Akeso Inc., a biotechnology company, has announced the approval to initiate a global, multicenter, randomized Phase II registrational trial for their PD-1/CTLA-4 bispecific antibody, cadonilimab. The trial, known as COMPASSION-36/AK104-225, has received regulatory clearance from both China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). This trial will evaluate the efficacy of cadonilimab in combination with lenvatinib versus lenvatinib alone in treating advanced hepatocellular carcinoma $(HCC)$ in patients who have previously been treated with atezolizumab and bevacizumab. This approval marks a significant step for Akeso in addressing the global challenge of cancer immunotherapy resistance and advancing treatment options for patients with limited survival benefits from current therapies.
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