NMPA (China) approves cadonilimab injection for the treatment of relapsed or metastatic cervical cancer. Akeso Inc.
Akeso, Inc. a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology announced that its PD-1/CTLA-4 bi-specific antibody cadonilimab injection,( AK104) has received marketing approval from the National Medical Products Administration (NMPA) of China, for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy.
Cadonilimab is a novel, first-in-class PD-1/CTLA-4 bi-specific immuno-therapy drug in-house developed by Akeso. It is globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing .This approval not only marks China's innovative biotech companies starting to reap the fruits after years of R&D investments, but also demonstrates that Chinese biotech companies represented by Akeso are closing the gap with global pharmaceutical companies rapidly in innovative drug development.
The approval of cadonilimab by the NMPA is based on the positive results across a pivotal Phase II clinical study on cadonilimab for treatment of r/m CC patients who progressed on or after platinum-based chemotherapy. The results were presented at 2022 Society of Gynecologic Oncology(SGO) Annual Meeting.
Among 100 evaluable patients with tumor assessment, the Objective Response Rate (ORR) confirmed by Independent Radiography Review Committee (IRRC) was 33.0%, the complete response (CR) rate was 12.0% and the Duration of Response (DoR) rates at 6 and 12 months were 77.6% and 52.9% respectively. The median Progression-free Survival (PFS) was 3.75 months. The median Overall Survival (OS) was 17.51 months.
In the subgroup analysis, among the 64 patients with PD-L1 positive (CPS greater than 1), ORR was 43.8%, median PFS was 6.34 months and median OS was not reached. Among the total 111 enrolled patients, the incidence rate of Grade greater than 3 treatment related adverse events(TRAEs) was 27.0%.
China has the second largest population of cervical cancer patients in the world, with 110,000 new cases in 2020.There is no standard treatment for R/M CC patients who has progressed on or after platinum-based chemotherapy, and monotherapy is a common clinical treatment option with limited efficacy and obvious toxicity. The approval of cadonilimab addresses a huge unmet medical needs for advanced cervical cancer in China.
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