On June 5, 2022 Akeso, Inc. (9926.HK) ( "Akeso" ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported 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) (Press release, Akeso Biopharma, JUN 5, 2022, View Source [SID1234615588]). The findings were reported in an oral presentation at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]

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.