Akeso Announces Approval to Initiate Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma

Core Viewpoint - Akeso, Inc. has received approval to initiate a global Phase II trial for cadonilimab, a bispecific antibody, to treat advanced hepatocellular carcinoma (HCC) in patients previously treated with other therapies, addressing a significant unmet need in cancer treatment [1][4][6] Group 1: Clinical Development - The COMPASSION-36/AK104-225 trial is a pivotal part of cadonilimab's global development strategy, aiming to improve treatment options for patients with HCC who have developed resistance to existing therapies [2][3] - Cadonilimab is the first bispecific antibody approved globally for cancer immunotherapy, demonstrating potential in combination therapies for HCC and other malignancies [5][6] Group 2: Market Need - HCC is a prevalent cancer, with approximately 865,000 new cases reported globally in 2022, and there are currently no FDA-approved second-line therapies for patients whose disease progresses after first-line treatment [4][6] - The lack of effective second-line treatment options for advanced malignancies highlights the critical need for new therapeutic strategies, which cadonilimab aims to address [3][4] Group 3: Research and Innovation - Akeso is advancing multiple clinical trials for cadonilimab, including studies for neoadjuvant therapy and combination therapies with other agents, showcasing its commitment to addressing cancer immunotherapy resistance [6][10] - The company has a robust pipeline of over 50 innovative assets, with 24 candidates in clinical trials, reflecting its focus on developing first-in-class and best-in-class therapies [10]