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Molecular Profile MLH1 negative
Therapy Pembrolizumab
Indication/Tumor Type colorectal cancer
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
MLH1 negative colorectal cancer sensitive Pembrolizumab FDA approved Actionable In a Phase III (KEYNOTE-177) trial that supported FDA approval, Keytruda (pembrolizumab) treatment as first-line therapy significantly improved median progression-free survival (16.5 vs 8.2 mo, HR=0.60, p=0.0002) compared to chemotherapy in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) colorectal cancer (PMID: 33264544; NCT02563002). 33264544 detail...
MLH1 negative colorectal cancer sensitive Pembrolizumab Guideline Actionable Keytruda (pembrolizumab) is included in guidelines as first-line therapy for patients with metastatic colorectal cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 36307056; ESMO.org). 36307056 detail...
MLH1 negative colorectal cancer sensitive Pembrolizumab Guideline Actionable Keytruda (pembrolizumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) as first-line therapy for patients with advanced or metastatic colorectal cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 37236086; ESMO.org). detail... 37236086
PubMed Id Reference Title Details
ESMO Clinical Practice Guidelines Full reference...
ESMO Clinical Practice Guidelines Full reference...
Keytruda (pembrolizumab) FDA Drug Label Full reference...
(33264544) Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer. Full reference...
(36307056) Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Full reference...
(37236086) Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with metastatic colorectal cancer. Full reference...