HONG KONG, China I June 5, 2022 I Akeso, Inc. (9926.HK) ( “Akeso” ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, released updated results of Cadonilimab (PD-1/CTLA-4 Bispecific, AK104) combined with platinum-based chemotherapy +/- bevacizumab for the first-line treatment of recurrent/metastatic cervical cancer (R/M CC). The findings were reported in an oral presentation at 2022 ASCO Annual Meeting.

Summary of the clinical results:

  • At dose of 10mg/kg, regardless of CPS status, Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab, the objective response rate (ORR) was 79.3%; in CPS≥1 and CPS<1 population, ORR was 82.4% and 75.0%, respectively. Progression-free survival (PFS) or overall survival (OS) data is not mature by the cut-off date.
  • Among all evaluable patients treated with the 10 mg/kg dose, 41.4% of the patients were PD-L1-negative patients (CPS<1)
  • The incidence of ≥3 grade TRAE of the trial was 60.0%.

As of April 18, 2022, the study evaluated the safety of all patients and the efficacy of patients who received at least one tumor evaluation. The results of Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab continued the excellent performance of Cadonilimab monotherapy for second-or third-line R/M CC and demonstrating a promising therapeutic solution for all patients with advanced cervical cancer.

Based on the excellent efficacy and safety results of phase II study, Akeso is conducting a phase III study of Cadonilimab plus platinum-based chemotherapy +/- bevacizumab in first-line treatment for R/M cervical cancer. In September 2021, Akeso submitted NDA in China for Cadonilimab for the treatment of second-or third-line R/M CC under priority review. In addition, a phase III study of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is also ongoing.

Related Study

FDA has approved Pembrolizumab plus chemotherapy +/- bevacizumab for first-line treatment of persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test (KEYNOTE-826 study). According to the KEYNOTE-826 study, in the Pembrolizumab arm, ORR was 65.9% in the all-comer population and 68.1% in the CPS≥1 population, the percentage of patients with CPS <1 was 11.4%, the incidence of ≥3 grade TRAE was 68.4%. In the placebo arm (placebo plus chemotherapy +/- bevacizumab), ORR was 50.2% in the CPS≥1 population.[1][2]


[1] Colombo N, Dubot C, Lorusso D, et al; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435.

[2] Disclaimer: the study mentioned above is for reference only. It doesn’t necessarily represent the latest clinical study ongoing for the same indication, and it is not a head-to-head study derived from Cadonilimab clinical trial.