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    DRUG:

    Nidlegy (darleukin/fibromun)

    i
    Other names: L19-IL2 + L19-TNF, L19IL2-L19TNF, L19IL2/L19TNF
    Associations

    News

    Trials
    Company:
    Philogen, Sun Pharma
    Drug class:
    T-cell stimulant, IL-2R agonist, TNF stimulant
    Related drugs:
    Associations

    News

    Trials
    2ms
    INTACT: Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients (clinicaltrials.gov)
    P2, N=162, Recruiting, Philogen S.p.A. | Active, not recruiting --> Recruiting | Initiation date: Dec 2023 --> Jul 2024
    Enrollment open • Trial initiation date • Combination therapy • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • Nidlegy (darleukin/fibromun)
    3ms
    Neoadjuvant L19IL2/L19TNF- Pivotal Study (clinicaltrials.gov)
    P3, N=214, Active, not recruiting, Philogen S.p.A. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2028
    Enrollment closed • Trial completion date • Surgery
    |
    BRAF (B-raf proto-oncogene)
    |
    Nidlegy (darleukin/fibromun)
    9ms
    Neoadjuvant L19IL2/L19TNF- Pivotal Study (clinicaltrials.gov)
    P3, N=214, Recruiting, Philogen S.p.A. | Trial primary completion date: Dec 2023 --> Oct 2024
    Trial primary completion date • Surgery
    |
    BRAF (B-raf proto-oncogene)
    |
    Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
    10ms
    INTACT/MeRCI: Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients (clinicaltrials.gov)
    P2, N=162, Active, not recruiting, Philogen S.p.A.
    New P2 trial
    |
    Keytruda (pembrolizumab) • Nidlegy (darleukin/fibromun)
    1year
    DUNCAN: Intratumoral Administration of Daromun in Non-melanoma Skin Cancer Patients (clinicaltrials.gov)
    P2, N=40, Recruiting, Philogen S.p.A. | Trial completion date: Feb 2023 --> Sep 2024 | Trial primary completion date: Nov 2022 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    Nidlegy (darleukin/fibromun)
    over1year
    KEYNOTE PRESENTATION: Antibody-Cytokine Fusions for the Treatment of Difficult-to-Cure Cancer Types: Emerging Clinical Results (PEGS 2023)
    In addition, results from clinical trials with Nidlegy in high-risk basal cell carcinoma patients, candidates for disfiguring surgery who experienced durable complete responses, will be shared. Other clinical trial results in “difficult-to-treat tumors” will be discussed.
    Clinical
    |
    Nidlegy (darleukin/fibromun)
    over2years
    Neoadjuvant L19IL2/L19TNF- Pivotal Study (clinicaltrials.gov)
    P3, N=214, Recruiting, Philogen S.p.A. | Trial primary completion date: Dec 2018 --> Dec 2023
    Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
    over3years
    Current status of intralesional agents in treatment of malignant melanoma. (PubMed, Ann Transl Med)
    This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.
    Review • Journal
    |
    TYRP1 (Tyrosinase Related Protein 1) • CD40 (CD40 Molecule) • MAGEA3 (MAGE Family Member A3)
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • Imlygic (talimogene laherparepvec) • bempegaldesleukin (NKTR-214) • vidutolimod (CMP-001) • Fibromun (onfekafusp alfa) • ONCOS-102 • cavrotolimod (AST-008) • cisplatin/vinblastine/SHAO-FA (INT230-6) • nelitolimod (SD-101) • ADU-S100 • CV8102 • Cavatak (gebasaxturev) • Hiltonol (poly-ICLC) • LHC165 • NKTR-262 • Nidlegy (darleukin/fibromun) • OrienX010 • Telomelysin (suratadenoturev) • canerpaturev (TBI-1401) • giloralimab (ABBV-927) • lefitolimod (MGN1703) • sotigalimab (PYX-107) • tilsotolimod (IMO-2125) • ulevostinag (MK-1454)