EMPOWER-Cervical 1
Cemiplimab versus investigator's choice single-agent chemotherapy in recurrent cervical cancer after first-line platinum-containing chemotherapy (EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9)
Phase 3N = 608NCT03257267
- Population
- Recurrent cervical cancer with disease progression after first-line platinum-containing chemotherapy, regardless of PD-L1 status; squamous-cell carcinoma and adenocarcinoma (including adenosquamous carcinoma)
- Design
- Open-label, randomised (1:1) phase 3 trial of cemiplimab 350 mg every 3 weeks versus investigator's choice of single-agent chemotherapy, regardless of PD-L1 status. Primary endpoint: overall survival; progression-free survival and safety also assessed.
- Primary endpoint
- OS
- Arms
- Cemiplimab (experimental, n = 304): Cemiplimab 350 mg every 3 weeks
- Investigator's choice chemotherapy (control, n = 304): Single-agent chemotherapy chosen by the investigator
- People
- Tewari KS, senior author Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9, Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9
OSHR 0.69 (95% CI 0.56–0.84)Δ median OS+3.5 monthsPFSHR 0.75 (95% CI 0.63–0.89)Δ ORR+10.1 points
Show the numbers
| Endpoint | Analysis | Cemiplimab | Investigator's choice chemotherapy | Effect |
|---|---|---|---|---|
| OSOverall trial population (N = 608) | primaryTewari 2022 | median 12 months | median 8.5 months | HR 0.69 (95% CI 0.56–0.84)P<0.001The abstract states the survival benefit was consistent in both histologic subgroups (squamous-cell carcinoma, and adenocarcinoma including adenosquamous carcinoma) without giving numbers. |
| PFSOverall trial population (N = 608) | primaryTewari 2022 | — | — | HR 0.75 (95% CI 0.63–0.89)P<0.001The abstract gives no median PFS. |
| ORROverall trial population (N = 608) | primaryTewari 2022 | 16.4% (12.5–21.1%) | 6.3% (3.8–9.6%) | — |
| ORRCemiplimab group, PD-L1 expression 1% or more | primaryTewari 2022 | 18% (11–28%) | — | Subgroup of the cemiplimab arm; the abstract gives no comparator figure. |
| ORRCemiplimab group, PD-L1 expression below 1% | primaryTewari 2022 | 11% (4–25%) | — | Subgroup of the cemiplimab arm; the abstract gives no comparator figure. |
| Endpoint | Analysis | Cemiplimab | Investigator's choice chemotherapy | Effect |
|---|---|---|---|---|
| OSOverall trial population (N = 608) | primaryTewari 2022 | median 12 months | median 8.5 months | HR 0.69 (95% CI 0.56–0.84)P<0.001The abstract states the survival benefit was consistent in both histologic subgroups (squamous-cell carcinoma, and adenocarcinoma including adenosquamous carcinoma) without giving numbers. |
| PFSOverall trial population (N = 608) | primaryTewari 2022 | — | — | HR 0.75 (95% CI 0.63–0.89)P<0.001The abstract gives no median PFS. |
| ORROverall trial population (N = 608) | primaryTewari 2022 | 16.4% (12.5–21.1%) | 6.3% (3.8–9.6%) | — |
| ORRCemiplimab group, PD-L1 expression 1% or more | primaryTewari 2022 | 18% (11–28%) | — | Subgroup of the cemiplimab arm; the abstract gives no comparator figure. |
| ORRCemiplimab group, PD-L1 expression below 1% | primaryTewari 2022 | 11% (4–25%) | — | Subgroup of the cemiplimab arm; the abstract gives no comparator figure. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.69 | 0.56–0.84 |
| PFS | 0.75 | 0.63–0.89 |
- Cemiplimab (experimental)
- Investigator's choice chemotherapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Cemiplimab | Investigator's choice chemotherapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 8 | 63.0% | 52.1% |
| 15 | 42.0% | 29.4% |
| 23 | 26.5% | 15.3% |
| 30 | 17.7% | 8.7% |