China’s National Medical Products Administration (NMPA) has approved Akeso’s PD-1/CTLA-4 bispecific antibody, cadonilimab, to treat persistent, recurrent or metastatic cervical cancer.
This third indication approval allows its use in combination with platinum-based chemotherapy and potentially bevacizumab.
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The therapy is also approved for treating advanced gastric cancer and relapsed or metastatic cervical cancer after platinum-based chemotherapy failure.
The NMPA approval is based on the results from the Phase III COMPASSION-16 study. Patients treated with cadonilimab in this trial exhibited efficacy benefits, particularly those whose tumours tested negative for PD-L1 expression, when compared to the control group.
The study achieved both overall survival (OS) and progression-free survival (PFS) endpoints.
Further insights from COMPASSION-16 revealed that irrespective of PD-L1 status or bevacizumab use, patient subgroups experienced enhanced outcomes with cadonilimab therapy.
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By GlobalDataThe inclusion of this new agent in 16 clinical guidelines features its growing importance across oncology fields such as gastric and gynaecological cancers.
Akeso founder, chairwoman, president and CEO Xia Yu commented: “Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings.
“This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and patient quality of life.
“This achievement reflects Akeso’s robust innovation capabilities and commitment to cancer patient outcomes, and aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide.”
More than 30 ongoing Phase II and III trials are evaluating cadonilimab’s potential against other malignancies, including lung and pancreatic cancers.
