Akeso, Inc. announced the recent completion of the first patient enrollment in the Phase 3 randomized, double-blind, multicenter clinical trial (COMPASSION-30/AK104-309) for its independently developed PD-1/CTLA-4 bispecific antibody, cadonilimab. This study is evaluating the efficacy of cadonilimab compared to sugemalimab (PD-L1) as a consolidation therapy for patients with locally advanced, non-resectable, non-small cell lung cancer (NSCLC) who have not experienced disease progression following concurrent or sequential chemoradiotherapy.

The COMPASSION-30/AK104-309 study is led by Prof. Jinming Yu, Academician of the Chinese Academy of Engineering and Director of the Oncology Hospital at Shandong First Medical University.

Currently, consolidation therapy with immune checkpoint inhibitors following concurrent or sequential chemoradiotherapy is the standard of care for patients with unresectable NSCLC. The use of immune checkpoint inhibitors as consolidation therapy has demonstrated a modest improvement in overall survival for patients. However, despite these advancements, there continues to be a significant unmet clinical need within this patient population, underscoring the urgent demand for more effective treatment options.

As a global first-in-class bispecific antibody targeting both PD-1 and CTLA-4, cadonilimab is anticipated to enhance the efficacy of immunotherapy compared to PD-1/PD-L1 single-target antibodies. Cadonilimab exerts its effects through multiple mechanisms that contribute to the "normalization" of the tumor microenvironment. Its unique tetravalent symmetric structure, combined with Fc modifications, facilitates targeted accumulation in tumor tissues. These distinctive features enable cadonilimab to potentially improve the effectiveness of cancer immunotherapy while minimizing the risk of adverse effects.