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- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Axatilimab for Patients With Dermatologic Manifestations of Chronic Graft-Versus-Host Disease: A Post Hoc Analysis () - Feb 26, 2025 - Abstract #AAD2025AAD_3441;
P1/2, P2
These results support the clinical activity and symptom improvement with axatilimab in the skin, mouth, and joints/fascia among patients with long-standing cGVHD, including difficult-to-treat, severe sclerotic skin disease. These findings corroborate results from a prior phase 1/2 study (NCT03604692).
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
New P1/2 trial, Monotherapy: A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD (clinicaltrials.gov) - Feb 26, 2025
P1/2, N=30, Not yet recruiting, Sponsor: Incyte Corporation
- || Review, Journal: Treatment Response in Individual Organs Affected by Chronic Graft-Versus-Host Disease. (Pubmed Central) - Feb 25, 2025
For cutaneous sclerosis, we observed large discrepancies in organ response rates according to the current NIH criteria and patient-reported improvement, highlighting the need for better measurement tools. High response rates for lung involvement with certain novel drugs deserve further investigation.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Axatilimab in Patients With Lung Chronic Graft-versus-Host Disease and Related Bronchiolitis Obliterans Syndrome: Results From the AGAVE-201 Study (MS07) - Feb 24, 2025 - Abstract #ATS2025ATS_5541;
- ||||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Trial suspension: 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) - Feb 24, 2025
P1/2, N=52, Suspended, Sponsor: Uma Borate
High response rates for lung involvement with certain novel drugs deserve further investigation. Recruiting --> Suspended
- | FDA event, Journal: FDA-approved therapies for chronic GVHD. (Pubmed Central) - Feb 20, 2025
In the last ten years, the drugs ibrutinib, ruxolitinib, belumosudil and axatilimab were FDA-approved for cGVHD. Here we discuss which signaling pathways and cell types are targeted, the clinical studies that were the basis for FDA-approval, and future directions for clinical research.
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
PK/PD data, Journal: Semimechanistic Population PK/PD Modeling of Axatilimab in Healthy Participants and Patients With Solid Tumors or Chronic Graft-Versus-Host Disease. (Pubmed Central) - Feb 18, 2025
Among the 11 statistically significant covariates, one (body weight) and two (participant population type and baseline CPK) covariates affected axatilimab steady-state exposure and steady-state NCMC levels by >?20%, respectively. These results informed the axatilimab dosing strategy in patients with cGVHD.
- |||||||||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
New P3 trial: 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) - Feb 12, 2025
P3, N=300, Not yet recruiting, Sponsor: Incyte Corporation
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
PHENOTYPIC CHANGES IN SYSTEMIC IMMUNE CELLS IN RESPONSE TO AXATILIMAB IN HEALTHY MALE JAPANESE VOLUNTEERS (Firenze (S1)) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2253;
Changes in cell surface markers expressed on NCMs suggest that subpopulations of NCMs may represent newly generated monocyte progenitors and/or may represent existing NCMs with differential responses to axatilimab treatment. Further investigation regarding the effects of axatilimab on NCMs in patients with cGVHD is warranted.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
PHENOTYPIC CHANGES IN SYSTEMIC IMMUNE CELLS IN RESPONSE TO AXATILIMAB IN HEALTHY MALE JAPANESE VOLUNTEERS (ePoster Area) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2252;
Changes in cell surface markers expressed on NCMs suggest that subpopulations of NCMs may represent newly generated monocyte progenitors and/or may represent existing NCMs with differential responses to axatilimab treatment. Further investigation regarding the effects of axatilimab on NCMs in patients with cGVHD is warranted.
- REAL-WORLD TREATMENT PATTERNS OF PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE WHO RECEIVED 3 OR MORE LINES OF TREATMENT IN THE UNITED STATES (Firenze (S1)) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2237;
Ruxolitinib was the most common agent used across treatment lines, suggesting its clinical benefit in early settings as well as for salvage therapy after failure of multiple lines of treatment. Combination treatment in later lines of cGVHD were common, suggesting the need to consider cGVHD mechanistic biology and tailoring therapies with nonoverlapping mechanisms of action when considering therapeutic strategy in patients with cGVHD.
- REAL-WORLD TREATMENT PATTERNS OF PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE WHO RECEIVED 3 OR MORE LINES OF TREATMENT IN THE UNITED STATES (ePoster Area) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2236;
Ruxolitinib was the most common agent used across treatment lines, suggesting its clinical benefit in early settings as well as for salvage therapy after failure of multiple lines of treatment. Combination treatment in later lines of cGVHD were common, suggesting the need to consider cGVHD mechanistic biology and tailoring therapies with nonoverlapping mechanisms of action when considering therapeutic strategy in patients with cGVHD.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
DYNAMICS OF OVERALL AND ORGAN-SPECIFIC RESPONSES TO AXATILIMAB IN CHRONIC GRAFT-VERSUS-HOST DISEASE: ANALYSIS FROM THE AGAVE-201 STUDY (Firenze (S1)) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2169;
P2
By D56, more than half of responders had clinical responses and reported symptom improvement. Lower and upper gastrointestinal tracts, esophagus, liver, and joints/fascia were fastest to respond, whereas lung, mouth, eye, and skin responses were slower.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
DYNAMICS OF OVERALL AND ORGAN-SPECIFIC RESPONSES TO AXATILIMAB IN CHRONIC GRAFT-VERSUS-HOST DISEASE: ANALYSIS FROM THE AGAVE-201 STUDY (ePoster Area) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2168;
P2
By D56, more than half of responders had clinical responses and reported symptom improvement. Lower and upper gastrointestinal tracts, esophagus, liver, and joints/fascia were fastest to respond, whereas lung, mouth, eye, and skin responses were slower.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
THE EFFECTS OF PRIOR LINES OF THERAPY ON CLINICAL OUTCOMES FOR PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE RECEIVING AXATILIMAB: A POST HOC ANALYSIS OF AGAVE-201 (Firenze (S1)) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2167;
P2
Patients who received axatilimab immediately after a regimen with ruxolitinib demonstrated rapid, durable clinical responses. Organ-specific responses to axatilimab were noted regardless of last prior therapy, and there is a trend toward higher response rates for those treated in their last LOT with ruxolitinib compared with belumosudil in some organs (joints/fascia, mouth, lungs, eyes, and skin).
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
THE EFFECTS OF PRIOR LINES OF THERAPY ON CLINICAL OUTCOMES FOR PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE RECEIVING AXATILIMAB: A POST HOC ANALYSIS OF AGAVE-201 (ePoster Area) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2166;
P2
Patients who received axatilimab immediately after a regimen with ruxolitinib demonstrated rapid, durable clinical responses. Organ-specific responses to axatilimab were noted regardless of last prior therapy, and there is a trend toward higher response rates for those treated in their last LOT with ruxolitinib compared with belumosudil in some organs (joints/fascia, mouth, lungs, eyes, and skin).
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
CORRELATIONS OF CLINICIAN-REPORTED RESPONSES WITH OTHER RESPONSE MEASURES IN PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE: AN ANALYSIS FROM THE AGAVE-201 TRIAL (Firenze (S1)) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2159;
P2
These data provide insights into the clinical benefit achieved with axatilimab and suggest that additional exploration of secondary endpoints is warranted for cGVHD therapies. Clinical Trial Registry: NCT04710576
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
CORRELATIONS OF CLINICIAN-REPORTED RESPONSES WITH OTHER RESPONSE MEASURES IN PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE: AN ANALYSIS FROM THE AGAVE-201 TRIAL (ePoster Area) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2158;
P2
These data provide insights into the clinical benefit achieved with axatilimab and suggest that additional exploration of secondary endpoints is warranted for cGVHD therapies. Clinical Trial Registry: NCT04710576
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
AXATILIMAB ABROGATES INFLAMMATORY CYTOKINES AND CHEMOKINES AND INTERRUPTS THE DIFFERENTIATION OF MONOCYTES TO MACROPHAGES, A PATHOGENIC DRIVER OF INFLAMMATION AND FIBROSIS IN CGVHD (ePoster Area) - Feb 5, 2025 - Abstract #EBMT2025EBMT_2145;
P2
Clinical Trial Registry: NCT04710576 Together, these data suggest that blocking CSF-1/CSF-1R signaling by axatilimab reduces proinflammatory signaling in monocytes and monocyte-derived macrophages and specifically reduces the number of monocytes in the peripheral blood of human CSF-1R knock-in mice.
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment closed, Monotherapy: INCA34176-358: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - Feb 5, 2025
P3, N=21, Active, not recruiting, Sponsor: Incyte Biosciences Japan GK
Together, these data suggest that blocking CSF-1/CSF-1R signaling by axatilimab reduces proinflammatory signaling in monocytes and monocyte-derived macrophages and specifically reduces the number of monocytes in the peripheral blood of human CSF-1R knock-in mice. Recruiting --> Active, not recruiting
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Review, Journal: Axatilimab. (Pubmed Central) - Jan 13, 2025
Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.
- ||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment open: A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants (clinicaltrials.gov) - Jan 3, 2025
P1, N=72, Recruiting, Sponsor: Incyte Corporation
For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. Not yet recruiting --> Recruiting
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte, Opdivo (nivolumab) / BMS
Enrollment open: NAHL: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov) - Dec 26, 2024
P2, N=9, Recruiting, Sponsor: University of Utah
Not yet recruiting --> Recruiting Suspended --> Recruiting
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Kinetics and Management of Hepatic Laboratory Elevations Associated with Axatilimab in the Agave-201 Study (HCC Exhibit Hall 3; In-Person) - Dec 19, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_1107;
P2
Laboratory-based TEAEs during AXA treatment were mostly transient, grade 1/2, required few dose changes, and did not result in treatment discontinuation. Altogether, these results indicate that the effects of AXA on liver function were minimal.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
The Effects of Prior Lines of Therapy on Clinical Outcomes for Patients with Chronic Graft-Versus-Host Disease Receiving Axatilimab: A Post Hoc Analysis of Agave-201 (HCC Exhibit Hall 3; In-Person) - Dec 19, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_1095;
P2
Small patient numbers and mixed treatment regimens may limit interpretation. These data demonstrate the efficacy of AXA for steroid-refractory cGVHD after 2 LOT, including patients treated with RUX as last LOT.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Incyte, Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Axatilimab Combination Therapies with Ruxolitinib and/or Belumosudil Induces Clinical Responses in Patients with Severe, Treatment-Refractory Chronic Gvhd (HCC 313 ABC; In-Person) - Dec 19, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_755;
All pts had severe cGVHD, notably 5 pts had severe sclerodermatous involvement and 1 severe BOS. All pts progressed through RUX and BEL as monotherapies, and 4/8 progressed through combo RUX/BEL prior to AXA.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Axatilimab (HCC Ballroom C; In-Person) - Dec 12, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_636;
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Real-World Clinical Outcomes of Severe, Treatment-Refractory Chronic Gvhd Patients Treated with Axatilimab Combination Therapies () - Dec 7, 2024 - Abstract #ASH2024ASH_9389;
Patients tolerated combination axa with rux and/or bel with 4/8 patients receiving rux-bel-axa. This is the first report of the combination of axa with rux and/or bel, demonstrating that a combination approach with CSF1R/JAK2/ROCK2 inhibition is feasible, tolerable, and may yield clinical benefit in highly refractory cases of cGVHD with fibrotic manifestations.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Efficacy of Axatilimab in the Management of Chronic Graft-Versus-Host Disease () - Dec 7, 2024 - Abstract #ASH2024ASH_9388;
This is the first report of the combination of axa with rux and/or bel, demonstrating that a combination approach with CSF1R/JAK2/ROCK2 inhibition is feasible, tolerable, and may yield clinical benefit in highly refractory cases of cGVHD with fibrotic manifestations. The pooled incidence of drug discontinuation due to treatment-related adverse events was 16% (95% CI : 0.12-0.20, I
- Jakafi (ruxolitinib) / Incyte
Ruxolitinib Resistance or Intolerance in Steroid-Refractory Chronic Graft-Versus-Host Disease - a Real-World Single Center Analysis () - Dec 7, 2024 - Abstract #ASH2024ASH_9373;
AML was the most common transplant indication (n = 24), 68% patients underwent marrow ablative conditioning and 96% (n = 45) patients received tacrolimus and methotrexate for GVHD prophylaxis...After ruxolitinib failure/intolerance, the three most common next line agents used were belumsoudil (51%), ECP (30%) and on trial axatilimab (4.5%)...Median duration on ECP was 466.5 (95% CI : [167, Not reached]) days.11 (25.6%) patients continued ruxolitinib while initiating 3rd line therapy of which 6 were concurrently on ECP (ORR 67%, 1 CR, 3 PR, 1 Stable disease [SD], 1 PD) while 3 were on belumosudil (ORR 67%, 2 PR, 1 SD).Conclusion : cGVHD remains a significant problem, with patients requiring therapy after ruxolitinib. Third line therapy provides modest benefit with responses in 38.5% of patients, creating potential for new drug development or utilizing current drugs as combinations for improved outcomes.
- |||||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment open: A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - Dec 4, 2024
P3, N=240, Recruiting, Sponsor: Incyte Corporation
Third line therapy provides modest benefit with responses in 38.5% of patients, creating potential for new drug development or utilizing current drugs as combinations for improved outcomes. Not yet recruiting --> Recruiting
- ||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
New P1 trial: A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants (clinicaltrials.gov) - Dec 3, 2024
P1, N=72, Not yet recruiting, Sponsor: Incyte Corporation
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Review, Journal: Axatilimab: First Approval. (Pubmed Central) - Nov 28, 2024
Axatilimab was added to the NCCN guidelines for cGVHD in August 2024. This article summarizes the development milestones leading to this first approval of axatilimab for the treatment of cGVHD.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Axatilimab Abrogates Inflammatory Cytokines and Chemokines and Interrupts the Differentiation of Monocytes to Macrophages, a Pathogenic Driver of Inflammation and Fibrosis in cGVHD (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_4405;
P1/2, P2
Conclusions : Taken together, these data suggest that blocking CSF-1/CSF-1R signaling by axatilimab reduces proinflammatory signaling in monocytes and monocyte-derived macrophages and specifically reduces the number of monocytes and macrophages in the peripheral blood and peritoneal lavages of human CSF-1R knock-in mice. These data support the observation from clinical studies (phase 1/2 and pivotal AGAVE-201 study) that nonclassical monocytes were depleted in patients with cGVHD treated with axatilimab.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Incyte, Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Identification of High-Risk Patients and Establishment of a Clinical Prediction Model for Frontline Steroid Failure in Chronic Graft-Versus-Host-Disease (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3247;
Conclusion : Unrelated donor use, severe acute/chronic GvHD and ?2 involved organs are high risk characteristics for frontline steroid failure. Future research should assess interventions including incorporation of newer agents such as ruxolitinib, belumosudil or axatilimab in addition to corticosteroids in these high-risk patients.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Exposure-Response Relationships for Axatilimab, a Humanized Monoclonal Antibody Targeting CSF-1R, in Patients with Chronic Graft-Versus-Host Disease (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3198;
P1/2, P2
In forward simulations evaluating the effect of body weight on the axatilimab 0.3 mg/kg Q2W regimen across 2 efficacy and 10 safety endpoints, the maximum differences in median predicted probabilities between the 10th and 90th percentiles of with body weight were <1.4% and <1.7% for efficacy and safety, respectively. Conclusions : These results support the 0.3 mg/kg Q2W regimen of axatilimab in patients with cGVHD.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Dynamics of Overall and Organ-Specific Responses to Axatilimab in Chronic Graft-Versus-Host Disease: Analysis from the Agave-201 Study (Ballroom 20CD (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_1459;
P2
Conclusions : These results support the 0.3 mg/kg Q2W regimen of axatilimab in patients with cGVHD. Patients received a median of 4 prior therapy lines (range, 2
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte, Zynyz (retifanlimab-dlwr) / Incyte
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 (NEW START) (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_981;
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte, Opdivo (nivolumab) / BMS
TRIAL IN PROGRESS: EVALUATING COMBINATION OF NIVOLUMAB AND AXATILIMAB IN PATIENTS WITH RELAPSED/REFRACTORY CLASSICAL HODGKIN LYMPHOMA (NAHL) (Gro) - Oct 31, 2024 - Abstract #ISHL2024ISHL_88;
P2
Key secondary endpoints include frequency of AEs and serious adverse events (SAEs), PFS and ORR as measured by LYRIC criteria. Exploratory endpoints include: (i) pre-treatment and on-treatment lymph node biopsy to examine changes in tumor microenvironment, (ii) serial blood analysis including cytokine profile, circulating tumor DNA testing, and flow cytometry.
- ||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment open: 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) - Oct 30, 2024
P1/2, N=52, Recruiting, Sponsor: Uma Borate
Exploratory endpoints include: (i) pre-treatment and on-treatment lymph node biopsy to examine changes in tumor microenvironment, (ii) serial blood analysis including cytokine profile, circulating tumor DNA testing, and flow cytometry. Not yet recruiting --> Recruiting
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
New P2 trial, Combination therapy: Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease (clinicaltrials.gov) - Oct 28, 2024
P2, N=49, Not yet recruiting, Sponsor: University of Miami
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte, Opdivo (nivolumab) / BMS
Trial suspension: NAHL: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov) - Oct 28, 2024
P2, N=9, Suspended, Sponsor: University of Utah
Not yet recruiting --> Recruiting Recruiting --> Suspended
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Trial completion date: AGAVE-201: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov) - Oct 9, 2024
P2, N=241, Active, not recruiting, Sponsor: Syndax Pharmaceuticals
Recruiting --> Suspended Trial completion date: Dec 2024 --> Sep 2027
- || Review, Journal: Current Approaches for the Prevention and Treatment of Acute and Chronic GVHD. (Pubmed Central) - Sep 27, 2024
Bronchiolitis obliterans syndrome (BOS) still represents a challenge; among the compounds targeting non-immune effectors, Alvelestat, a Neutrophil elastase inhibitor, seems promising in BOS. Finally, in both aGVHD and cGVHD, the association of biological markers with specific disease manifestations could help refine risk stratification and the availability of reliable biomarkers for specific treatments.
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
CSF-1R Inhibitor (Axatilimab) for Chronic GVHD (Room B (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_186;
Responses were not influenced by the extent of cGVHD involvement at baseline organ, number of received prior lines of treatment (including use of ruxolitinib, ibrutinib or belumosudil), and were seen across all organs, including sclerotic manifestation such as joints and fascia, esophagus, lung, and skin. Targeting CSF-1R
- ||| Jakafi (ruxolitinib) / Incyte, Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment open: 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) - Sep 23, 2024
P2, N=120, Recruiting, Sponsor: Incyte Corporation
Targeting CSF-1R Not yet recruiting --> Recruiting
- |||||||||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
New P3 trial: A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - Sep 19, 2024
P3, N=240, Not yet recruiting, Sponsor: Incyte Corporation
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Efficacy of Axatilimab in the Management of Refractory Chronic Graft-Versus-Host Disease (LEVEL 3, HALL B3) - Aug 30, 2024 - Abstract #SOHO2024SOHO_967;
In this systematic review, axatilimab exhibits promising therapeutic outcomes for refractory cGVHD and an acceptable safety profile based on the findings from phase 1 and phase 2 clinical trials. However, prospective clinical trials with randomization are needed to consolidate these findings.
- | Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Trial initiation date: Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer (clinicaltrials.gov) - Aug 30, 2024
P1, N=20, Recruiting, Sponsor: Dana-Farber Cancer Institute
However, prospective clinical trials with randomization are needed to consolidate these findings. Initiation date: Aug 2025 --> Aug 2024
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Enrollment open: Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer (clinicaltrials.gov) - Aug 22, 2024
P1, N=20, Recruiting, Sponsor: Dana-Farber Cancer Institute
Initiation date: Aug 2025 --> Aug 2024 Not yet recruiting --> Recruiting