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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
    24d
    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
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    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Niktimvo (axatilimab-csfr)
    3ms
    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 • Niktimvo (axatilimab-csfr)
    3ms
    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
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    CSF1 (Colony stimulating factor 1)
    |
    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, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
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    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, Not yet recruiting, Incyte Corporation
    New P2 trial
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • imatinib • everolimus • Niktimvo (axatilimab-csfr)
    4ms
    Axatilimab for Sclerotic Chronic Graft-versus-Host Disease (clinicaltrials.gov)
    P2, N=50, Recruiting, Fred Hutchinson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Niktimvo (axatilimab-csfr)
    4ms
    JAK2 Inhibitors and Emerging Therapies in Graft-Versus-Host Disease: Current Perspectives and Future Directions. (PubMed, Biomedicines)
    The introduction of ruxolitinib, a selective JAK1/2 inhibitor, has transformed the treatment landscape for steroid-refractory acute and chronic GVHD, leading to improved response rates and durable symptom control...In 2024, the FDA approved axatilimab, a CSF-1R inhibitor that targets monocyte-derived macrophages in fibrotic chronic GVHD, and remestemcel-L, an allogeneic mesenchymal stromal cell therapy, for pediatric steroid-refractory acute GVHD...The integration of these tools with organ-specific and personalized approaches marks a shift toward more precise, durable, and tolerable GVHD therapy. This review highlights the current state and future direction of JAK2 inhibition and complementary therapies in the evolving GVHD treatment paradigm.
    Review • Journal
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    IFNG (Interferon, gamma) • IL6 (Interleukin 6)
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    Jakafi (ruxolitinib) • Niktimvo (axatilimab-csfr)
    5ms
    INCA034176-102: A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants (clinicaltrials.gov)
    P1, N=72, Completed, Incyte Corporation | Recruiting --> Completed
    Trial completion
    |
    Niktimvo (axatilimab-csfr)
    6ms
    Axatilimab for Sclerotic Chronic Graft-versus-Host Disease (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Fred Hutchinson Cancer Center
    New P2 trial
    |
    Niktimvo (axatilimab-csfr)
    6ms
    A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory Active Chronic Graft Versus Host Disease After Systemic Therapy (ChiCTR2500101465)
    P1/2, N=30, Not yet recruiting, Peking University People's Hospital; Peking University People's Hospital
    New P1/2 trial
    |
    Niktimvo (axatilimab-csfr)
    7ms
    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=300, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • imatinib • everolimus • pentostatin • Niktimvo (axatilimab-csfr)
    7ms
    Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease (clinicaltrials.gov)
    P2, N=49, Recruiting, University of Miami | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Niktimvo (axatilimab-csfr)