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    DRUG:

    luvometinib (FCN-159)

    i
    Other names: FCN-159, FCN 159, FH1701
    Company:
    Fosun Pharma
    Drug class:
    MEK1 inhibitor, MEK2 inhibitor
    Related drugs:
    1m
    Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov)
    P1/2, N=160, Active, not recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Phase classification: P2 --> P1/2
    Phase classification
    |
    NF1 (Neurofibromin 1)
    |
    NF1 mutation
    |
    luvometinib (FCN-159)
    3ms
    A single-center, open, single-arm phase II clinical study: evaluation of the efficacy and safety of FCN-159 in selected NF2-associated nerve sheath tumors (ChiCTR2400086826)
    P2, N=30, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
    New P2 trial
    |
    luvometinib (FCN-159)
    4ms
    Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial
    |
    NF2 (Neurofibromin 2)
    |
    luvometinib (FCN-159)
    9ms
    MEK Inhibitor FCN-159 To Treat Advanced Melanoma With NRAS-aberrant (Ia) and NRAS-mutant (Ib)or NF1-mutant(1b) (clinicaltrials.gov)
    P1, N=79, Suspended, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Phase classification: P1a/1b --> P1 | N=37 --> 79 | Trial completion date: Mar 2023 --> Apr 2024 | Recruiting --> Suspended | Trial primary completion date: Sep 2022 --> Apr 2023
    Phase classification • Enrollment change • Trial completion date • Trial suspension • Trial primary completion date • Metastases
    |
    NRAS (Neuroblastoma RAS viral oncogene homolog) • NF1 (Neurofibromin 1)
    |
    NRAS mutation
    |
    luvometinib (FCN-159)
    10ms
    FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas (clinicaltrials.gov)
    P3, N=162, Recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    NF1 (Neurofibromin 1)
    |
    luvometinib (FCN-159)
    over1year
    Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov)
    P2, N=160, Active, not recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    NF1 (Neurofibromin 1)
    |
    NF1 mutation
    |
    luvometinib (FCN-159)
    over1year
    A phase II study to explore the efficacy and safety of FCN-159 in recurrent or progressive pediatric low-grade glioma (pLGG) with MAPK pathway-activated (ESMO 2023)
    FCN-159 is well tolerated and easily manageable, without new safety signal observed. Long-term efficacy and safety follow-up are ongoing.
    Clinical • P2 data
    |
    BRAF (B-raf proto-oncogene) • NF1 (Neurofibromin 1) • KIAA1549
    |
    BRAF V600E • BRAF V600 • KIAA1549-BRAF fusion • BRAF fusion
    |
    luvometinib (FCN-159)
    over1year
    Phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of FCN-159 in adults with neurofibromatosis type 1-related unresectable plexiform neurofibromas. (PubMed, BMC Med)
    FCN-159 was well tolerated up to 8 mg daily with manageable adverse events and showed promising anti-tumorigenic activity in patients with NF1-related PN, warranting further investigation in this indication.
    P1 data • PK/PD data • Journal
    |
    NF1 (Neurofibromin 1)
    |
    luvometinib (FCN-159)
    over1year
    FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas (clinicaltrials.gov)
    P3, N=162, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
    New P3 trial
    |
    NF1 (Neurofibromin 1)
    |
    luvometinib (FCN-159)
    almost2years
    Population pharmacokinetics of FCN-159, a MEK1/2 inhibitor, in adult patients with advanced melanoma and neurofibromatosis type 1 (NF1) and model informed dosing recommendations for NF1 pediatrics. (PubMed, Front Pharmacol)
    Simulations based on the final model projected daily doses of 4 mg/m QD with optimized BSA bin cutoffs would allow fixed nominal doses within each bin and result in steady state exposure approximating the adult exposure observed at the recommended phase 2 dose (RP2D) in NF1, which is 8 mg QD. The developed population PK model adequately described the PK profile of FCN-159, which was adapted using allometric scaling to inform dose selection for NF1 pediatric trials.
    PK/PD data • Journal • Metastases
    |
    NF1 (Neurofibromin 1)
    |
    luvometinib (FCN-159)
    over2years
    Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov)
    P2, N=160, Recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Not yet recruiting --> Recruiting | Initiation date: Aug 2021 --> Mar 2021 | Trial primary completion date: Nov 2024 --> Feb 2025
    Enrollment open • Trial initiation date • Trial primary completion date
    |
    NF1 (Neurofibromin 1)
    |
    NF1 mutation
    |
    luvometinib (FCN-159)
    almost3years
    FCN-159, a MEK1/2 inhibitor, in patients with advanced melanoma harboring NRAS mutations: A phase 1A dose-escalation study (AACR 2022)
    FCN-159 was well tolerated and showed antitumor activity in patients with NRAS-mutant advanced melanoma. FCN-159 12 mg QD as a treatment for NRAS-mutant advanced melanoma warrants future investigation.Table. Confirmed best overall response >Tumor response was assessed by the investigators according to Response Evaluation Criteria in Solid Tumors version 1.1.BOR, best overall response; CBR, clinical benefit rate; CR, complete response; DOR, duration of response; NA, not applicable; NE, not evaluable; NR, not reached; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
    Clinical • P1 data
    |
    NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    NRAS mutation
    |
    luvometinib (FCN-159)
    over3years
    Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov)
    P2, N=160, Not yet recruiting, Shanghai Fosun Pharmaceutical Development Co, Ltd.
    Clinical • New P2 trial
    |
    NF1 (Neurofibromin 1)
    |
    NF1 mutation
    |
    luvometinib (FCN-159)