Therapy Detail

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Therapy Name Mirdametinib
Synonyms
Therapy Description

Gomekli (mirdametinib), a derivative of CI-1040, is a pan-MEK inhibitor, which inhibits activation of MAPK/ERK resulting in decreased tumor cell proliferation (PMID: 18952427, PMID: 32147669). Gomekli (mirdametinib) is FDA-approved for use in adult and pediatric patients 2 years and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Mirdametinib Gomekli PD0325901|PD 0325901|PD-901|PD-0325901 MEK inhibitor (Pan) 27 MEK1 Inhibitor 27 MEK2 Inhibitor 25 Gomekli (mirdametinib), a derivative of CI-1040, is a pan-MEK inhibitor, which inhibits activation of MAPK/ERK resulting in decreased tumor cell proliferation (PMID: 18952427, PMID: 32147669). Gomekli (mirdametinib) is FDA-approved for use in adult and pediatric patients 2 years and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF N486_P490del ovarian cancer sensitive Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, an ovarian cancer cell line harboring BRAF N486_P490del demonstrated sensitivity to Gomekli (mirdametinib), resulting in decreased cell viability in culture (PMID: 26996308). 26996308
BRAF V600E colorectal cancer sensitive Mirdametinib Preclinical Actionable In a preclinical study, Gomekli (mirdametinib) inhibited growth of colorectal cancer cell lines harboring BRAF V600E in culture (PMID: 26267534). 26267534
BRAF V600E colon cancer sensitive Mirdametinib Preclinical - Cell line xenograft Actionable In a preclinical study, Gomekli (mirdametinib) demonstrated antitumor activity against BRAF V600E colon cancer cell line xenografts (PMID: 16273091). 16273091
NRAS G75_E76insDSAMRDQYMRTG myelodysplastic/myeloproliferative neoplasm sensitive Mirdametinib Preclinical Actionable In a preclinical study, Gomekli (mirdametinib) decreased the accumulation of immature myeloid cells in a zebrafish model of myelodysplastic/myeloproliferative neoplasm harboring NRAS G75_E76insDSAMRDQYMRTG (PMID: 38522505). 38522505
NRAS Q61L acute myeloid leukemia predicted - sensitive Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, Gomekli (mirdametinib) treatment induced apoptosis and inhibited proliferation of an acute myeloid leukemia cell line harboring NRAS Q61L in culture (PMID: 28923853). 28923853
NRAS Q61R melanoma sensitive Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, Gomekli (mirdametinib) treatment induced cell cycle arrest and inhibited growth of melanoma cells harboring NRAS Q61R in culture (PMID: 25422890). 25422890
NRAS mutant melanoma no benefit Mirdametinib Preclinical - Cell line xenograft Actionable In a preclinical study, Gomekli (mirdametinib) treatment resulted in stable tumor growth in melanoma cell line xenograft models harboring an NRAS mutation, however, growth later ensued and thus, demonstrates a lack of benefit (PMID: 27488531). 27488531
BRAF N486_P490del melanoma sensitive Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, a melanoma cell line harboring BRAF N486_P490del demonstrated sensitivity to Gomekli (mirdametinib), resulting in decreased cell viability in culture (PMID: 26996308). 26996308
BRAF V600E glioblastoma conflicting Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, Gomekli (mirdametinib) inhibited growth of glioblastoma cell lines harboring BRAF V600E in culture (PMID: 38714355). 38714355
BRAF V600E glioblastoma conflicting Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, a glioblastoma cell line harboring BRAF V600E demonstrated a decreased response to treatment with Gomekli (mirdametinib), demonstrating increased viability of CD133 positive cells in culture (PMID: 26573800). 26573800
BRAF V600E MAP2K1 I103N melanoma resistant Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, overexpression of MAP2K1 I103N in melanoma cells harboring BRAF V600E resulted in insensitivity to growth inhibition by Gomekli (mirdametinib) in cell culture (PMID: 26267534). 26267534
MAP2K1 Q56P lung adenocarcinoma sensitive Mirdametinib Preclinical Actionable In a preclinical study, a lung adenocarcinoma cell line harboring MAP2K1 Q56P demonstrated sensitivity to Gomekli (mirdametinib), resulting in decreased cell viability (PMID: 26582713). 26582713
KIT W557_K558del gastrointestinal stromal tumor sensitive Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, Gomekli (mirdametinib) treatment inhibited Erk phosphorylation and decreased expression of ETV1 and CXCR4 in gastrointestinal stromal tumor cells harboring KIT W557_K558del (PMID: 26936919). 26936919
BRAF V600E melanoma conflicting Mirdametinib Preclinical - Cell line xenograft Actionable In a preclinical study, a melanoma cell line xenograft model harboring BRAF V600E treated with Gomekli (mirdametinib) demonstrated stable tumor growth, but by day 44, growth ensued and thus, demonstrated no benefit (PMID: 27488531). 27488531
BRAF V600E melanoma conflicting Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, Gomekli (mirdametinib) inhibited growth of melanoma cell lines harboring BRAF V600E in culture (PMID: 26267534). 26267534
BRAF V600E melanoma conflicting Mirdametinib Preclinical - Cell line xenograft Actionable In a preclinical study, Gomekli (mirdametinib) treatment induced cell cycle arrest and inhibited growth of melanoma cells harboring BRAF V600E in culture (PMID: 25422890). 25422890
BRAF V600E MAP2K1 L115P melanoma resistant Mirdametinib Preclinical Actionable In a preclinical study, overexpression of MAP2K1 L115P in melanoma cells harboring BRAF V600E resulted in insensitivity to growth inhibition by Gomekli (mirdametinib) in cell culture (PMID: 26267534). 26267534

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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT07237100 Phase II Mirdametinib Mirdametinib in Patients With Advanced NF1-mutant Melanoma Recruiting USA 0
NCT03962543 Phase II Mirdametinib MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas (ReNeu) Active, not recruiting USA 0
NCT04923126 Phase Ib/II Mirdametinib SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma Recruiting USA 0
NCT01347866 Phase I Gedatolisib Mirdametinib Irinotecan Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer Terminated USA | ITA | ESP | CAN 0
NCT02096471 Phase II Mirdametinib MEK Inhibitor PD-0325901 Trial in Adolescents and Adults With NF1 Completed USA 0


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