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Therapy Name | FCN-159 |
Synonyms | |
Therapy Description |
FCN-159 inhibits MAP2K1/2 (MEK1/2), potentially resulting in reduced proliferation and increased cell cycle arrest and apoptosis in tumor cells, and inhibition of tumor growth (Cancer Res 2020;80(16 Suppl):Abstract nr 1951). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
FCN-159 | FCN159|FCN 159 | MEK1 Inhibitor 26 MEK2 Inhibitor 24 | FCN-159 inhibits MAP2K1/2 (MEK1/2), potentially resulting in reduced proliferation and increased cell cycle arrest and apoptosis in tumor cells, and inhibition of tumor growth (Cancer Res 2020;80(16 Suppl):Abstract nr 1951). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
BRAF V600E | low grade glioma | predicted - sensitive | FCN-159 | Phase II | Actionable | In a Phase II trial, FCN-159 treatment was well tolerated and resulted in 6 partial responses, 9 minor responses, and 7 with stable disease in 22 pediatric patients with low-grade glioma harboring BRAF V600E (12/23), KIAA1549-BRAF (8/23), or NF1 mutations (3/23) (Ann Oncol (2023) 34 (suppl_2): S391-S392). | detail... |
NRAS mutant | Advanced Solid Tumor | predicted - sensitive | FCN-159 | Preclinical - Pdx | Actionable | In a preclinical study, FCN-159 inhibited tumor growth in patient-derived xenograft (PDX) models harboring NRAS mutations (Cancer Res 2020;80(16 Suppl):Abstract nr 1951). | detail... |
NRAS act mut | melanoma | predicted - sensitive | FCN-159 | Phase I | Actionable | In a Phase I trial (FCN-159-001), FCN-159 treatment was well tolerated in melanoma patients harboring NRAS activating mutations and resulted in an objective response rate (ORR) of 19% (4/21, all partial responses), a clinical benefit rate (CBR) of 52.4% (11/21), and a median progression-free survival (mPFS) of 3.8 mo across all doses tested, and a CBR of 50% (3/6), mPFS of 3.8 mo at the RP2D dose of 12mg (PMID: 36113242; NCT03932253). | 36113242 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04954001 | Phase Ib/II | FCN-159 | Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 | Active, not recruiting | USA | ESP | 1 |