Cadonilimab regimen extends survival in advanced cervical cancer
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Key takeaways:
- The addition of cadonilimab to chemotherapy extended PFS and OS.
- The most common grade 3 or higher adverse events with cadonilimab included decreased neutrophil and white blood cell counts.
The addition of cadonilimab to first-line chemotherapy improved outcomes among certain women with cervical cancer.
Researchers observed improved PFS and OS with the combination.
Cadonilimab (Akeso Biopharma) is a bispecific antibody that targets PD-1 and CTLA-4.
In the randomized phase 3 COMPASSION-16 trial, researchers evaluated the addition of cadonilimab to standard first-line chemotherapy for women with persistent, recurrent or metastatic cervical cancer.
The study included 445 adults across 59 clinical sites in China. All women had persistent, recurrent or metastatic cervical cancer but had not received treatment.
Researchers randomly assigned women 1:1 to 10 mg/kg cadonilimab (n = 222) or placebo (n = 223) plus platinum-based chemotherapy with or without bevacizumab (Avastin, Genentech) every 3 weeks for six cycles. Women then received maintenance therapy every 3 weeks for up to 2 years.
PFS and OS served as dual primary outcomes.
Results showed longer median PFS (12.7 months vs. 8.1 months; HR = 0.62; 95% CI, 0.49-0.8) and OS (not reached vs. 22.8 months; HR = 0.64; 95% CI, 0.48-0.86) in the cadonilimab group.
The PFS benefit with cadonilimab appeared stronger among women who did not receive bevacizumab (HR = 0.46; 95% CI, 0.32-0.66) than those who did (HR = 0.81; 95% CI, 0.58-1.13).
The OS benefit with cadonilimab also appeared stronger among women who did not receive bevacizumab (median, 28.2 months vs. 15.1 months; HR = 0.5; 95% CI, 0.33-0.75) than those who did (median not reached in either group; HR = 0.84; 95% CI, 0.56-1.26).
Nearly all women in the cadonilimab and placebo groups experienced treatment-related adverse events (> 99% vs. 100%), with a majority experiencing grade 3 or higher treatment-related adverse events (82% vs. 79%). A higher percentage of women assigned cadonilimab experienced immune-related adverse events (any grade, 46% vs. 7%; grade 3 or higher, 10% vs. < 1%).
Adverse events prompted a higher percentage of women in the cadonilimab group to discontinue any treatment agent (28% vs. 11%). A higher percentage of women assigned cadonilimab died due to adverse events (5% vs. 3%).
“We speculate that the efficacy shown in the subgroup without bevacizumab use could be attributable to the combined anti-PD-1 and anti-CTLA-4 activity of cadonilimab,” Xiaohua Wu, MD, PhD, supervisor of oncology at Fudan University Cancer Institute, and colleagues wrote. “Cadonilimab might offer a more suitable treatment option for individuals who are not eligible for bevacizumab therapy.”
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Wu X, et al. Lancet. 2024;doi:10.1016/S0140-6736(24)02135-4.
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