Profile Response Detail

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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...