Cadonilimab plus platinum-based chemotherapy ± bevacizumab for persistent, recurrent, or metastatic cervical cancer: Subgroup analyses of COMPASSION-16.

5509 Background: The phase 3 COMPASSION-16 trial demonstrated statistically significant progression-free survival (PFS) and overall survival (OS) benefits with cadonilimab plus chemotherapy ± bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer (R/M CC). This analysis assessed efficacy in several key clinical subgroups. Methods: R/M CC pts who had no prior systemic treatment were randomized 1:1 to receive cadonilimab (10 mg/kg) or placebo Q3W plus platinum-based chemotherapy ± bevacizumab (15 mg/kg). The dual primary endpoints were PFS per RECIST v1.1 assessed by blind independent central review and OS in the ITT population. Treatment effects on PFS and OS were evaluated in subgroups including age (<65 or ≥65 years), bevacizumab use (yes or no), prior concurrent chemoradiotherapy (CCRT; yes or no), metastatic disease at baseline (yes or no), PD-L1 CPS (<1, ≥1, or ≥10), and platinum use (cisplatin or carboplatin). Hazard ratios (HRs) and 95% CIs were estimated from an unstratified Cox model. Results: 445 patients were randomized (222 to the cadonilimab group and 223 to the placebo group). At the Apr 30, 2024 data cutoff, the median follow-up was 26 months. The addition of cadonilimab prolonged PFS and OS in all investigated subgroups (Table). Conclusions: Subgroup analyses of COMPASSION-16 showed that the addition of cadonilimab to chemotherapy ± bevacizumab improved PFS and OS across subgroups defined by age, bevacizumab use, prior CCRT, metastatic disease, PD-L1 CPS, and platinum use, consistent with results for the overall population. Cadonilimab plus standard treatment is a potential treatment option for patients with R/M CC. Clinical trial information: NCT04982237 . Subgroup (N) Median PFS (mo)Cadonilimab Median PFS (mo)Placebo PFS, HR (95% CI) Median OS (mo)Cadonilimab Median OS (mo)Placebo OS, HR (95% CI) <65 yrs (369) 13.5 9.5 0.68 (0.52, 0.88) NR 25.3 0.69 (0.50, 0.95) ≥65 yrs (74) 12.0 7.4 0.39 (0.22, 0.68) 26.6 15.5 0.49 (0.27, 0.91) With bevacizumab (265) 15.1 11.5 0.78 (0.57, 1.06) NR NR 0.84 (0.56, 1.26) Without bevacizumab (180) 11.7 6.7 0.44 (0.31, 0.63) 28.8 15.1 0.50 (0.33, 0.75) CCRT, yes (215) 16.1 7.9 0.55 (0.39, 0.78) NR 22.8 0.54 (0.35, 0.82) CCRT, no (230) 12.0 8.5 0.67 (0.49, 0.93) 27.0 24.5 0.76 (0.52, 1.12) Metastatic, yes (323) 12.0 8.3 0.70 (0.54, 0.92) 28.8 25.3 0.73 (0.52, 1.02) Metastatic, no (122) NR 8.0 0.42 (0.25, 0.70) NR 17.6 0.48 (0.27, 0.86) PD-L1 CPS<1 (116) 12.0 8.2 0.65 (0.42, 1.03) NR 25.3 0.77 (0.44, 1.34) PD-L1 CPS≥1 (312) 14.7 8.3 0.62 (0.47, 0.83) NR 22.7 0.69 (0.49, 0.97) PD-L1 CPS≥10 (180) 17.1 8.1 0.54 (0.37, 0.79) NR