KEYNOTE-177

NCT02563002 📎

Regimen

Experimental
Pembrolizumab 200 mg Q3W (up to 35 cycles)
Control
Investigator's choice chemotherapy (mFOLFOX6 or FOLFIRI ± bevacizumab or cetuximab)

Population

MSI-H/dMMR metastatic CRC, 1L, centrally confirmed, previously untreated for metastatic disease.

Key finding

Pembrolizumab vs chemotherapy (5-FU-based ± bev/cet) at 32.4-month follow-up: PFS HR 0.60 (95% CI 0.45–0.80; P=0.0002), median PFS 16.5 vs 8.2 months; ORR 43.8% vs 33.1%; responders with ongoing response at 24 months: 83% (pembro) vs 35% (chemo); OS data immature at primary analysis; grade ≥3 TRAEs: 22% vs 66%.

Source: PMID 33264544

Timeline

    Guideline citations

    • NCCN Colon (p.6)
    • NCCN Rectal (p.7)