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    DRUG CLASS:

    MEK2 inhibitor

    Related drugs:
    1m
    A single center, single arm, prospective clinical study initiated by a researcher on the efficacy and safety of FCN-159 table (ChiCTR2500109679)
    P=N/A, N=20, Completed, Beijing Childrens Hospital,Capital Medical University; Beijing Childrens Hospital,Capital Medical University
    New trial
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    luvometinib (FCN-159)
    1m
    Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas. (PubMed, Target Oncol)
    Luvometinib had a manageable safety profile in pediatric patients with unresectable NF1-related PN. Encouraging preliminary efficacy was observed, particularly among patients receiving the RP2D of 5 mg/m2, supporting further investigation of luvometinib in this setting.
    P1 data • Journal
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    NF1 (Neurofibromin 1)
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    luvometinib (FCN-159)
    3ms
    IMM1104-101: A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=209, Active, not recruiting, Immuneering Corporation | Recruiting --> Active, not recruiting | N=320 --> 209
    Enrollment closed • Enrollment change
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    KRAS (KRAS proto-oncogene GTPase) • HRAS (Harvey rat sarcoma viral oncogene homolog) • APC (APC Regulator Of WNT Signaling Pathway)
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    KRAS mutation • NRAS mutation • KRAS wild-type • RAS mutation • HRAS mutation
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    Keytruda (pembrolizumab) • Tafinlar (dabrafenib) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • atebimetinib (IMM-1-104)
    4ms
    E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma (clinicaltrials.gov)
    P1, N=13, Terminated, Mayo Clinic | N=25 --> 13 | Trial completion date: Dec 2026 --> Jun 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Nov 2024; Financial issues
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    BRAF mutation • BRAF V600
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    Tafinlar (dabrafenib) • E6201
    4ms
    Luvometinib: First Approval. (PubMed, Drugs)
    In May 2025, luvometinib was approved in china for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms and for the treatment of paediatric patients aged ≥ 2 years with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. This article summarizes the milestones in the development of luvometinib leading to this first approval for the treatment of adult patients with LCH/histiocytic tumours and children and adolescents aged ≥ 2 years with NF1 with symptomatic, inoperable PN.
    Journal
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    NF1 (Neurofibromin 1)
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    Ivesa (firmonertinib) • luvometinib (FCN-159)
    4ms
    Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors (clinicaltrials.gov)
    P2, N=30, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting
    Enrollment open
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    luvometinib (FCN-159)
    6ms
    Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov)
    P1/2, N=65, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
    New P1/2 trial
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    Ivesa (firmonertinib) • luvometinib (FCN-159)
    6ms
    FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration (clinicaltrials.gov)
    P3, N=102, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
    New P3 trial
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    BRAF (B-raf proto-oncogene)
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    carboplatin • temozolomide • Ivesa (firmonertinib) • luvometinib (FCN-159) • vindesine
    7ms
    Targeting the MAPK Pathway for NRAS Mutant Melanoma: From Mechanism to Clinic. (PubMed, Br J Dermatol)
    In recent years, significant clinical advancements have been achieved by targeting the NRAS-MAPK pathway, with novel therapies such as the MEK inhibitor tunlametinib and the combination therapy of the pan-RAF inhibitor naporafenib with trametinib leading the way. In this review, we will systematically summarize the recent advances in the direct targeting of mutant NRAS proteins and their downstream RAF and MEK proteins, as well as targeting the MAPK pathway in combination with other therapeutic targets, including the immunotherapy, to treat NRAS mutant melanoma. Additionally, we will further discuss the current issues and emerging countermeasures related to targeted therapy for NRAS mutant melanoma.
    Journal • IO biomarker
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    NRAS (Neuroblastoma RAS viral oncogene homolog)
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    NRAS mutation
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    Mekinist (trametinib) • Kolupin (tunlametinib) • naporafenib (ERAS-254)
    8ms
    IMM1104-101: A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=320, Recruiting, Immuneering Corporation | N=210 --> 320
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • HRAS (Harvey rat sarcoma viral oncogene homolog) • APC (APC Regulator Of WNT Signaling Pathway)
    |
    KRAS mutation • NRAS mutation • KRAS wild-type • RAS mutation • HRAS mutation
    |
    Keytruda (pembrolizumab) • Tafinlar (dabrafenib) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • atebimetinib (IMM-1-104)
    8ms
    An Exploratory Study to Evaluate the Efficacy and Safety of FCN-159 in Patients With Brain Arteriovenous Malformations (clinicaltrials.gov)
    P2, N=10, Recruiting, Xuanwu Hospital, Beijing
    New P2 trial
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    luvometinib (FCN-159)
    8ms
    FCN-159-008: A phase II multicenter, open-label, single-arm study to evaluate the efficacy and safety of FCN-159 in adolescent and adult patients with extracranial arteriovenous malformation (ChiCTR2500096055)
    P2, N=35, Not yet recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Shanghai Fosun Pharmaceutical (Group) Limited by Shar
    New P2 trial
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • PTEN (Phosphatase and tensin homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • SMAD4 (SMAD family member 4) • MAP2K2 (Mitogen-activated protein kinase kinase 2) • EPHB4 (EPH receptor B4) • RASA1 (RAS P21 Protein Activator 1)
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    luvometinib (FCN-159)