Cadonilimab Approved in China for First-Line Treatment of Cervical Cancer—Third Indication for Akeso’s Bispecific Antibody
Thursday, June 05, 2025
Akeso, Inc. has received approval from China’s National Medical Products Administration (NMPA) for the use of its PD-1/CTLA-4 bispecific antibody, cadonilimab, as a first-line treatment for patients with persistent, recurrent, or metastatic cervical cancer. The therapy is approved for use alongside platinum-based chemotherapy, with or without bevacizumab. This marks the third approved indication for cadonilimab in China.
With this latest authorisation, cadonilimab now covers the full range of advanced cervical cancer stages, providing a new immune-based option for first-line treatment. The approval addresses a major treatment gap for cervical cancer in China, where access to effective immunotherapies remains limited. Cadonilimab is already approved for use in first-line gastric cancer and in previously treated cases of recurrent or metastatic cervical cancer.
The decision was based on results from the Phase III COMPASSION-16 (AK104-303) clinical trial, which evaluated cadonilimab in combination with chemotherapy. The study showed significant improvements in both progression-free survival and overall survival, including benefits in patients whose tumours had low or negative PD-L1 expression (CPS <1). Subgroup analysis also confirmed positive outcomes in both PD-L1-positive and PD-L1-negative groups, regardless of the use of bevacizumab.
The findings were highlighted in a late-breaking abstract at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, and subsequently published in The Lancet and reviewed in Nature Reviews Clinical Oncology.
Cervical cancer remains a leading cause of cancer-related deaths among women, particularly in advanced stages where the five-year survival rate is around 17%. In 2022, China reported 150,700 new cervical cancer cases, reflecting one of the highest burdens globally.
Cadonilimab is the first bispecific antibody targeting both PD-1 and CTLA-4 to receive regulatory approval for cervical cancer. It aims to improve immune response by combining the effects of two checkpoint inhibitors while maintaining a more favourable safety profile than using PD-1 and CTLA-4 therapies separately.
Currently, cadonilimab is featured in 16 clinical practice guidelines across several cancers, including gastric, liver, gynaecological, nasopharyngeal, and oesophageal cancers. In addition to its approved uses, it is undergoing over 30 Phase II and III trials across multiple tumour types and stages, such as lung, liver, pancreatic, and further cervical cancer indications.
This latest approval strengthens cadonilimab’s role in advancing immune-oncology approaches in China and underscores Akeso’s commitment to developing next-generation therapeutic antibodies for cancer patients worldwide.
Source: prnewswire.com
