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    DRUG:

    Niktimvo (axatilimab-csfr)

    i
    Other names: SNDX-6352, UCB 6352, UCB6352, SNDX 6352, INCA34176, INCA034176, INCA-034176, SNDX6352, UCB-6352
    Associations

    News

    Trials
    Company:
    Incyte, Knight Therap, Royalty, Syndax Pharma, UCB
    Drug class:
    CSF-1R inhibitor
    Related drugs:
    Associations

    News

    Trials
    2d
    ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation (clinicaltrials.gov)
    P2, N=34, Not yet recruiting, Stephen Shiao | Trial completion date: Dec 2032 --> Jul 2033 | Initiation date: Sep 2025 --> Jun 2026 | Trial primary completion date: Dec 2032 --> Jul 2033
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
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    Keytruda (pembrolizumab) • Niktimvo (axatilimab-csfr)
    2d
    Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation (clinicaltrials.gov)
    P2, N=35, Recruiting, Stephen Shiao | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Niktimvo (axatilimab-csfr)
    6d
    Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial (clinicaltrials.gov)
    P2, N=72, Not yet recruiting, Mayo Clinic | Trial completion date: Jan 2033 --> Jun 2033 | Initiation date: Jan 2026 --> Jun 2026 | Trial primary completion date: Jan 2028 --> Jun 2028
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    cyclophosphamide • Niktimvo (axatilimab-csfr)
    14d
    INCA34176-254: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P2, N=120, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Jakafi (ruxolitinib) • prednisone • Niktimvo (axatilimab-csfr)
    16d
    Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Northside Hospital, Inc.
    New P1 trial
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 deletion
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    Venclexta (venetoclax) • decitabine • Niktimvo (axatilimab-csfr)
    26d
    SNDX-6352-0506: MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=145, Active, not recruiting, Syndax Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Niktimvo (axatilimab-csfr)
    1m
    AGAVE-201: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov)
    P2, N=241, Active, not recruiting, Syndax Pharmaceuticals | Trial completion date: Dec 2027 --> Sep 2027
    Trial completion date
    |
    CSF1 (Colony stimulating factor 1)
    |
    Niktimvo (axatilimab-csfr)
    1m
    OSU-23442: Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia (clinicaltrials.gov)
    P1/2, N=52, Recruiting, Uma Borate | Trial completion date: Dec 2026 --> Oct 2028 | Trial primary completion date: Dec 2025 --> Oct 2027
    Trial completion date • Trial primary completion date
    |
    SF3B1 (Splicing Factor 3b Subunit 1)
    |
    SF3B1 mutation
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    azacitidine • Niktimvo (axatilimab-csfr)
    2ms
    CSF-1R inhibition and lenalidomide synergize to promote myeloma control after autologous stem cell transplantation. (PubMed, Blood)
    CSF-1R blockade depleted these immunosuppressive macrophages, which correlated with decreased expression of inhibitory receptors and enhanced expression of activation markers in Tphex. Given the FDA approval of axatilimab for chronic GVHD, combining CSF-1R blockade with lenalidomide maintenance represents a readily testable strategy to improve progression-free survival after ASCT.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • PVR (PVR Cell Adhesion Molecule) • KLRC1 (Killer Cell Lectin Like Receptor C1) • KLRD1 (Killer Cell Lectin Like Receptor D1)
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    PD-L1 expression
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    lenalidomide • Niktimvo (axatilimab-csfr)
    2ms
    INCA034176-256: A Phase 2, Randomized, Open-Label Study Of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (2025-521849-25-00)
    P1/2, N=42, Not yet recruiting, Incyte Corp.
    New P1/2 trial
    |
    Niktimvo (axatilimab-csfr)
    3ms
    Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial (clinicaltrials.gov)
    P2, N=72, Not yet recruiting, Mayo Clinic
    New P2 trial
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    cyclophosphamide • Niktimvo (axatilimab-csfr)
    4ms
    Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML) (clinicaltrials.gov)
    P1/2, N=66, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Jakafi (ruxolitinib) • Niktimvo (axatilimab-csfr)