Therapy Detail
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| Therapy Name | Tunlametinib + Vemurafenib |
| Synonyms | |
| Therapy Description | |
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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). | |
| Vemurafenib | Zelboraf | RO5185426|PLX4032 | RAF Inhibitor (Pan) 28 | Zelboraf (vemurafenib) inhibits BRAF V600E, wild-type BRAF, ARAF, and CRAF (PMID: 20179705), which may result in an inhibition of the MAPK signaling pathway resulting in a reduction of tumor cell proliferation (PMID: 20823850). Zelboraf (vemurafenib) is FDA approved for BRAF V600E-mutant melanoma and for BRAF V600-positive Erdheim-Chester disease (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| BRAF V600X | lung non-small cell carcinoma | predicted - sensitive | Tunlametinib + Vemurafenib | Phase I | Actionable | In a Phase I trial, the combination of Tunlametinib (HL-085) and Zelboraf (vemurafenib) demonstrated safety and resulted in an objective response rate of 60.6% (20/33), a median duration of response of 11.3 months, and a median progression free survival of 11.7 months in patients with advanced non-small cell lung cancer harboring a BRAF V600 mutation (Ann Oncol (2023) 34 (suppl_2): S790; NCT03781219). | detail... |
| BRAF V600E | melanoma | sensitive | Tunlametinib + Vemurafenib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, treatment with the combination of Tunlametinib (HL-085) and Zelboraf (vemurafenib) synergistically inhibited proliferation of a melanoma cell line harboring BRAF V600E in culture, and synergistically inhibited tumor growth in a cell line xenograft model (PMID: 37808191). | 37808191 |
| BRAF V600X | colorectal cancer | predicted - sensitive | Tunlametinib + Vemurafenib | Phase I | Actionable | In a Phase I trial, the combination of Tunlametinib (HL-085) and Zelboraf (vemurafenib) demonstrated safety and resulted in an objective response rate of 25.0% (6/24), a median duration of response of 5.5 months, and a median progression free survival of 6.2 months in patients with advanced colorectal cancer harboring a BRAF V600 mutation (Ann Oncol (2023) 34 (suppl_2): S790; NCT03781219). | detail... |
| BRAF V600E | colorectal cancer | sensitive | Tunlametinib + Vemurafenib | Preclinical - Cell culture | Actionable | In a preclinical study, treatment with the combination of Tunlametinib (HL-085) and Zelboraf (vemurafenib) synergistically inhibited proliferation of a colorectal cancer cell line harboring BRAF V600E in culture (PMID: 37808191). | 37808191 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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