Therapy Detail
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| Therapy Name | Mirdametinib + Palbociclib |
| Synonyms | |
| Therapy Description | |
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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). |
| Palbociclib | Ibrance | PD0332991|PD-0332991 | CDK4/6 Inhibitor 14 | Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| BRAF V600E | colorectal carcinoma | no benefit | Mirdametinib + Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Ibrance (palbociclib) and Gomekli (mirdametinib) demonstrated antagonism in a colorectal carcinoma cell line harboring BRAF V600E in culture (PMID: 37326340). | 37326340 |
| PIK3CA E545G | colorectal adenocarcinoma | sensitive | Mirdametinib + Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Ibrance (palbociclib) and Gomekli (mirdametinib) synergistically inhibited growth of a colorectal adenocarcinoma cell line harboring PIK3CA E545G in culture (PMID: 37326340). | 37326340 |
| NRAS mutant | melanoma | sensitive | Mirdametinib + Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, the combination treatment of Gomekli (mirdametinib) and Ibrance (palbociclib) resulted in tumor regression in 33% (2/6) of melanoma xenograft models harboring an NRAS mutation (PMID: 27488531). | 27488531 |
| BRAF V600E | melanoma | sensitive | Mirdametinib + Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, the combination treatment of Gomekli (mirdametinib) and Ibrance (palbociclib) resulted in significant tumor regression in melanoma cell line xenograft models harboring BRAF V600E and demonstrated a 56% (5/9) complete response rate (PMID: 27488531). | 27488531 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02022982 | Phase Ib/II | Mirdametinib + Palbociclib | PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors | Completed | USA | 0 |
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