Akeso announces oral presentation featuring promising clinical data of Cadonilimab (PD-1/CTLA-4 BsAbs, AK104) for the first-line treatment of R/M cervical cancer at ASCO 2022

HONG KONG,June 6,2022 -- 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,Akesois conducting a phase III study of Cadonilimab plus platinum-based chemotherapy +/- bevacizumab in first-line treatment for R/M cervical cancer. In September 2021,Akesosubmitted NDA in China for Cadonilimabfor 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]

Reference

[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.

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