Article Text
Abstract
Introduction Cadonilimab has been approved by China’s NMPA for advanced CC as ≥2L treatment in 2022. Here we report the benefit of adding cadonilimab to chemotherapy ± bevacizumab in 1L R/M CC.
Methods In this randomized, double-blind, placebo-controlled phase 3 trial, 1L R/M CC pts were randomized 1:1 to receive cadonilimab (10mg/kg) or placebo Q3W plus platinum-based chemotherapy ± bevacizumab (15mg/kg) per investigator discretion. Randomization were stratified by the use of bevacizumab (yes/no) and prior CCRT (yes/no). The dual primary endpoints were PFS per RECIST v1.1 assessed by BICR and OS in the ITT population.
Results 445 pts were randomized to cadonilimab group (n=222) or placebo (n=223) group. The demographic and baseline characteristics were well balanced. 59.6% of pts used bevacizumab and 48.3% received previous CCRT. 116 pts (26.1%) had a PD-L1 CPS<1. As of DCO for the PFS interim analysis (IA) (Sep 4, 2023), the median follow-up time was 17.87 mo. Median PFS was significantly improved by cadonilimab (12.7 vs 8.1 mo, HR 0.62, p<0.0001). As of the DCO for the OS IA (Apr 30, 2024), with median follow-up time of 25.63 mo, median OS was significantly prolonged by cadonilimab (NE vs 22.8 mo, HR 0.64, p=0.0011). The Benefits with cadonilimab were consistent across all predefined subgroups. Grade ≥ 3 TEAEs occurred in 85.4% of pts in cadonilimab group and 80.4% in placebo group.
Conclusion/Implications Cadonilimab significantly improved PFS and OS with manageable safety profile in patients with 1L R/M CC, which may be a new treatment option for this population.