KEYNOTE-158 — Phase 2 Basket Study of Pembrolizumab in Patients With Advanced Solid Tumors (MSI-H/dMMR and TMB-High Cohorts)

Phase 2 · 2020 · Solid Tumors, Endometrial Cancer, Cervical Cancer, Small Cell Lung Cancer

Design

Tumor-agnostic basket trial with multiple disease cohorts, including prespecified MSI-high/dMMR and tumor mutational burden-high (TMB >=10 mut/Mb) analyses.

Population

Previously treated advanced solid tumors, including MSI-H/dMMR non-colorectal cancers and TMB-high tumors.

Primary Endpoint

objective response rate (ORR)

Key Result

ORR ~34% in MSI-H/dMMR solid tumors with durable responses; ORR ~29% in TMB-high tumors.

Guideline Impact

Basis for tissue-agnostic pembrolizumab approval in MSI-H/dMMR (2017) and TMB-high (2020) solid tumors