On January 3, 2022 Akeso (09926.HK) reported that Cadonilimab (PD-1/ CTLA-4 bi-specific antibody), the first-inclass novel immuno-oncology drug independently developed by the Company, combined with concurrent chemoradiotherapy obtained approval from the Center for Drug Evaluation (‘CDE’) of the National Medical Products Administration of the People’s Republic of China (”China”) to initiate a phase III clinical trial for the treatment of locally advanced cervical cancer (Press release, Akeso Biopharma, JAN 3, 2022, View Source [SID1234597986]). This is the first phase III clinical trial for locally advanced cervical cancer immunotherapy in China.
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According to the data in the Guidelines for the Diagnosis and Treatment of Cervical Cancer (2021) issued by the Gynecological Oncology Committee of the Chinese Anti-Cancer Association (中國抗癌協會婦科腫瘤專業委員會), there are about 604,000 new cases of cervical cancer and 341,000 deaths each year, both of which rank fourth in the incidence and mortality of gynecological tumors.
Relevant statistics also show that the incidence of locally advanced cervical cancer accounts for about 44.9% of those of all cervical cancers, and most of them recur within two to three years after treatment. In particular, the five-year survival rate of stage IIIA-IVA locally advanced cervical cancer is less than 60%, where currently concurrent chemoradiotherapy is considered to be the standard treatment for such patients.
Immune checkpoint inhibitors combined with radiotherapy for solid tumors have been proved to prolong patient survival, but no immune checkpoint inhibitors for locally advanced cervical cancer have been approved globally. The initiation of the phase III clinical trial of Cadonilimab combined with concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer is expected to achieve higher clinical benefits, further improving the survival of patients with locally advanced cervical cancer, and becoming a better targeted treatment option for the majority of cervical cancer patients in the near future.At the same time, the initiation of this clinical trial will further improve the indications layout of Cadonilimab in the field of cervical cancer.
Based on the positive effects of Cadonilimab obtained in the clinical trial of recurrent/ metastatic cervical cancer, CDE accepted the new drug application of Cadonilimab for the treatment of recurrent/metastatic cervical cancer in September 2021 and granted priority review designation. Cadonilimab is therefore expected to be the world’s first-in-class PD-1 based bi-specific antibody approved for market launch.
In addition, a global phase III clinical trial of Cadonilimab plus platinum-based chemotherapy combined with/without bevacizumab in the first-line treatment of persistent, recurrent or metastatic cervical cancer was initiated in May 2021. This is the first phase III clinical trial of first-line bi-specific antibody immunotherapy for cervical cancer in China.