KEYNOTE-158
Pembrolizumab in previously treated advanced noncolorectal MSI-H/dMMR cancer (KEYNOTE-158)
Phase 2N = 233NCT02628067
- Population
- Previously treated advanced noncolorectal MSI-H/dMMR cancer; 27 tumour types (endometrial, gastric, cholangiocarcinoma and pancreatic the most common)
- Design
- Phase 2 study of pembrolizumab 200 mg every 3 weeks for up to 2 years in previously treated advanced noncolorectal MSI-H/dMMR cancer; primary end point objective response rate (RECIST 1.1) by independent central review. Single-arm, multi-tumour cohort; the abstract does not give results by tumour type.
- Primary endpoint
- ORR
- Arms
- Pembrolizumab (experimental, n = 233): Pembrolizumab 200 mg every 3 weeks for 2 years or until progression, toxicity or withdrawal
- People
- Marabelle A
Show the numbers
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRAll enrolled noncolorectal MSI-H/dMMR patients (233); not specific to pancreatic cancer | primarymedian follow-up 13.4 monthsMarabelle 2020 | 34.3% (28.3–40.8%) | — | — |
| PFSAll enrolled noncolorectal MSI-H/dMMR patients (233); not specific to pancreatic cancer | primaryMarabelle 2020 | median 4.1 months (2.4–4.9) | — | — |
| OSAll enrolled noncolorectal MSI-H/dMMR patients (233); not specific to pancreatic cancer | primaryMarabelle 2020 | median 23.5 months | — | The 95% CI is 13.5 months to not reached; an open upper bound cannot be shown here. |
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRAll enrolled noncolorectal MSI-H/dMMR patients (233); not specific to pancreatic cancer | primarymedian follow-up 13.4 monthsMarabelle 2020 | 34.3% (28.3–40.8%) | — | — |
| PFSAll enrolled noncolorectal MSI-H/dMMR patients (233); not specific to pancreatic cancer | primaryMarabelle 2020 | median 4.1 months (2.4–4.9) | — | — |
| OSAll enrolled noncolorectal MSI-H/dMMR patients (233); not specific to pancreatic cancer | primaryMarabelle 2020 | median 23.5 months | — | The 95% CI is 13.5 months to not reached; an open upper bound cannot be shown here. |
- Pembrolizumab (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Pembrolizumab |
|---|---|
| 0 | 100.0% |
| 3 | 60.2% |
| 5 | 42.9% |
| 8 | 25.9% |
| 10 | 18.4% |
- Pembrolizumab (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Pembrolizumab |
|---|---|
| 0 | 100.0% |
| 15 | 64.2% |
| 29 | 42.5% |
| 44 | 27.3% |
| 59 | 17.5% |