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|Therapy Name||Binimetinib + Ribociclib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Binimetinib||Mektovi||ARRY-162|ARRY-438162|MEK162||MEK inhibitor (Pan) 22 MEK1 Inhibitor 20 MEK2 Inhibitor 18||Mektovi (binimetinib) inhibits MEK1 and MEK2 resulting in inhibition of growth factor-mediated signaling and decreased tumor cell proliferation (PMID: 23587417). Mektovi (binimetinib) in combination with Braftovi (encorafenib) is FDA approved for use in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation (FDA.gov).|
|Ribociclib||Kisqali||LEE011||CDK4/6 Inhibitor 11||Kisqali (ribociclib) is a dual CDK4/6 inhibitor, which may induce cell cycle arrest and reduce proliferation in cancer cells (PMID: 24045179). Kisqali (ribociclib) is FDA-approved in combination with an aromatase inhibitor in women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer, and in combination with Faslodex (fulvestrant) in postmenopausal women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|NRAS mutant||melanoma||sensitive||Binimetinib + Ribociclib||Phase Ib/II||Actionable||In a Phase Ib/II trial, the combination of Binimetinib (MEK162) and Kisqali (ribociclib) resulted in a partial response in 43% (6/14) and stable disease in 43% (6/14) of NRAS mutant melanoma patients (J Clin Oncol 32:5s, 2014 (Suppl;abstr 9009)).||detail...|
|NRAS mutant||melanoma||sensitive||Binimetinib + Ribociclib||Phase Ib/II||Actionable||In a Phase Ib trial, the combination of Binimetinib (MEK162) and Kisqali (ribociclib) resulted in a median progression-free survival of 6.7 months, a partial response in 25% (4/16), and stable disease in 44% (7/16) of NRAS mutant melanoma patients (J Clin Oncol 35, 2017 (suppl; abstr 9519)).||detail...|
|NRAS Q61X||melanoma||sensitive||Binimetinib + Ribociclib||Phase II||Actionable||In a Phase I/II trial, Kisqali (ribociclib) and Mektovi (binimetinib) combination treatment was well-tolerated and resulted in an overall response rate (ORR) of 19.5% (8/41, all PR), a disease control rate of 70.7% (29/41), a median duration of response of 10.3 months, median progression-free survival of 3.7 months, an overall survival (OS) of 11.3 months in patients with melanoma harboring NRAS mutations, and an ORR of 22.9% (16/70) in patients harboring NRAS Q61X (PMID: 35294522; NCT01781572).||35294522|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT01781572||Phase Ib/II||Binimetinib + Ribociclib||A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma||Completed||USA | ITA | DEU||2|