Therapy Detail

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Therapy Name Belvarafenib + Cobimetinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Belvarafenib HM95573|GDC-5573|RO7223619 RAF Inhibitor (Pan) 27 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).
Cobimetinib Cotellic GDC-0973 MEK inhibitor (Pan) 24 MEK1 Inhibitor 26 MEK2 Inhibitor 24 Cotellic (cobimetinib) is an allosteric inhibitor of MEK1/2, resulting in inhibition of extracellular signal-related kinase 2 (ERK2) phosphorylation and activation and decreased tumor cell proliferation (PMID: 22084396, PMID: 27956260). Cotellic (cobimetinib) is FDA approved for use in combination with Zelboraf (vemurafenib) in melanoma patients harboring BRAF V600E or V600K (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
NRAS Q61L melanoma sensitive Belvarafenib + Cobimetinib Preclinical - Cell line xenograft Actionable In a preclinical study, the addition of Cotellic (cobimetinib) to treatment with Belvarafenib (HM95573) in melanoma cell lines harboring NRAS Q61L resulted in greater inhibition of cell proliferation in culture compared to single agent alone, and led to decreased tumor volume, with increased efficacy and response durability in a cell line xenograft model (PMID: 33953400). 33953400
BRAF V600X Advanced Solid Tumor predicted - sensitive Belvarafenib + Cobimetinib Phase I Actionable In a Phase Ib trial, combination treatment with Belvarafenib (HM95573) and Cotellic (cobimetinib) was well-tolerated and demonstrated safety, and led to a confirmed partial response in 33.3% (3/9) solid tumor patients harboring BRAF V600 mutations (Annals of Oncology 32 (2021): S595; NCT03284502). detail...
BRAF fusion Advanced Solid Tumor predicted - sensitive Belvarafenib + Cobimetinib Phase I Actionable In a Phase I trial (HM-RAFI-103), Belvarafenib (HM95573) and Cotellic (cobimetinib) combination therapy demonstrated preliminary activity in patients with advanced solid tumors harboring BRAF fusions, resulting in an objective response rate of 60% (9/15, all partial responses), a disease control rate of 93.3% (14/15), with a median progression-free survival of 13.7 months, and a median duration of response of 12 months (Ann Oncol 34 (2023): S465; NCT03284502). detail...
BRAF V600D melanoma sensitive Belvarafenib + Cobimetinib Preclinical - Cell culture Actionable In a preclinical study, the addition of Cotellic (cobimetinib) to treatment with Belvarafenib (HM95573) in a melanoma cell line harboring BRAF V600D resulted in greater inhibition of cell proliferation in culture compared to single agent alone (PMID: 33953400). 33953400
NRAS mutant melanoma predicted - sensitive Belvarafenib + Cobimetinib Phase I Actionable In a Phase I trial, Belvarafenib (HM95573) and Cotellic (cobimetinib) combination therapy was tolerable, and resulted in a response rate of 38% (5/13, 5 partial response) in patients with melanoma harboring NRAS mutations, with a median progression-free survival of 7.3 months (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 3007-3007; NCT03284502). 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 | DEU | CAN | AUS 2


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