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Niktimvo (axatilimab-csfr)
i
Other names: SNDX-6352, UCB 6352, UCB6352, SNDX 6352, INCA34176, INCA034176, INCA-034176, SNDX6352, UCB-6352
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Company:
Incyte, Knight Therap, Royalty, Syndax Pharma, UCB
Drug class:
CSF-1R inhibitor
Related drugs:
5d
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
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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)
17d
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
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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
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UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
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cyclophosphamide • Niktimvo (axatilimab-csfr)
2ms
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
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Jakafi (ruxolitinib) • Niktimvo (axatilimab-csfr)
3ms
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
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Imbruvica (ibrutinib) • Rituxan (rituximab) • imatinib • everolimus • cyclosporine • Niktimvo (axatilimab-csfr)
4ms
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)
6ms
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
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Imbruvica (ibrutinib) • Rituxan (rituximab) • imatinib • everolimus • pentostatin • cyclosporine • Niktimvo (axatilimab-csfr)
6ms
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)
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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
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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
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Imbruvica (ibrutinib) • Rituxan (rituximab) • imatinib • everolimus • cyclosporine • Niktimvo (axatilimab-csfr)
7ms
Axatilimab for Sclerotic Chronic Graft-versus-Host Disease (clinicaltrials.gov)
P2, N=50, Recruiting, Fred Hutchinson Cancer Center | Not yet recruiting --> Recruiting
Enrollment open
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Niktimvo (axatilimab-csfr)
7ms
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)
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