Supplementary Table S2 from Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study

Lou, Hanmei; Cai, Hongbing; Huang, Xin; Li, Guiling; Wang, Li; Liu, Fei; Qin, Wenjing; Liu, Ting; Liu, Wei; Wang, Zhongmin Maxwell; Li, Baiyong; Xia, Yu; Wang, Jing

doi:10.1158/1078-0432.25603675.v1

Supplementary Table S2 from Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study

journal contribution

posted on 2024-04-15, 07:23 authored by Hanmei Lou, Hongbing Cai, Xin Huang, Guiling Li, Li Wang, Fei Liu, Wenjing Qin, Ting Liu, Wei Liu, Zhongmin Maxwell Wang, Baiyong Li, Yu Xia, Jing Wang

Supplementary Table S2. The summary of confirmed best overall response.

History

ARTICLE ABSTRACT

Immune checkpoint inhibitors (ICI) have been a potential treatment option for patients with cervical cancer in several clinical studies. We investigated the safety and efficacy of cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, plus standard therapy for the first-line treatment of R/M CC (recurrent and/or metastatic cervical cancer). Eligible patients were assigned to 3 cohorts: cohort A-15 (cadonilimab 15 mg/kg every 3 weeks (Q3W) plus chemotherapy), cohort A-10 (cadonilimb 10 mg/kg Q3W plus chemotherapy), and cohort B-10 (cadonilimab 10 mg/kg Q3W plus chemotherapy and bevacizumab). They received the corresponding treatments until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. The primary objective was safety; the secondary endpoints included objective overall response (ORR), duration of response, disease control rate, progression-free survival, and overall survival. This study is registered with ClinicalTrials.gov (NCT04868708). As of February 13, 2023, treatment-related adverse events (TRAE) occurred in 45 (100.0%) patients. Grade ≥3 TRAEs were reported in 33 (73.3%) patients. Immune-related adverse events (irAE) occurred in 29 (64.4%) patients and grade ≥3 irAEs were observed in 9 (20.0%) patients. Seven (15.6%) of 45 patients permanently discontinued cadonilimab treatment due to TRAEs. One death due to hemorrhagic shock occurred in cohort B-10. Among 44 patients who underwent at least one post-baseline tumor assessment, the ORR was 66.7% in cohort A-15, 68.8% in cohort A-10, 92.3% in cohort B-10, and 79.3% in cohorts A-10 and B-10 combined. Cadonilimab combined with standard therapy was acceptable, with encouraging antitumor activity in patients with R/M CC.