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Therapy Name Mirdametinib
Synonyms
Therapy Description

PD-0325901, 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).

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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) 26 MEK1 Inhibitor 26 MEK2 Inhibitor 24 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
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 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
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
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
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
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
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 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
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 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
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
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 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 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, 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
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
STK11 inact mut Advanced Solid Tumor sensitive Mirdametinib Preclinical - Cell culture Actionable In a preclinical study, the presence of an STK11 loss expression signature, which correlates with STK11 inactivating mutations, was associated with increased sensitivity to Gomekli (mirdametinib) in human tumor cell lines in culture (PMID: 27821489). 27821489
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04923126 Phase Ib/II Mirdametinib SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma 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
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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