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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
    11d
    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)
    14d
    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
    |
    azacitidine • Niktimvo (axatilimab-csfr)
    26d
    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)
    |
    PD-L1 expression
    |
    lenalidomide • Niktimvo (axatilimab-csfr)
    1m
    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)
    2ms
    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)
    3ms
    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)
    4ms
    A Study to Evaluate 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) (clinicaltrials.gov)
    P2, N=60, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • imatinib • everolimus • cyclosporine • Niktimvo (axatilimab-csfr)
    5ms
    A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P1, N=24, Recruiting, M.D. Anderson Cancer Center | Phase classification: P1/2 --> P1 | Not yet recruiting --> Recruiting
    Enrollment open • Phase classification
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Niktimvo (axatilimab-csfr)
    7ms
    INCA034176-355: A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (clinicaltrials.gov)
    P3, N=9, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=300 --> 9
    Enrollment closed • Enrollment change
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • imatinib • everolimus • pentostatin • cyclosporine • Niktimvo (axatilimab-csfr)
    7ms
    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: Sep 2027 --> Dec 2027
    Trial completion date
    |
    CSF1 (Colony stimulating factor 1)
    |
    Niktimvo (axatilimab-csfr)
    7ms
    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, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    Jakafi (ruxolitinib) • Niktimvo (axatilimab-csfr)
    7ms
    A Study to Evaluate 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) (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Incyte Corporation
    New P2 trial
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • imatinib • everolimus • cyclosporine • Niktimvo (axatilimab-csfr)