KEYNOTE-158-PANC

NCT02628067 📎

Regimen

Experimental
Pembrolizumab 200 mg IV Q3W for up to 35 cycles (~2 years)
Control
single-arm / no comparator (historical 2L PDAC ORR <10%, mOS ~5-6 mo)

Population

Previously treated unresectable/metastatic PDAC with MSI-H or dMMR status (rare in PDAC, ~1%); pancreatic cohort n=22 within 233-pt non-CRC MSI-H analysis (Marabelle JCO 2020).

Key finding

Provided the pivotal evidence that led to FDA tissue-agnostic approval of pembrolizumab for MSI-H/dMMR solid tumors (2017 initial, KN-158 confirmed). For PDAC specifically, 18% ORR with remarkable durability (median DoR 13.4 mo) in a small subset — demonstrating that the rare MSI-H PDAC patient can achieve durable benefit that standard chemo cannot deliver. Supports universal MMR/MSI testing at PDAC diagnosis.

Source: PMID 31682550

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.65)