COMPASSION-16
Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent or metastatic cervical cancer (COMPASSION-16; sponsor study AK104-303)
Phase 3N = 445NCT04982237
- Population
- Women aged 18 to 75 years in China with previously untreated persistent, recurrent or metastatic cervical cancer; 445 eligible women enrolled between September 2021 and June 2022
- Design
- Randomised (1:1), double-blind, multicentre, placebo-controlled phase 3 trial at 59 sites in China: cadonilimab 10 mg/kg or placebo plus platinum-based chemotherapy with or without bevacizumab every 3 weeks for six cycles, then maintenance every 3 weeks for up to 2 years. Stratified by bevacizumab use and previous concurrent chemoradiotherapy. Dual primary endpoints: PFS by blinded independent central review and OS in the full analysis set.
- Primary endpoint
- PFS, OS
- Arms
- Cadonilimab plus chemotherapy (experimental): Cadonilimab 10 mg/kg every 3 weeks plus platinum-based chemotherapy with or without bevacizumab
- Placebo plus chemotherapy (control): Placebo every 3 weeks plus platinum-based chemotherapy with or without bevacizumab
- People
- Wu X, senior author Xia M
Show the numbers
| Endpoint | Analysis | Cadonilimab plus chemotherapy | Placebo plus chemotherapy | Effect |
|---|---|---|---|---|
| PFSFull analysis set | primaryWu 2024 | median 12.7 months (11.6–16.1) | median 8.1 months (7.7–9.6) | HR 0.62 (95% CI 0.49–0.80)P<0.0001PFS by blinded independent central review. |
| OSFull analysis set | primaryWu 2024 | — | median 22.8 months (17.6–29.0) | HR 0.64 (95% CI 0.48–0.86)P=0.0011The median overall survival in the cadonilimab group was not reached (95% CI 27.0 months to not estimable), so no median is entered for that arm. The abstract does not state whether this is an interim or final analysis. |
| Endpoint | Analysis | Cadonilimab plus chemotherapy | Placebo plus chemotherapy | Effect |
|---|---|---|---|---|
| PFSFull analysis set | primaryWu 2024 | median 12.7 months (11.6–16.1) | median 8.1 months (7.7–9.6) | HR 0.62 (95% CI 0.49–0.80)P<0.0001PFS by blinded independent central review. |
| OSFull analysis set | primaryWu 2024 | — | median 22.8 months (17.6–29.0) | HR 0.64 (95% CI 0.48–0.86)P=0.0011The median overall survival in the cadonilimab group was not reached (95% CI 27.0 months to not estimable), so no median is entered for that arm. The abstract does not state whether this is an interim or final analysis. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.62 | 0.49–0.8 |
| OS | 0.64 | 0.48–0.86 |
- Cadonilimab plus chemotherapy (experimental)
- Placebo plus chemotherapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Cadonilimab plus chemotherapy | Placebo plus chemotherapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 8 | 64.6% | 50.4% |
| 16 | 41.8% | 25.4% |
| 24 | 27.0% | 12.8% |
| 32 | 17.4% | 6.5% |
- Placebo plus chemotherapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Placebo plus chemotherapy |
|---|---|
| 0 | 100.0% |
| 14 | 65.3% |
| 29 | 41.4% |
| 43 | 27.1% |
| 57 | 17.7% |
Appears in
Sources
Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, et al. 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. Lancet. 2024;404(10463):1668-1676.