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PMID
Authors
Title Yervoy (ipilimumab) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Ipilimumab Ipilimumab 7 92
Drug Name Trade Name Synonyms Drug Classes Drug Description
Ipilimumab Yervoy BMS-734016 CTLA4 Antibody 33 Immune Checkpoint Inhibitor 150 Yervoy (ipilimumab) is an antibody that binds to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), causing increased T-cell activation (PMID: 28891423). Yervoy (ipilimumab) is FDA approved for use in patients with metastatic melanoma, including patients 12 years or older, and in combination with Opdivo (nivolumab) for intermediate or poor-risk renal cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (including patients 12 years or older), hepatocellular carcinoma previously treated with Nexavar (sorafenib), in combination with Opdivo (nivolumab) as first-line therapy in patients with PD-L1-positive (>=1%) metastatic non-small cell lung cancer without EGFR or ALK alterations, and in combination with Opdivo (nivolumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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...
PMS2 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). 29355075 detail... detail...
PMS2 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). detail... detail... 39874977
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...
PMS2 negative colorectal cancer sensitive Nivolumab FDA approved Actionable In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) 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: 28734759; NCT02060188). 28734759 detail... detail...
MSH2 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). 29355075 detail... detail...
MLH1 negative colorectal cancer sensitive Nivolumab FDA approved Actionable In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) 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: 28734759; NCT02060188). detail... 28734759 detail...
MSH6 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... detail... 29355075
MSH2 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...
MSH6 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...
MSH6 negative colorectal cancer sensitive Nivolumab FDA approved Actionable In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) 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: 28734759; NCT02060188). 28734759 detail... detail...
MSH2 negative colorectal cancer sensitive Nivolumab FDA approved Actionable In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) 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: 28734759; NCT02060188). 28734759 detail... detail...