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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) 29	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 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...
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 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...
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...
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 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
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
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 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
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
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...
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
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
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 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 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
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...
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
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

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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 \| DEU \| CAN \| AUS	1

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