Cadonilimab Approved for First-Line Cervical Cancer Treatment in All-Comers

HONG KONG, June 4, 2025 – Akeso, Inc. has announced a significant development in cancer treatment, with the National Medical Products Administration (NMPA) approving its novel PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer. This approval allows the use of cadonilimab in combination with platinum-based chemotherapy, with or without the addition of bevacizumab. This marks the third clinical indication for cadonilimab, signifying its broad applicability in advanced cancer care.

The authorization for cadonilimab's use targets a critical need for new immune-based therapies for cervical cancer patients in China. It provides an innovative approach to treating advanced cervical cancer across all stages, enhancing therapeutic options for patients facing this challenging disease. Apart from cervical cancer, cadonilimab is approved for first-line treatment of advanced gastric cancer and for cases of relapsed or metastatic cervical cancer that have progressed despite previous platinum-based chemotherapy treatments.

The approval was based on encouraging results from the COMPASSION-16 (AK104-303) Phase III clinical study, which demonstrated the efficacy of cadonilimab combined with chemotherapy in first-line cervical cancer treatment. Notably, the study highlighted a significant improvement in progression-free survival (PFS) and overall survival (OS) among patients, including a subgroup with PD-L1 negative tumors, showing a higher percentage in the treatment group compared to controls. The findings from COMPASSION-16 suggest that cadonilimab can benefit patients regardless of PD-L1 status, whether or not bevacizumab is used alongside chemotherapy.

The importance of these results was underscored by their presentation at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting as a Late-Breaking Abstract, with subsequent publication in prestigious journals such as The Lancet and Nature Reviews Clinical Oncology. These publications reflect the international recognition of the study's contributions to cervical cancer research.

Cervical cancer remains a major health concern worldwide, particularly affecting women, with a daunting 5-year survival rate of just 17% for those with advanced-stage disease. In 2022, China reported 150,700 new cases, indicating the country's substantial burden in managing cervical cancer.

Professor Wu Xiaohua, the principal investigator of the COMPASSION-16 study and a faculty member at Fudan University Shanghai Cancer Center, emphasized cadonilimab's groundbreaking efficacy and low toxicity in treating recurrent and metastatic cervical cancer. He noted that cadonilimab's strong anti-tumor activity is evident regardless of PD-L1 expression, setting new standards in cancer treatment. This is expected to expedite the clinical utilization of cadonilimab, ultimately benefiting a larger patient population.

Dr. Xia Yu, founder and CEO of Akeso, highlighted the significant survival benefits provided by cadonilimab across various patient groups, both in clinical trials and real-world settings. She stated that cadonilimab offers enhanced therapeutic outcomes over PD-1/PD-L1 monotherapies, with notable benefits for patients with low PD-L1 expression or resistance to PD-1 treatments. The synergistic effect of targeting both PD-1 and CTLA-4 results in fewer immune-related side effects compared to conventional antibody therapies. This approval underscores the progress in immunotherapy 2.0 for cervical cancer, improving patient care and quality of life. The achievement reflects Akeso's commitment to innovation and aligns with their vision to lead in developing next-generation therapeutic antibodies on a global scale.

Cadonilimab is currently referenced in 16 key clinical treatment guidelines and consensus documents across multiple cancer types, including gastric, liver, esophageal, and nasopharyngeal cancers. Beyond its approved uses, cadonilimab is being evaluated in over 30 Phase II and III trials for various cancers, encompassing different stages and sub-types, such as lung, liver, and pancreatic cancers.