KEYNOTE-164

NCT02460198 📎

Regimen

Experimental
Pembrolizumab 200 mg Q3W (up to 2 years)
Control
single-arm (two cohorts: ≥3L and ≥2L)

Population

MSI-H/dMMR metastatic CRC, 2L+ (cohort A ≥3L; cohort B ≥2L), previously treated with fluoropyrimidine/oxaliplatin/irinotecan.

Key finding

Cohort A (n=61) ORR 33% (95% CI 21–46%), median OS 31.4 months (21.4–NR); Cohort B (n=63) ORR 33% (22–46%), median OS not reached; median PFS 2.3 and 4.1 months respectively (due to early progressors typical in IO response pattern); grade 3–4 TRAEs: 16% (A), 13% (B).

Source: PMID 31725351

Timeline

    Guideline citations

    • NCCN Colon (p.151)