KEYNOTE-158
Pembrolizumab for previously treated advanced anal squamous cell carcinoma: anal cancer cohort (cohort A) of the non-randomised, multicohort, phase 2 KEYNOTE-158 study
Phase 2N = 112NCT02628067
- Population
- Adults with histologically or cytologically confirmed advanced or metastatic anal squamous cell carcinoma, previous failure of or intolerance to standard therapy or no standard options, and a PD-L1-evaluable tissue sample; 163 screened, 112 enrolled and treated.
- Design
- Non-randomised, multicohort, multicentre phase 2 study (38 centres worldwide across all cohorts); this record covers the anal squamous cell carcinoma cohort (cohort A). Pembrolizumab 200 mg intravenously every 3 weeks for 2 years or until progression, unacceptable toxicity, investigator decision or withdrawal. Primary endpoint: objective response per RECIST 1.1. Efficacy and safety analyses included all patients who received at least one dose.
- Primary endpoint
- ORR
- Arms
- Pembrolizumab (experimental, n = 112): Pembrolizumab 200 mg intravenously every 3 weeks for up to 2 years
- People
- Marabelle A, senior author Delord JP
Show the numbers
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRAll treated patients, anal cancer cohort (n = 112) | primaryMarabelle 2022 | 11% (6–18%) | — | 12 patients had an objective response (6 complete and 6 partial responses per the full text). The abstract gives the median time from first dose to data cutoff as 34.7 months (IQR 32.5-36.4). |
| ORRPatients with PD-L1-positive tumours (n = 75) | primaryMarabelle 2022 | 15% (8–25%) | — | 11 of 75 patients. PD-L1 positivity was a combined positive score of 1 or higher (22C3 pharmDx assay), per the full text; the abstract does not give the cut-off. |
| ORRPatients with PD-L1-negative tumours (n = 30) | primaryMarabelle 2022 | 3% (0–17%) | — | One of 30 patients. The seven remaining patients of the 112 were six with PD-L1 'not evaluable' and one with a missing result (full text). |
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRAll treated patients, anal cancer cohort (n = 112) | primaryMarabelle 2022 | 11% (6–18%) | — | 12 patients had an objective response (6 complete and 6 partial responses per the full text). The abstract gives the median time from first dose to data cutoff as 34.7 months (IQR 32.5-36.4). |
| ORRPatients with PD-L1-positive tumours (n = 75) | primaryMarabelle 2022 | 15% (8–25%) | — | 11 of 75 patients. PD-L1 positivity was a combined positive score of 1 or higher (22C3 pharmDx assay), per the full text; the abstract does not give the cut-off. |
| ORRPatients with PD-L1-negative tumours (n = 30) | primaryMarabelle 2022 | 3% (0–17%) | — | One of 30 patients. The seven remaining patients of the 112 were six with PD-L1 'not evaluable' and one with a missing result (full text). |