Therapy Detail
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| Therapy Name | Belvarafenib |
| Synonyms | |
| Therapy Description |
Belvarafenib (HM95573) selectively inhibits RAF dimer formation, leading to inhibition of ARAF, BRAF, and CRAF activity, and potentially resulting in tumor growth inhibition (PMID: 33953400). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Belvarafenib | HM95573|GDC-5573|RO7223619 | RAF Inhibitor (Pan) 28 | Belvarafenib (HM95573) selectively inhibits RAF dimer formation, leading to inhibition of ARAF, BRAF, and CRAF activity, and potentially resulting in tumor growth inhibition (PMID: 33953400). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| BRAF class 3 | Advanced Solid Tumor | no benefit | Belvarafenib | Phase II | Actionable | In a Phase II trial (TAPISTRY), Belvarafenib (HM95573) treatment did not result in any confirmed objective responses in patients with advanced solid tumors harboring BRAF class III alterations, with a clinical benefit rate of 8.7% (2/23), 34.8% (8/23) with stable disease, a median progression-free survival of 2.0 months, and a median overall survival of 8.2 months (Ann Oncol (2024) 35 (Suppl_2): S498-S499; NCT04589845). | detail... |
| BRAF V600E | colorectal cancer | predicted - sensitive | Belvarafenib | Case Reports/Case Series | Actionable | In a Phase I trial, Belvarafenib (HM95573) treatment in a colorectal cancer patient harboring BRAF V600E led to a tumor reduction of 39% after 8 weeks of treatment and a confirmed partial response at 12 weeks, and response to treatment was maintained for 8 weeks (PMID: 33953400; NCT03118817). | 33953400 |
| BRAF mutant | colorectal cancer | sensitive | Belvarafenib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Belvarafenib (HM95573) inhibited growth of BRAF mutant colorectal cancer cell lines in culture and in cell line xenograft models (Cancer Res 2015;75(15 Suppl):Abstract nr 2607). | detail... |
| BRAF class 2 | Advanced Solid Tumor | no benefit | Belvarafenib | Phase II | Actionable | In a Phase II trial (TAPISTRY), Belvarafenib (HM95573) treatment did not result in any confirmed objective responses in patients with advanced solid tumors harboring BRAF class II alterations (including mutations, fusion positive, or intragenic deletions), with a clinical benefit rate of 3.8% (1/26), 42.3% (11/26) with stable disease, a median progression-free survival of 2.1 months, and a median overall survival of 4.8 months (Ann Oncol (2024) 35 (Suppl_2): S498-S499; NCT04589845). | detail... |
| NRAS mutant | melanoma | predicted - sensitive | Belvarafenib | Case Reports/Case Series | Actionable | In a Phase I trial, Belvarafenib (HM95573) treatment resulted in an unconfirmed partial response in a patient with NRAS mutant melanoma (Journal of Clinical Oncology 34, no. 15_suppl (May 20 2016) 2570-2570; NCT02405065). | detail... |
| NRAS mutant | melanoma | predicted - sensitive | Belvarafenib | Phase I | Actionable | In Phase I trials, Belvarafenib (HM95573) treatment resulted in partial response in 44% (4/9) of patients with NRAS-mutant melanoma in a dose escalation study, and partial response in 22% (2/9) of NRAS-mutant melanoma patients in a dose expansion study (J Clin Oncol 37, 2019 (suppl; abstr 3000); NCT02405065, NCT03118817). | detail... |
| NRAS Q61L | mucosal melanoma | predicted - sensitive | Belvarafenib | Case Reports/Case Series | Actionable | In a clinical case study, Belvarafenib (HM95573) treatment resulted in a partial response with a progression-free survival of 6.2 months in a mucosal melanoma patient harboring NRAS Q61L (PMID: 38470950). | 38470950 |
| BRAF D594G | mucosal melanoma | predicted - sensitive | Belvarafenib | Case Reports/Case Series | Actionable | In a clinical case study, Belvarafenib (HM95573) treatment resulted in a partial response ongoing at 8.5 months in a mucosal melanoma patient harboring BRAF D594G (PMID: 38470950). | 38470950 |
| BRAF mutant | thyroid cancer | sensitive | Belvarafenib | Preclinical - Cell culture | Actionable | In a preclinical study, Belvarafenib (HM95573) inhibited growth of BRAF mutant thyroid cancer cells in culture (Cancer Res 2015;75(15 Suppl):Abstract nr 2607). | detail... |
| BRAF G534D NRAS Q61L | melanoma | resistant | Belvarafenib | Preclinical - Cell culture | Actionable | In a preclinical study, expression of BRAF G534D in a melanoma cell line harboring NRAS Q61L conferred resistance to treatment with Belvarafenib (HM95573) in culture (PMID: 33953400). | 33953400 |
| NRAS Q61K | melanoma | predicted - sensitive | Belvarafenib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Belvarafenib (HM95573) treatment led to inhibition of tumor growth in a melanoma cell line xenograft model harboring NRAS Q61K (PMID: 33953400). | 33953400 |
| NRAS Q61R | Advanced Solid Tumor | sensitive | Belvarafenib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing NRAS Q61R were sensitive to treatment with Belvarafenib (HM95573) in culture, demonstrating decreased cell viability (PMID: 33953400). | 33953400 |
| NRAS Q61R | melanoma | predicted - sensitive | Belvarafenib | Case Reports/Case Series | Actionable | In a Phase I trial, Belvarafenib (HM95573) treatment in a melanoma patient harboring NRAS Q61R led to a tumor reduction of 84% after 24 weeks of treatment and a confirmed partial response at 12 weeks, and response to treatment was maintained for 40 weeks (PMID: 33953400; NCT03118817). | 33953400 |
| NRAS G12A | melanoma | predicted - sensitive | Belvarafenib | Case Reports/Case Series | Actionable | In a clinical case study, Belvarafenib (HM95573) treatment resulted in a partial response with a progression-free survival of 4.2 months in a melanoma patient harboring NRAS G12A (PMID: 38470950). | 38470950 |
| BRAF V600E | melanoma | predicted - sensitive | Belvarafenib | Preclinical - Cell culture | Actionable | In a preclinical study, Belvarafenib (HM95573) treatment led to inhibition of tumor growth in a melanoma cell line xenograft model harboring BRAF V600E (PMID: 33953400). | 33953400 |
| BRAF L485_P490delinsFS | Advanced Solid Tumor | predicted - sensitive | Belvarafenib | Preclinical - Biochemical | Actionable | In a preclinical study, Belvarafenib (HM95573) inhibited Mek and Erk phosphorylation in cells expressing BRAF L485_P490delinsFS in culture (PMID: 37656784). | 37656784 |
| NRAS mutant | leukemia | sensitive | Belvarafenib | Preclinical - Cell culture | Actionable | In a preclinical study, Belvarafenib (HM95573) inhibited growth of NRAS mutant leukemia cells in culture (Cancer Res 2015;75(15 Suppl):Abstract nr 2607). | detail... |
| BRAF V600E | high grade glioma | predicted - sensitive | Belvarafenib | Preclinical - Cell culture | Actionable | In a preclinical study, Belvarafenib (HM95573) treatment led to inhibition of cell viability in a patient-derived glioma cell line harboring BRAF V600E in culture (PMID: 34433654). | 34433654 |
| BRAF mutant | melanoma | predicted - sensitive | Belvarafenib | Phase I | Actionable | In Phase I trials, Belvarafenib (HM95573) treatment resulted in partial response in a patients with BRAF-mutant melanoma in a dose escalation study, and partial response in 33% (2/6) of BRAF-mutant melanoma patients in a dose expansion study (J Clin Oncol 37, 2019 (suppl; abstr 3000); NCT02405065, NCT03118817). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04835805 | Phase I | Belvarafenib + Cobimetinib + Nivolumab Belvarafenib + Cobimetinib Belvarafenib | A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma. | Active, not recruiting | USA | NOR | DEU | CAN | AUS | 1 |
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