, Akeso's Ivonescimab offers a promising approach to the treatment of biliary tract tumors. The enrollment of the first patient in the Phase 3 trial signals a potential shift in the standard of care for these challenging malignancies. If the trial results confirm the significant antitumor activity and good safety profile demonstrated in the Phase 2 study, Ivonescimab could become a new standard of care for first-line treatment of biliary tract tumors, potentially improving survival outcomes and quality of life. Investors should closely monitor the progress of this trial and consider the potential market implications and competitive advantages of a successful outcome.