Cadonilimab combined with chemotherapy with or without bevacizumab as first-line treatment in recurrent or metastatic cervical cancer (COMPASSION-13): a phase 2 study

Abstract Purpose: Immune checkpoint inhibitors (ICIs) have been 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. Patients and Methods: Eligible patients were assigned to 3 cohorts: cohort A-15 (cadonilimab 15mg/kg every 3 weeks (Q3W) plus chemotherapy), cohort A-10 (cadonilimb 10mg/kg Q3W plus chemotherapy), and cohort B-10 (cadonilimab 10mg/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 (DoR), disease control rate (DCR), progression free survival (PFS), and overall survival (OS). This study is registered with ClinicalTrials.gov (NCT04868708). Results: As of Feburary 13, 2023, treatment-related adverse events (TRAEs) occurred in 45 (100·0%) patients. Grade ≥3 TRAEs were reported in 33 (73·3%) patients. Immune-related adverse events (irAEs) occurred in 29 (64·4%) patients and grade ≥3 irAEs were observed in 9 (20·0%) patients. 7 (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 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 cohortA-10 and cohort B-10 combined. Conclusions: Cadonilimab combined with standard therapy was acceptable, with encouraging antitumor activity in patients with R/M CC.