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Molecular Profile MLH1 negative
Therapy Ipilimumab + Nivolumab
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 Ipilimumab + Nivolumab Guideline Actionable Yervoy (ipilimumab) in combination with Opdivo (nivolumab) is included in guidelines as second-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 Ipilimumab + Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 8HW) that supported FDA approval, Opdivo (nivolumab) and Yervoy (ipilimumab) combination treatment improved progression-free survival (nor reached vs 39.3 mo, HR 0.62, p=0.0003) compared to Opdivo (nivolumab) in adult and pediatric patients (>/=12 yo) with unresectable or metastatic DNA mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) or microsatellite instability-high (MSI-H) colorectal cancer (PMID: 39874977; NCT04008030). 39874977 detail... detail...
MLH1 negative colorectal cancer sensitive Ipilimumab + Nivolumab FDA approved Actionable In a Phase II trial (CheckMate 142) that supported FDA approval, Opdivo (nivolumab) and Yervoy (ipilimumab) combination treatment resulted in an objective response rate of 54.6% (65/119, 4 complete response, 61 partial response) and disease control over 12 weeks in 80% of patients with microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) metastatic colorectal cancer (PMID: 29355075; NCT02060188). detail... 29355075 detail...
MLH1 negative colorectal cancer sensitive Ipilimumab + Nivolumab Guideline Actionable Yervoy (ipilimumab) in combination with Opdivo (nivolumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) as a second-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) who progressed on first-line chemotherapy (PMID: 37236086; ESMO.org). 37236086 detail...
PubMed Id Reference Title Details
(29355075) Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer. Full reference...
ESMO Clinical Practice Guidelines Full reference...
ESMO Clinical Practice Guidelines Full reference...
Opdivo (nivolumab) FDA Drug Label Full reference...
Opdivo (nivolumab) FDA Drug Label Full reference...
Yervoy (ipilimumab) FDA Drug Label Full reference...
Yervoy (ipilimumab) FDA Drug Label 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...
(39874977) Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): a randomised, open-label, phase 3 trial. Full reference...