- |||||||||| itacitinib (INCB039110) / Incyte
A pilot study of Janus kinase 1 (JAK1) inhibitor itacitinib for treatment-refractory sarcomas: Leiomyosarcoma cohort. (Hall A - Posters and Exhibits; Poster Bd #: 29) - Apr 23, 2025 - Abstract #ASCO2025ASCO_2048; P1 Itacitinib demonstrated durable disease control in patients with LMS and warrants further study in this subtype. While our analysis of markers on paired biopsy samples does not suggest that immunotherapy combinations with itacitinib are likely to be successful for LMS, a more thorough analysis will be presented at the meeting as this data may still suggest potent combination therapies.
- |||||||||| dezapelisib (INCB040093) / Incyte
Trial completion date, Trial primary completion date: Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - Feb 13, 2025 P1, N=121, Active, not recruiting, Trial registration: clinicaltrials.gov; #NCT04071366. Trial completion date: Jan 2025 --> Apr 2025 | Trial primary completion date: Jan 2025 --> Apr 2025
- |||||||||| itacitinib (INCB039110) / Incyte
Mechanism of CRS: Critical Roles of IFN-?, CD40L, and CD4 Cells. (HCC Ballroom B; In-Person) - Dec 19, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_1334; P1, P2 Further, Lentiviral overexpression of CD40L in CD8 CART19 resulted in robust surface expression and secretion of CD40L as well as dramatic production of IL-6 by iDC (Data not shown). Together, our studies clearly implicate two major pathways that are necessary and sufficient for CRS: 1) IFN-?/IFN-?R/JAK1/2 axis (both CD4 and CD8) and 2) CD40L/CD40 PI3Kg/d axis (exclusively CD4) and represent logical targets for future CRS mitigation strategies in vivo .
- |||||||||| itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date: Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) - Dec 13, 2024 P2, N=27, Recruiting, These encouraging results warrant further studies to evaluate the role of JAK inhibitors to prevent GVHD, replacing MMF. Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Apr 2025
- |||||||||| Hemophagocytic Syndrome Associated with CAR-T Cell Therapy () - Dec 7, 2024 - Abstract #ASH2024ASH_9228;
on the use of drugs for cell therapy-related HLH at EBMT centers, common clinical combinations include corticosteroids + chemotherapy, corticosteroids + monoclonal antibodies + chemotherapy, corticosteroids + chemotherapy + cytokine blockade, corticosteroids + cytokine blockade, and corticosteroids alone. We introduce commonly used specific medications, including etoposide, emapalumab, the IL-six monoclonal antibody siltuximab, the anti-interleukin (IL)-six receptor monoclonal antibody tocilizumab, the interleukin-1 receptor antagonist anakinra, and JAK-one and JAK-two blockers such as ruxolitinib and the JAK-one inhibitor itacitinib, among others.
- |||||||||| Review, Journal: Contemporary Updates in the Prevention and Treatment of Graft-Versus-Host Disease. (Pubmed Central) - Nov 17, 2024
Combinations with novel agents such as itolizumab appear promising for high risk acute GVHD...For chronic GVHD requiring therapy beyond steroids, ruxolitinib, belumosudil, and ibrutinib are now available and should be considered. Increasingly, GVHD has become a manageable complication after allogeneic HCT potentially translating to greater success with allogeneic HCT in the future.
- |||||||||| itacitinib (INCB039110) / Incyte
P1 data, Journal, IO biomarker, Metastases: Safety and efficacy of itacitinib, a selective JAK1 inhibitor, in advanced hepatocellular cancer: Phase 1b trial (JAKAL). (Pubmed Central) - Nov 16, 2024 P1 Tumor biopsies and blood samples will be taken for presence of JAK1 mutations.Activation of JAK/STAT pathway drives HCC development and is associated with immunotherapy resistance. Itacitinib is hypothesized to be safe and effective in HCC patients that have progressed after first-line therapies.Clinical Trial Registration: EudraCT: 2017-004437-81 NCT04358185 (ClinicalTrials.gov).
- |||||||||| itacitinib (INCB039110) / Incyte
Trial primary completion date: Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov) - Nov 14, 2024 P1/2, N=23, Active, not recruiting, Itacitinib is hypothesized to be safe and effective in HCC patients that have progressed after first-line therapies.Clinical Trial Registration: EudraCT: 2017-004437-81 NCT04358185 (ClinicalTrials.gov). Trial primary completion date: Oct 2024 --> May 2024
- |||||||||| parsaclisib (INCB50465) / Incyte
Enrollment closed, Enrollment change: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov) - Nov 1, 2024 P2, N=112, Active, not recruiting, The observed aGVHD rate was lower than our previously published historic data in patients receiving Tac/Siro alone (31% vs. 9%), half of the cases with grade 2-4 aGVHD were diagnosed after day +100 when itacitinib administration stopped per protocol therapy, indicating the need for further refinement in tapering strategy of Tac/Siro/itacitinib, potentially guided by the cytokine/cellular biomarkers identified in our study. Recruiting --> Active, not recruiting | N=200 --> 112
- |||||||||| dezapelisib (INCB040093) / Incyte
Trial completion date, Trial primary completion date: Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - Oct 22, 2024 P1, N=121, Active, not recruiting, Trial completion date: Sep 2024 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2027 Trial completion date: Aug 2024 --> Jan 2025 | Trial primary completion date: Aug 2024 --> Jan 2025
- |||||||||| Campath (alemtuzumab) / Sanofi, itacitinib (INCB039110) / Incyte
Trial completion, Trial completion date, Trial primary completion date: NCI-2019-03203: Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - Sep 26, 2024 P1, N=15, Completed, Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025 Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Sep 2024 | Trial primary completion date: Dec 2026 --> Sep 2024
- |||||||||| Strategies to Mitigate CAR T-Cell-Associated Cytokine Release Syndrome and Neurologic Toxicity (Room A (2F)) - Sep 24, 2024 - Abstract #ICBMT2024ICBMT_47;
I will spotlight promising data from a recent clinical trial investigating the JAK-1 inhibitor itacitinib to prevent CRS and ICANS after axi-cel treatment (Frigault et al., ASH Abstract...Lastly, I will share our experience with anakinra to prevent CRS and ICANS in patients with large B-cell lymphoma receiving the CD19 CAR T-cell product lisocabtagene maraleucel on an investigator-initiated clinical trial (Liang et al., Tandem Meeting Abstract...2023). Learning objectives: - Identify clinical and laboratory factors associated with severe CRS and ICANS - Recognize differences in the toxicity profile across distinct CAR T-cell products - Become acquainted with current toxicity prophylactic strategies
- |||||||||| itacitinib (INCB039110) / Incyte
Trial completion date: Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) - Aug 26, 2024 P2, N=27, Recruiting, Learning objectives: - Identify clinical and laboratory factors associated with severe CRS and ICANS - Recognize differences in the toxicity profile across distinct CAR T-cell products - Become acquainted with current toxicity prophylactic strategies Trial completion date: Nov 2026 --> Dec 2025
- |||||||||| itacitinib (INCB039110) / Incyte, Keytruda (pembrolizumab) / Merck (MSD)
Phase II Study of Pembrolizumab and Itacitinib for Patients with Metastatic NSCLC Expressing PD-L1: Long-Term Follow up (20BC) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_870; P2 Conclusions : Treatment-nai?ve pts with mNSCLC and PD-L1 expression ?50% treated with pembrolizumab and a brief course of JAK inhibition achieved an ORR of 62% at 12 weeks and improvement in mPFS and mOS compared to historical controls (Keynote 24: mPFS 10.3 mo, mOS 30 mo). Interferon signaling modulation through JAK1 inhibition may help prevent resistance to anti-PD1 therapy and should be studied further in a randomized trial.
- |||||||||| itacitinib (INCB039110) / Incyte
Phase classification, Trial completion date: 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) - Jun 26, 2024 P2, N=59, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> May 2024 Phase classification: P2a --> P2 | Trial completion date: May 2024 --> Dec 2024
- |||||||||| itacitinib (INCB039110) / Incyte
Clinical Trial,Phase II, Journal: Combined JAK inhibition and PD-1 immunotherapy for non-small cell lung cancer patients. (Pubmed Central) - Jun 20, 2024 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.
- |||||||||| itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date: Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) - Jun 5, 2024 P2, N=27, Recruiting, Thus, JAK inhibition may improve the efficacy of anti-PD-1 immunotherapy by pivoting T cell differentiation dynamics. Trial completion date: May 2026 --> Nov 2026 | Trial primary completion date: Jun 2024 --> Oct 2024
- |||||||||| Campath (alemtuzumab) / Sanofi, itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date: NCI-2019-03203: Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - May 8, 2024 P1, N=15, Active, not recruiting, stimulation induced proteins in a single generic induction pattern over time whereas TNF?-induced proteins showed distinct grouping of Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026
- |||||||||| itacitinib (INCB039110) / Incyte
Trial termination, Metastases: NCI-2018-00615: Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas (clinicaltrials.gov) - May 7, 2024 P1, N=27, Terminated, 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.
- |||||||||| dezapelisib (INCB040093) / Incyte
Trial completion date, Trial primary completion date: Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - Mar 13, 2024 P1, N=121, Active, not recruiting, Recruiting --> Active, not recruiting Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024
- |||||||||| itacitinib (INCB039110) / Incyte
Enrollment open: Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) - Mar 13, 2024 P1, N=31, Recruiting, Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024 Active, not recruiting --> Recruiting
- |||||||||| Inrebic (fedratinib) / BMS, Jakafi (ruxolitinib) / Incyte, itacitinib (INCB039110) / Incyte
Preclinical, Journal: Differential Effects of JAK1 vs. JAK2 Inhibition in Mouse Models of Hemophagocytic Lymphohistiocytosis. (Pubmed Central) - Mar 6, 2024 Consistent with its superior clinical effects, ruxolitinib exerted the greatest transcriptional changes in CD8 T cells and monocytes, targeting more genes across several biologic pathways, most notably JAK-dependent pro-inflammatory signaling. We conclude that JAK1 inhibition is sufficient to curtail CpG-induced disease, but combined inhibition of JAK1 and JAK2 is needed to best control LCMV-induced immunopathology.
- |||||||||| itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date: Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) - Feb 22, 2024 P1, N=30, Active, not recruiting, Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Feb 2024 --> Jun 2024 Trial completion date: Feb 2027 --> Apr 2025 | Trial primary completion date: Feb 2027 --> Apr 2025
- |||||||||| itacitinib (INCB039110) / Incyte
Trial completion date: Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov) - Feb 21, 2024 P1/2, N=23, Active, not recruiting, Trial completion date: Feb 2027 --> Apr 2025 | Trial primary completion date: Feb 2027 --> Apr 2025 Trial completion date: Jan 2027 --> Jun 2027
- |||||||||| itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date: Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) - Feb 15, 2024 P2, N=27, Recruiting, Trial completion date: Jan 2027 --> Jun 2027 Trial completion date: Feb 2028 --> May 2026 | Trial primary completion date: Feb 2028 --> Jun 2024
- |||||||||| itacitinib (INCB039110) / Incyte
ITACITINIB FOR THE PREVENTION OF IMMUNE EFFECTOR CELL THERAPY (Hall 3 South) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1900; P2 Incidence of grade 3/4 neutropenia and thrombocytopenia not resolved at Day 28 was higher with itacitinib vs placebo. Severe infection rates were comparable
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