Bibliographic Details
| Title: |
Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. |
| Authors: |
Wu, Xiaohua (AUTHOR), Sun, Yang (AUTHOR), Yang, Hongying (AUTHOR), Wang, Jing (AUTHOR), Lou, Hanmei (AUTHOR), Li, Dan (AUTHOR), Wang, Ke (AUTHOR), Zhang, Hui (AUTHOR), Wu, Tao (AUTHOR), Li, Yuzhi (AUTHOR), Wang, Chunyan (AUTHOR), Li, Guiling (AUTHOR), Wang, Yifeng (AUTHOR), Li, Dapeng (AUTHOR), Tang, Ying (AUTHOR), Pan, Mei (AUTHOR), Cai, Hongyi (AUTHOR), Wang, Weihu (AUTHOR), Yang, Bing (AUTHOR), Qian, Hua (AUTHOR) |
| Source: |
Lancet. 10/26/2024, Vol. 404 Issue 10463, p1668-1676. 9p. |
| Subjects: |
Leukocyte count, Clinical trials, Bispecific antibodies, Overall survival, Progression-free survival |
| Abstract: |
Cadonilimab is a bispecific antibody targeting PD-1 and CTLA-4, which has shown substantial clinical benefits in advanced cervical cancer. In the COMPASSION-16 trial, we aimed to evaluate the addition of cadonilimab to first-line standard chemotherapy in persistent, recurrent, or metastatic cervical cancer. In this randomised, double-blind, multicentre, placebo-controlled phase 3 trial, women aged 18–75 years across 59 clinical sites in China with previously untreated persistent, recurrent, or metastatic cervical cancer were randomly assigned (1:1) to receive cadonilimab (10 mg/kg) or placebo plus platinum-based chemotherapy with or without bevacizumab every 3 weeks for six cycles, followed by maintenance therapy every 3 weeks for up to 2 years. Randomisation was performed centrally through an interactive web-response system. Stratification factors were the use of bevacizumab (yes or no) and previous concurrent chemoradiotherapy (yes or no). The dual primary outcomes were progression-free survival as assessed by blinded independent central review and overall survival in the full analysis set. This study is registered with ClinicalTrials.gov , NCT04982237 ; the study has completed enrolment and is ongoing for treatment and follow-up. 445 eligible women were enrolled between Sept 11, 2021, and June 23, 2022. Median progression-free survival was 12·7 months (95% CI 11·6–16·1) in the cadonilimab group and 8·1 months (7·7–9·6) in the placebo group (hazard ratio 0·62 [95% CI 0·49–0·80], p<0·0001); median overall survival was not reached (27·0 months to not estimable) versus 22·8 months (17·6–29·0), respectively (hazard ratio 0·64 [0·48–0·86], p=0·0011). The most common grade 3 or higher adverse events were decreased neutrophil count, decreased white blood cell count, and anaemia. The addition of cadonilimab to first-line standard chemotherapy significantly improved progression-free survival and overall survival with a manageable safety profile in participants with persistent, recurrent, or metastatic cervical cancer. The data support the use of cadonilimab plus chemotherapy as an efficacious first-line therapy in persistent, recurrent, or metastatic cervical cancer. Akeso Biopharma. [ABSTRACT FROM AUTHOR] |
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| Database: |
Psychology and Behavioral Sciences Collection |
