Reference Detail

Ref Type

Journal Article

PMID

(38470950)

Authors

Kim KH, Cho S, Jeong Y, Baek ES, Lee C, Ryu HJ, Noh YS, Hong YH, Chung KY, Roh MR, Oh BH, Kim CG, Jung M, Shin SJ

Title

Exploring Molecular Genetic Alterations and RAF Fusions in Melanoma: A Belvarafenib Expanded Access Program in Patients with RAS/RAF-Mutant Melanoma.

Journal	Vol	Issue	Date	Pages	Journal Short Title
The oncologist			2024 Mar 12		Oncologist

URL

Abstract Text

Melanoma incidence is on the rise in East Asia, yet studies of the molecular landscape are lacking in this population. We examined patients with melanoma who underwent next-generation sequencing (NGS) at a single tertiary center in South Korea, focusing on patients harboring NRAS or RAF alterations who received belvarafenib, a pan-RAF dimer inhibitor, through the Expanded Access Program (EAP).Data were collected from 192 patients with melanoma who underwent NGS between November 2017 and May 2023. Variant call format data were obtained and annotated. Patients in the EAP received 450 mg twice daily doses of belvarafenib.Alterations in the RAS/RTK pathway were the most prevalent, with BRAF and NRAS alteration rates of 22.4% and 17.7%, respectively. NGS enabled additional detection of fusion mutations, including 6 BRAF and 1 RAF1 fusion. Sixteen patients with NRAS or RAF alterations received belvarafenib through the EAP, and disease control was observed in 50%, with 2 patients demonstrating remarkable responses.Our study highlights the value of NGS in detecting BRAF, NRAS mutations and RAF fusions, expanding possibilities for targeted therapies in malignant melanoma. Belvarafenib showed clinical benefit in patients harboring these alterations. Ongoing trials will provide further insights into the safety and efficacy of belvarafenib.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
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 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