Missing content? – Request curation!
Request curation for specific Genes, Variants, or PubMed publications.
Have questions, comments, or suggestions? - Let us know!
Email us at : ckbsupport@jax.org
Therapy Name | Tunlametinib |
Synonyms | |
Therapy Description |
Tunlametinib (HL-085) is a MEK inhibitor that may inhibit proliferation of tumor cells (Cancer Res 2019;79(13 Suppl):Abstract nr 4753). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Tunlametinib | HL-085|HL085|HL 085 | MEK inhibitor (Pan) 24 | Tunlametinib (HL-085) is a MEK inhibitor that may inhibit proliferation of tumor cells (Cancer Res 2019;79(13 Suppl):Abstract nr 4753). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
NRAS G12D | melanoma | predicted - sensitive | Tunlametinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tunlametinib (HL-085) treatment resulted in a confirmed objective response rate of 34.7%, a median progression-free survival of 4.2 months, and 1-year survival rate of 57.2% in patients with advanced melanoma harboring NRAS mutations including NRAS Q61R (40%), Q61K (29.5%), and G12D (9.5%) (J Clin Oncol 41, 2023 (suppl 16; abstr 9510); NCT05217303). | detail... |
NRAS act mut | melanoma | predicted - sensitive | Tunlametinib | Phase I | Actionable | In a Phase I trial, Tunlametinib (HL-085) treatment demonstrated acceptable tolerability and resulted in an objective response rate (ORR) of 14.3% (6/42; all partial responses), a disease control rate (DCR) of 78.6%, and a median progression-free survival (PFS) of 3.0 months in patients with advanced melanoma harboring NRAS mutations, and an ORR of 26.7% (4/15), a DCR of 86.7%, and median PFS of 3.6 months at the recommended Phase II dose (PMID: 36600247; NCT03973151). | 36600247 |
NRAS G12S | melanoma | predicted - sensitive | Tunlametinib | Case Reports/Case Series | Actionable | In a Phase I trial, Tunlametinib (HL-085) treatment demonstrated safety and preliminary efficacy in patients with advanced melanoma harboring NRAS mutations, resulting in a partial response in a patient harboring NRAS G12S who remained on treatment for 36 weeks (PMID: 36600247; NCT03973151). | 36600247 |
NRAS Q61K | melanoma | predicted - sensitive | Tunlametinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tunlametinib (HL-085) treatment resulted in a confirmed objective response rate of 34.7%, a median progression-free survival of 4.2 months, and 1-year survival rate of 57.2% in patients with advanced melanoma harboring NRAS mutations including NRAS Q61R (40%), Q61K (29.5%), and G12D (9.5%) (J Clin Oncol 41, 2023 (suppl 16; abstr 9510); NCT05217303). | detail... |
NRAS Q61R | melanoma | predicted - sensitive | Tunlametinib | Case Reports/Case Series | Actionable | In a Phase I trial, Tunlametinib (HL-085) treatment demonstrated safety and preliminary efficacy in patients with advanced melanoma harboring NRAS mutations, resulting in an objective response rate of 37.5% (3/8), a disease control rate of 75% (6/8), and a median progression-free survival of 114.0 days in patients harboring NRAS Q61R at the recommended Phase II dose (PMID: 36600247; NCT03973151). | 36600247 |
NRAS Q61R | melanoma | predicted - sensitive | Tunlametinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tunlametinib (HL-085) treatment resulted in a confirmed objective response rate of 34.7%, a median progression-free survival of 4.2 months, and 1-year survival rate of 57.2% in patients with advanced melanoma harboring NRAS mutations including NRAS Q61R (40%), Q61K (29.5%), and G12D (9.5%) (J Clin Oncol 41, 2023 (suppl 16; abstr 9510); NCT05217303). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04683354 | Phase I | Tunlametinib | Phase I Study of HL-085 in Patients With Advanced Solid Tumor Tumors | Completed | USA | 0 |
NCT03976050 | Phase I | Tunlametinib | Phase I Study of HL-085 in Patients With Advanced Solid Tumors | Terminated | USA | 0 |