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    DRUG:

    itacitinib (INCB039110)

    i
    Other names: INCB039110, INCB-039110, INCB 39110, INCB39110, INCB-39110, INCB 039110, IBI-377, IBI377, IBI 377
    Company:
    Incyte, Innovent Biologics
    Drug class:
    JAK1 inhibitor
    Related drugs:
    9d
    Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
    P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
    |
    Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
    30d
    Itacitinib for Prevention of Graft-Versus-Host Disease and Cytokine Release Syndrome in Haploidentical Transplantation. (PubMed, Blood)
    Although post-transplant cyclophosphamide (PtCy) has improved graft vs. host disease (GvHD) prophylaxis in haplo-HCT, patients continue to experience life-threatening complications. Itacitinib, when added to standard GvHD prophylaxis, was well tolerated and resulted in low rates of CRS, acute and chronic GvHD, NRM and encouraging rates of GvHD-free relapse-free survival (GRFS) and OS after haplo-HCT. NCT03755414.
    Journal
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • JAK1 (Janus Kinase 1)
    |
    cyclophosphamide • itacitinib (INCB039110)
    1m
    Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=23, Active, not recruiting, University of Pennsylvania | Trial primary completion date: Oct 2024 --> May 2024
    Trial primary completion date
    |
    everolimus • itacitinib (INCB039110)
    2ms
    Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov)
    P2, N=112, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=200 --> 112
    Enrollment closed • Enrollment change
    |
    Imbruvica (ibrutinib) • Jakafi (ruxolitinib) • parsaclisib (INCB50465) • itacitinib (INCB039110)
    2ms
    Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2, N=0, Withdrawn, Douglas Johnson | N=25 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Apr 2026 --> Sep 2026
    Enrollment change • Trial withdrawal • Trial primary completion date • Adverse events • Checkpoint inhibition
    |
    itacitinib (INCB039110)
    2ms
    Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov)
    P2, N=200, Recruiting, Incyte Corporation | Trial completion date: Sep 2024 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2027
    Trial completion date • Trial primary completion date
    |
    Imbruvica (ibrutinib) • Jakafi (ruxolitinib) • parsaclisib (INCB50465) • itacitinib (INCB039110)
    2ms
    Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov)
    P1, N=121, Active, not recruiting, Incyte Corporation | Trial completion date: Aug 2024 --> Jan 2025 | Trial primary completion date: Aug 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    itacitinib (INCB039110) • dezapelisib (INCB040093)
    2ms
    Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant (clinicaltrials.gov)
    P1, N=8, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
    Trial completion date • Trial primary completion date
    |
    itacitinib (INCB039110)
    3ms
    NCI-2019-03203: Itacitinib and Alemtuzumab in Treating Patients with T-Cell Prolymphocytic Leukemia (clinicaltrials.gov)
    P1, N=15, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Sep 2024 | Trial primary completion date: Dec 2026 --> Sep 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    Campath (alemtuzumab) • itacitinib (INCB039110)
    4ms
    Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
    P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2026 --> Dec 2025
    Trial completion date • CAR T-Cell Therapy
    |
    JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
    |
    Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
    5ms
    NCI-2022-03765: Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants (clinicaltrials.gov)
    P2, N=50, Recruiting, City of Hope Medical Center | Trial completion date: Apr 2024 --> May 2026 | Trial primary completion date: Apr 2024 --> May 2026
    Trial completion date • Trial primary completion date • Post-transplantation
    |
    cyclophosphamide • itacitinib (INCB039110)
    6ms
    haplo-HCT: Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation (clinicaltrials.gov)
    P1, N=55, Completed, Washington University School of Medicine | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> May 2024
    Trial completion • Trial completion date
    |
    CD34 (CD34 molecule)
    |
    itacitinib (INCB039110)
    6ms
    Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, City of Hope Medical Center | Phase classification: P2a --> P2 | Trial completion date: May 2024 --> Dec 2024
    Phase classification • Trial completion date
    |
    sirolimus • melphalan • fludarabine IV • itacitinib (INCB039110)
    6ms
    Combined JAK inhibition and PD-1 immunotherapy for non-small cell lung cancer patients. (PubMed, Science)
    Patients with persistent inflammation refractory to itacitinib showed progressive CD8 T cell terminal differentiation and progressive disease. Thus, JAK inhibition may improve the efficacy of anti-PD-1 immunotherapy by pivoting T cell differentiation dynamics.
    Clinical Trial,Phase II • Journal
    |
    CD8 (cluster of differentiation 8) • JAK1 (Janus Kinase 1)
    |
    itacitinib (INCB039110)
    7ms
    Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
    P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: May 2026 --> Nov 2026 | Trial primary completion date: Jun 2024 --> Oct 2024
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
    |
    Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
    7ms
    Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2, N=25, Recruiting, Douglas Johnson | Trial completion date: Dec 2026 --> Apr 2027 | Trial primary completion date: Dec 2025 --> Apr 2026
    Trial completion date • Trial primary completion date • Adverse events • Checkpoint inhibition
    |
    itacitinib (INCB039110)
    8ms
    NCI-2019-03203: Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Campath (alemtuzumab) • itacitinib (INCB039110)
    8ms
    NCI-2018-00615: Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas (clinicaltrials.gov)
    P1, N=27, Terminated, Fred Hutchinson Cancer Center | Active, not recruiting --> Terminated; The study was terminated early with 27 out of 28 planned subjects enrolled. This decision was multifactorial, including slow enrollment in the last remaining cohort and a lack of evidence of clinical benefit.
    Trial termination • Metastases
    |
    CD163 (CD163 Molecule) • ITGAM (Integrin, alpha M)
    |
    itacitinib (INCB039110)
    8ms
    Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant (clinicaltrials.gov)
    P1, N=8, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=15 --> 8
    Enrollment closed • Enrollment change
    |
    itacitinib (INCB039110)
    9ms
    Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cyclophosphamide • fludarabine IV • thiotepa • busulfan • itacitinib (INCB039110)
    9ms
    Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov)
    P1, N=121, Active, not recruiting, Incyte Corporation | Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    itacitinib (INCB039110) • dezapelisib (INCB040093)
    9ms
    Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov)
    P1, N=31, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • thiotepa • busulfan • itacitinib (INCB039110)
    9ms
    Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients (clinicaltrials.gov)
    P1, N=32, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase classification: P1a/1b --> P1
    Phase classification • Post-transplantation
    |
    cyclophosphamide • itacitinib (INCB039110)
    10ms
    haplo-HCT: Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation (clinicaltrials.gov)
    P1, N=55, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD34 (CD34 molecule)
    |
    itacitinib (INCB039110)
    10ms
    haplo-HCT: Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation (clinicaltrials.gov)
    P1, N=55, Recruiting, Washington University School of Medicine | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Feb 2024 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    itacitinib (INCB039110)
    10ms
    Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2027 --> Apr 2025 | Trial primary completion date: Feb 2027 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    cyclophosphamide • fludarabine IV • thiotepa • busulfan • itacitinib (INCB039110)
    10ms
    Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=23, Active, not recruiting, University of Pennsylvania | Trial completion date: Jan 2027 --> Jun 2027
    Trial completion date • Combination therapy
    |
    everolimus • itacitinib (INCB039110)
    10ms
    Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
    P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Feb 2028 --> May 2026 | Trial primary completion date: Feb 2028 --> Jun 2024
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
    |
    Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
    10ms
    Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cyclophosphamide • fludarabine IV • thiotepa • busulfan • itacitinib (INCB039110)
    11ms
    Janus kinase inhibitors modify the fatty acid profile of extracellular vesicles and modulate the immune response. (PubMed, Heliyon)
    to evaluate the interactions between immune system components of healthy individuals and EVs derived from monocytic and lymphoid lineage cells generated in the presence of baricitinib (BARI) and itacitinib (ITA) and their possible effects. The higher proportion of arachidonic acid in the FA content of ITA-L/M-EVs could be related to the thrombosis described in patients treated with ITA. EVs also induced a decrease in the respiratory burst of neutrophils.
    Journal
    |
    IL2RA (Interleukin 2 receptor, alpha) • CD69 (CD69 Molecule) • IL2 (Interleukin 2)
    |
    IL2RA expression • IL2 expression
    |
    itacitinib (INCB039110)
    11ms
    An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=59, Active, not recruiting, Incyte Corporation | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • itacitinib (INCB039110)
    11ms
    GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P2/3, N=155, Terminated, Incyte Corporation | Active, not recruiting --> Terminated; The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision.
    Trial termination
    |
    itacitinib (INCB039110) • methylprednisolone sodium succinate
    11ms
    FLIGHT: Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD (clinicaltrials.gov)
    P2, N=3, Terminated, University of Utah | Trial completion date: Oct 2025 --> Jan 2023 | Active, not recruiting --> Terminated; PI left institution
    Trial completion date • Trial termination
    |
    itacitinib (INCB039110)
    12ms
    NCI-2018-00615: Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas (clinicaltrials.gov)
    P1, N=27, Active, not recruiting, Fred Hutchinson Cancer Center | Trial completion date: Dec 2023 --> Mar 2024
    Trial completion date • Metastases
    |
    CD163 (CD163 Molecule) • ITGAM (Integrin, alpha M)
    |
    itacitinib (INCB039110)
    12ms
    Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study. (PubMed, Cancer Res Commun)
    In this phase I study, patients with advanced solid tumors treated with pembrolizumab (PD-1 inhibitor) and either itacitinib (JAK1 inhibitor) or parsaclisib (PI3Kδ inhibitor) experienced limited clinical activity beyond that expected with checkpoint inhibition alone and showed little effect on T-cell infiltration in the tumor. These results do not support continued development of these combinations.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Keytruda (pembrolizumab) • parsaclisib (INCB50465) • itacitinib (INCB039110)
    1year
    Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation (clinicaltrials.gov)
    P1/2, N=23, Terminated, Incyte Corporation | Active, not recruiting --> Terminated; Business Decision
    Trial termination
    |
    itacitinib (INCB039110)
    1year
    A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=100 --> 18
    Enrollment closed • Enrollment change
    |
    Jakafi (ruxolitinib) • itacitinib (INCB039110)
    1year
    Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2, N=25, Recruiting, Douglas Johnson | Initiation date: Oct 2023 --> Jan 2024
    Trial initiation date • Adverse events • Checkpoint inhibition
    |
    itacitinib (INCB039110)
    1year
    A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov)
    P2, N=15, Terminated, SCRI Development Innovations, LLC | Trial completion date: Jun 2024 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2024 --> Sep 2023; Slow enrollment and PI departure
    Trial completion date • Trial termination • Trial primary completion date
    |
    itacitinib (INCB039110)
    1year
    HLH-JAK, the First Open-Label, Phase II Study Evaluating Anti-JAK1 Itacitinib, for Non Severe HLH in Adults (ASH 2023)
    Kinase inhibitors blocking JAK activity, particularly Ruxolitinib a JAK1/2 inhibitor, have shown some efficacy in murine genetic models of HLH...In the absence of organ failure, fibrinogen<0.5 g/L, platelets<20 G/l, the need for ICU transfer, or etoposide treatment, HLH patients were considered non-severe... As first line treatment, itacitinib monotherapy provided encouraging clinical activity characterized by a high RR and durable response and no safety issues were notified. The second stage of HLH JAK is ongoing. Clinical trial information: NCT NCT05063110
    Clinical • P2 data
    |
    IFNG (Interferon, gamma) • JAK1 (Janus Kinase 1)
    |
    Jakafi (ruxolitinib) • etoposide IV • itacitinib (INCB039110)
    1year
    Itacitinib for Prevention of Graft-Versus-Host Disease and Cytokine Release Syndrome with T-Cell Replete Peripheral Blood Haploidentical Transplantation (ASH 2023)
    GVHD prophylaxis was tacrolimus, mycophenolate mofetil, and post-transplant cyclophosphamide. Itacitinib with PB haplo-HCT was safe with low rates of acute and chronic GVHD, without increased risk of relapse or transplant related mortality. Severe CRS was not seen in this trial, and no anti-IL6 or steroid therapy was used. The addition of Jak inhibition to standard PtCy based GVHD prophylaxis was associated with encouraging rates of GRFS and OS on this pilot and expansion study.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • JAK1 (Janus Kinase 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CD4 (CD4 Molecule) • CD80 (CD80 Molecule) • CD86 (CD86 Molecule)
    |
    LAG3 expression
    |
    cyclophosphamide • itacitinib (INCB039110)
    1year
    Janus Kinase (JAK) 1 Inhibition Results in Significant Changes in Serum Proteins and Peripheral T-Cell Populations That Correlated with Clinical Scores in Chronic Graft Versus Host Disease (GVHD) Patients (an Analysis from GRAVITAS-309) (ASH 2023)
    The dose-finding, open-label, randomized portion of the study initially investigated itacitinib at 200 mg once daily (qd) and 300 mg qd in combination with CS (methylprednisolone or prednisone); both doses were well tolerated. Analysis of patient samples from GRAVITAS-309 revealed that serum elafin and DKK3 levels significantly correlated with skin GVHD scores, possibly reflecting the systemic origin of observed skin manifestations. Serum levels of osteopontin, CXCL9, and CXCL10 were specifically reduced by itacitinib in patients with cGVHD and may represent potential pharmacodynamic markers. Observed changes in different peripheral T-cell populations in patients' samples following itacitinib treatment were consistent with those reported in murine GVHD models, suggesting a potential role of naive CD4+ T cells in driving this disease.
    Clinical
    |
    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • SPP1 (Secreted Phosphoprotein 1) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CCR7 (Chemokine (C-C motif) receptor 7) • DKK3 (Dickkopf WNT Signaling Pathway Inhibitor 3)
    |
    prednisone • itacitinib (INCB039110)