KEYNOTE-158
Pembrolizumab in previously treated advanced cervical cancer: cervical cohort of the phase 2 KEYNOTE-158 basket study
Phase 2N = 98NCT02628067
- Population
- Previously treated advanced cervical cancer; 98 patients treated, 82 (83.7%) with PD-L1-positive tumours (combined positive score 1 or more)
- Design
- Phase 2 multi-cohort (basket) study of advanced solid tumours; this record covers the cervical cancer cohort. Pembrolizumab 200 mg every 3 weeks for 2 years or until progression, intolerable toxicity, or physician or patient decision. Primary endpoint: objective response rate per RECIST v1.1 by independent central radiologic review. Interim results.
- Primary endpoint
- ORR
- Arms
- Pembrolizumab (experimental, n = 98): Pembrolizumab 200 mg every 3 weeks for up to 2 years
- People
- Chung HC, senior author Leary A
Show the numbers
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRTreated patients, cervical cohort (n = 98)Objective response rate per RECIST v1.1 by independent central radiologic review | interimmedian follow-up 10.2 monthsChung 2019 | 12.2% (6.5–20.4%) | — | Three complete and nine partial responses. Median duration of response was not reached (range 3.7 or more to 18.6 or more months). Median follow-up 10.2 months (range 0.6 to 22.7). |
| ORRPD-L1-positive (CPS 1 or more) patients with one or more prior lines of chemotherapy for recurrent or metastatic disease (n = 77) | interimChung 2019 | 14.3% (7.4–24.1%) | — | The abstract words this as '14.3% of these responses were in those who had received one or more lines of chemotherapy', which is garbled. The figure equals 11 of 77 patients and matches the current FDA prescribing information (openFDA Keytruda label, section 14.12, read 20 Oct 2026): of the 98 patients, 77 had CPS 1 or more and at least one chemotherapy line in the metastatic setting, ORR 14.3% (95% CI 7.4-24.1), 11 responders. It is therefore recorded as the response rate in those 77 patients. |
| ORRPD-L1-positive (CPS 1 or more) patients (n = 82) | interimChung 2019 | 14.6% (7.8–24.2%) | — | All 12 responses occurred in patients with PD-L1-positive tumours. The abstract does not give the number or response rate for PD-L1-negative patients. |
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRTreated patients, cervical cohort (n = 98)Objective response rate per RECIST v1.1 by independent central radiologic review | interimmedian follow-up 10.2 monthsChung 2019 | 12.2% (6.5–20.4%) | — | Three complete and nine partial responses. Median duration of response was not reached (range 3.7 or more to 18.6 or more months). Median follow-up 10.2 months (range 0.6 to 22.7). |
| ORRPD-L1-positive (CPS 1 or more) patients with one or more prior lines of chemotherapy for recurrent or metastatic disease (n = 77) | interimChung 2019 | 14.3% (7.4–24.1%) | — | The abstract words this as '14.3% of these responses were in those who had received one or more lines of chemotherapy', which is garbled. The figure equals 11 of 77 patients and matches the current FDA prescribing information (openFDA Keytruda label, section 14.12, read 20 Oct 2026): of the 98 patients, 77 had CPS 1 or more and at least one chemotherapy line in the metastatic setting, ORR 14.3% (95% CI 7.4-24.1), 11 responders. It is therefore recorded as the response rate in those 77 patients. |
| ORRPD-L1-positive (CPS 1 or more) patients (n = 82) | interimChung 2019 | 14.6% (7.8–24.2%) | — | All 12 responses occurred in patients with PD-L1-positive tumours. The abstract does not give the number or response rate for PD-L1-negative patients. |