Therapy Detail
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| 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). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Tunlametinib | HL-085|HL085|HL 085 | MEK inhibitor (Pan) 26 | Tunlametinib (HL-085) is a MEK inhibitor that may inhibit proliferation of tumor cells (Cancer Res 2019;79(13 Suppl):Abstract nr 4753). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| NRAS Q61X | melanoma | predicted - sensitive | Tunlametinib | Phase II | Actionable | In a Phase II trial, Tunlametinib (HL-085) treatment resulted in a confirmed objective response rate (ORR) of 35.8% (34/95, all partial responses), a median progression-free survival of 4.2 months, disease control rate of 72.6% (69/95), median duration of response of 6.1 months, and median overall survival of 13.7 months in Chinese patients with advanced melanoma harboring NRAS mutations, with an ORR of 41.3% in patients with an NRAS Q61 mutation (n=75) (PMID: 38479118; NCT05217303). | 38479118 |
| NRAS act mut | melanoma | predicted - sensitive | Tunlametinib | Phase II | Actionable | In a Phase II trial, Tunlametinib (HL-085) treatment demonstrated safety and activity in Chinese patients with advanced melanoma harboring NRAS mutations (including mutations at Q61, G12, and G13), with an objective response rate of 35.8% (34/95, all partial responses), a median progression-free survival of 4.2 months, disease control rate of 72.6% (69/95), median duration of response of 6.1 months, and median overall survival of 13.7 months (PMID: 38479118; NCT05217303). | 38479118 |
| 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 G12X | melanoma | predicted - sensitive | Tunlametinib | Phase II | Actionable | In a Phase II trial, Tunlametinib (HL-085) treatment resulted in a confirmed objective response rate (ORR) of 35.8% (34/95, all partial responses), a median progression-free survival of 4.2 months, disease control rate of 72.6% (69/95), median duration of response of 6.1 months, and median overall survival of 13.7 months in Chinese patients with advanced melanoma harboring NRAS mutations, with an ORR of 13.3% in patients with an NRAS G12 mutation (n=15) (PMID: 38479118; NCT05217303). | 38479118 |
| 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 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 35.8% (34/95, all partial responses), a median progression-free survival of 4.2 months, disease control rate of 72.6% (69/95), median duration of response of 6.1 months, and median overall survival of 13.7 months in Chinese patients with advanced melanoma harboring NRAS mutations including NRAS Q61R (40%), Q61K (29.5%), and G12D (9.5%) (PMID: 38479118; NCT05217303). | 38479118 |
| BRAF V600E | melanoma | sensitive | Tunlametinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Tunlametinib (HL-085) inhibited viability and induced cell cycle arrest in melanoma cell lines harboring BRAF V600E in culture, and inhibited tumor growth in a cell line xenograft model (PMID: 37808191). | 37808191 |
| NRAS G13X | 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 (ORR) of 35.8% (34/95, all partial responses), a median progression-free survival of 4.2 months, disease control rate of 72.6% (69/95), median duration of response of 6.1 months, and median overall survival of 13.7 months in Chinese patients with advanced melanoma harboring NRAS mutations, with an ORR of 13.3% in patients with an NRAS G13 mutation (n=5) (PMID: 38479118; NCT05217303). | 38479118 |
| BRAF V600E | colorectal cancer | sensitive | Tunlametinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Tunlametinib (HL-085) inhibited viability of a colorectal cancer cell line harboring BRAF V600E in culture and inhibited tumor growth in a cell line xenograft model (PMID: 37808191). | 37808191 |
| 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 35.8% (34/95, all partial responses), a median progression-free survival of 4.2 months, disease control rate of 72.6% (69/95), median duration of response of 6.1 months, and median overall survival of 13.7 months in Chinese patients with advanced melanoma harboring NRAS mutations including NRAS Q61R (40%), Q61K (29.5%), and G12D (9.5%) (PMID: 38479118; NCT05217303). | 38479118 |
| 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 35.8% (34/95, all partial responses), a median progression-free survival of 4.2 months, disease control rate of 72.6% (69/95), median duration of response of 6.1 months, and median overall survival of 13.7 months in Chinese patients with advanced melanoma harboring NRAS mutations including NRAS Q61R (40%), Q61K (29.5%), and G12D (9.5%) (PMID: 38479118; NCT05217303). | 38479118 |
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| 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 |
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