itacitinib (INCB039110) / Incyte, Innovent Biologics - LARVOL DELTA

Adebrelimab Plus Ivarmacitinib With or Without Chemotherapy as First-Line Treatment for Advanced NSCLC: A Phase 2 Trial (IASLC-WCLC 2026) - P2, P4 | "First-line pembrolizumab plus itacitinib (NCT03425006) resulted in a 12-week objective response rate (ORR) of 62% and a median progression-free survival (PFS) of 15.6 months in 23 patients with metastatic NSCLC and PD-L1 tumor proportion score (TPS) ≥50%...Cohort B will additionally receive platinum-based doublet chemotherapy for 2 cycles (if pemetrexed is used for non-squamous NSCLC, it will be continued until disease progression or intolerable toxicity) since the initiation of adebrelimab treatment...The 95% confidence intervals (CIs) of ORR and DCR will be calculated using the Clopper-Pearson method. Median survival will be estimated using the Kaplan-Meier method, and the corresponding 95% CIs will be calculated using the Brookmeyer-Crowley method."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • CD8 • EGFR • MET • ROS1

Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) - P2 | N=27 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jun 2026 ➔ Feb 2027

Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CRP • JAK1

Itacitinib for the Prevention of Immune Effector Cell Therapy–Associated Cytokine Release Syndrome: Results from the Phase 2 Incb 39110-211 Placebo-Controlled Randomized Cohort (ASH 2023) - P2 | "Protocol did not allow tocilizumab for treatment of grade 1 CRS unless CRS did not improve after 72 hours of supportive treatment. Results from the randomized, placebo-controlled portion of Study INCB 39110-211 have shown prophylaxis treatment with itacitinib 200 mg bid to be well tolerated and resulted in a lower rate and grade of CRS and ICANS after lymphoma treatment with axicabtagene ciloleucel. Incidence of grade 3/4 neutropenia and thrombocytopenia not resolved at Day 28 was higher with itacitinib vs placebo. Rates of severe infections were comparable in both arms."

Clinical • Cytokine release syndrome • IO biomarker • P2 data • B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hypotension • Infectious Disease • Inflammation • Large B Cell Lymphoma • Lymphoma • Nephrology • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock • Thrombocytopenia

Phase II Study of Pembrolizumab and Itacitinib for First Line Treatment of Metastatic NSCLC Expressing PD-L1 (IASLC-WCLC 2022) - "Treatment-naïve pts with mNSCLC and PD-L1 expression ≥50% treated with pembrolizumab and a brief course of JAK inhibition starting at week 6 of treatment resulted in an ORR of 62% at 12 weeks and mPFS of 23.4 months. This novel combination was well tolerated. Interferon signaling modulation through JAK1 inhibition may help prevent resistance to anti-PD1 therapy and should be studied further in a randomized trial."

Clinical • IO biomarker • P2 data • Dermatology • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • JAK2 • PD-L1

Phase II Study of Pembrolizumab and Itacitinib for Patients with Metastatic NSCLC Expressing PD-L1: Long-Term Follow up (IASLC-WCLC 2024) - P2 | "Conclusions : Treatment-naïve 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."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • JAK2 • PD-L1

Phase 1B pilot study of itacitinib with alemtuzumab in patients with T-cell prolymphocytic leukemia. (PubMed, Blood Neoplasia) - P1 | "Continued studies evaluating JAK inhibitors in patients with T-PLL are warranted. This trial was registered at www.clinicaltrials.gov as #NCT03989466."

Clinical • Journal • P1 data • Hematological Malignancies • Leukemia • Oncology • Prolymphocytic Leukemia • Transplantation • IL2RG • JAK3 • STAT5B • TCL1A

Itacitinib for the Prevention of IEC Therapy-Associated CRS: Results From the Two-Part Phase 2 INCB 39110-211 Study. (PubMed, Blood) - P2 | "Patients in part 1 received once-daily itacitinib 200 mg 3 days before IEC therapy (axicabtagene ciloleucel [axi-cel], brexucabtagene autoleucel, or tisagenlecleucel) through Day 26, with guidelines for use of other CRS/ICANS interventions. Importantly, itacitinib did not impact IEC therapy efficacy (objective response rate at 6 months: 39.1% for itacitinib 200 mg bid vs 26.1% for placebo). Trial registration: clinicaltrials.gov; #NCT04071366."

Journal • P2 data • Hematological Disorders • Hematological Malignancies • Oncology

Itacitinib plus calcineurin inhibitor-based therapy for prophylaxis of graft-versus-host disease: GRAVITAS-119 results. (PubMed, Res Sq) - P1 | "Of 84 enrolled patients, 41 received itacitinib plus tacrolimus/methotrexate (nine with antithymocyte globulin [ATG]), 24 received itacitinib plus cyclosporine A/mycophenolate mofetil (16 with ATG), and 19 received itacitinib plus post-transplant cyclophosphamide/tacrolimus. Most patients receiving itacitinib plus standard-of-care GVHD prophylaxis achieved hematologic recovery, with any-grade GVHD and infection rates similar to previous reports with standard-of-care prophylaxis. Addition of itacitinib to GVHD prophylaxis permits timely hematologic recovery and does not increase GVHD or infection rates, although unmet need still remains for improved regimens."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Transplantation

A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (clinicaltrials.gov) - P2 | N=18 | Terminated | Sponsor: Incyte Corporation | Active, not recruiting ➔ Terminated; The decision to close the study was made due to the expiration of remaining drug supply.

Trial termination • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Myelofibrosis • Pulmonary Disease • Respiratory Diseases • Transplantation

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 | Sponsor: Incyte Corporation | Trial completion date: Sep 2027 ➔ Nov 2026 | Trial primary completion date: Sep 2027 ➔ Nov 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology

TOWARDS A MOUSE MODEL FOR LYMPHOPROLIFERATION INDUCED BY IL4R MUTATION IN PMBL (EHA 2026) - "Pharmacologic JAK1 inhibition (itacitinib) selectively reduced mutant-driven proliferation, further supporting JAK1 dependency...****P < 0.0001; **P < 0.01. Eight weeks post-transplantation, mice display early thymic lymphoid expansion without overt lymphoma."

Preclinical • B Cell Lymphoma • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma • FCER2 • IL13RA2 • IL4R • IL4R • JAK1 • JAK3 • STAT6 • TYK2

Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patients. (PubMed, J Eur Acad Dermatol Venereol) - "This meta-analysis provides a comprehensive assessment of the risk of infection associated with JAK-STAT inhibitors in IMIDs of the skin. Although overall safety is acceptable, clinicians should be aware of the higher infection risk of influenza and herpes zoster and should consider vaccination and preventive strategies for high-risk patients with atopic dermatitis. The main limitation is that the included studies involved highly selected populations with few comorbidities and short follow-up."

Journal • Retrospective data • Review • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Herpes Zoster • Immunology • Infectious Disease • Inflammation • Influenza • Pulmonary Disease • Respiratory Diseases • Varicella Zoster • Vitiligo

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=20 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: May 2026 ➔ Mar 2027 | Trial primary completion date: May 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Myelomonocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Transplantation

Theranostics of immune-related adverse events in cardio-oncology based on CCR2 PET imaging (SNMMI 2026) - "CCR2 PET imaging using 64Cu-DOTA-ECL1i can monitor both tumor progression and inflammation of atherosclerosis more specifically than 18F-FDG. Treatment with aPD1 reduces tumor progression but increases CCR2 expression in atherosclerotic lesions compared to IgG2 treatment. Co-treatment of JAK1i itacitinib with aPD1 improves tumor response and reduces CCR2 expression in atherosclerotic plaques."

Adverse events • IO biomarker • Atherosclerosis • Cardiovascular • Congestive Heart Failure • Head and Neck Cancer • Heart Failure • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • APOE • CCR2 • CD8 • IFNG

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1 | N=121 | Completed | Sponsor: Incyte Corporation | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Oncology

JAKaL: Itacitinib in Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Imperial College London | Active, not recruiting ➔ Completed

Trial completion • Hepatocellular Cancer • Oncology • Solid Tumor

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 | Completed | Sponsor: City of Hope Medical Center | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Oct 2025

Trial completion • Trial completion date • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Myelofibrosis • Oncology • Transplantation

INCIDENCE OF EBV DNAEMIA AND POSTTRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD) AMONG HCT WITH POSTTRANSPLANT CYCLOPHOSPHAMIDE (PTCY). A SINGLE CENTER EXPERIENCE (EBMT 2026) - "Patients received bone marrow or peripheral blood stem cell (PBSC) graft on Day (D) 0; PTCy (50 mg/kg/day) was given on D +3 and +4, and tacrolimus (or sirolimus) plus mycophenolate mofetil (or investigational itacitinib) starting on D +5...Of 18 patients treated with Rituximab, 17 (94.4%) cleared EBV DNAemia and 1 patient died with EBV DNAemia from GVHD... 1) The cumulative incidence of EBV viremia and cs-EBV DNAemia at D +365 among PTCy recipients was 15.8% and 4.3% respectively. 2) Probable PTLD developed in 10 (2.4%) patients. 3) ATG was associated with cs-EBV DNAemia and probable PTLD."

Clinical • Post-transplantation • Graft versus Host Disease • Immunology • Transplantation

PERI-TRANSPLANT RUXOLITINIB FOR GRAFT-VS-HOST-DISEASE (GVHD) PREVENTION IN PEDIATRIC AND YOUNG ADULT PATIENTS UNDERGOING MYELOABLATIVE HEMATOPOIETIC CELL TRANSPLANTATION (HCT): INTERIM ANALYSIS (EBMT 2026) - P2 | "Similarly, our group showed that peri-HCT itacitinib, another JAK 1 inhibitor, is safe when added to tacrolimus/sirolimus as GVHD prophylaxis, with 100% engraftment and low rates of acute/chronic GVHD in adults. We show that peri-HCT ruxolitinib did not interfere with engraftment post-HCT. In addition, our data supports the safety and feasibility of adding ruxolitinib to tacrolimus/methotrexate as GVHD prophylaxis in young patients receiving HCT. Accrual is ongoing."

Clinical • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Infectious Disease • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Pediatrics • Transplantation

CHARACTERISTICS OF CLINICAL TRIALS IN GRAFT-VERSUS-HOST DISEASE: LANDSCAPE OF STUDY DRUGS AND ASSESSMENT OF OUTCOME MEASURES (EBMT 2026) - "The most frequent treatments studied were corticosteroids (n=64), followed by mesenchymal stem cells (n=52), ruxolitinib (n=31), extracorporeal photopheresis (n=26), fecal microbiota transplantation (n=17), rituximab (n=15), belumosudil and cyclosporin (n=13 each), itacitinib (n=11), axatilimab and donor regulatory T-cells (n=10 each), and ibrutinib (n=9). Acute and chronic GvHD remain major areas of clinical research, with their distinct clinical courses reflected in differences in trial design and outcome measures. Recent shifts toward multicenter designs, shorter study durations, and more frequent evaluation of targeted therapies suggest evolving priorities and growing methodological maturity in GvHD trial planning."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

ITACITINIB IN COMBINATION WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE AND TACROLIMUS (ICT) AS GVHD PROPHYLAXIS FOR REDUCED INTENSITY MATCHED DONOR HEMATOPOIETIC CELL TRANSPLANTATION (HCT): FINAL ANALYSIS (EBMT 2026) - P2 | "We conducted a single-center study (NCT05364762) evaluating the safety of adding itacitinib to PTCy-based prophylaxis with tacrolimus, for 60 or 90 days, in patients undergoing matched related or unrelated peripheral blood stem cell (PBSC) HCT following fludarabine (25 mg/m2: days -7 to -3) and melphalan (100 mg/m2: day -2) conditioning. Adding itacitinib to PTCy and tacrolimus-based GVHD prophylaxis (ICT) was safe and well-tolerated, with low GVHD rates, no NRM, and promising 1-year survival. These results support further study of JAK1 inhibition with the PTCy platform to optimize immune tolerance post-HCT."

Combination therapy • Post-transplantation • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Chronic Myelomonocytic Leukemia • Febrile Neutropenia • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Neutropenia • Septic Shock • Thrombocytopenia • Transplantation

PERI-TRANSPLANT RUXOLITINIB FOR GRAFT-VS-HOST-DISEASE (GVHD) PREVENTION IN PEDIATRIC AND YOUNG ADULT PATIENTS UNDERGOING MYELOABLATIVE HEMATOPOIETIC CELL TRANSPLANTATION (HCT): INTERIM ANALYSIS (EBMT 2026) - P2 | "Similarly, our group showed that peri-HCT itacitinib, another JAK 1 inhibitor, is safe when added to tacrolimus/sirolimus as GVHD prophylaxis, with 100% engraftment and low rates of acute/chronic GVHD in adults. We show that peri-HCT ruxolitinib did not interfere with engraftment post-HCT. In addition, our data supports the safety and feasibility of adding ruxolitinib to tacrolimus/methotrexate as GVHD prophylaxis in young patients receiving HCT. Accrual is ongoing."

Clinical • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Infectious Disease • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Pediatrics • Transplantation

INCIDENCE OF EBV DNAEMIA AND POSTTRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD) AMONG HCT WITH POSTTRANSPLANT CYCLOPHOSPHAMIDE (PTCY). A SINGLE CENTER EXPERIENCE (EBMT 2026) - "Patients received bone marrow or peripheral blood stem cell (PBSC) graft on Day (D) 0; PTCy (50 mg/kg/day) was given on D +3 and +4, and tacrolimus (or sirolimus) plus mycophenolate mofetil (or investigational itacitinib) starting on D +5...Of 18 patients treated with Rituximab, 17 (94.4%) cleared EBV DNAemia and 1 patient died with EBV DNAemia from GVHD... 1) The cumulative incidence of EBV viremia and cs-EBV DNAemia at D +365 among PTCy recipients was 15.8% and 4.3% respectively. 2) Probable PTLD developed in 10 (2.4%) patients. 3) ATG was associated with cs-EBV DNAemia and probable PTLD."

Clinical • Post-transplantation • Graft versus Host Disease • Immunology • Transplantation

CHARACTERISTICS OF CLINICAL TRIALS IN GRAFT-VERSUS-HOST DISEASE: LANDSCAPE OF STUDY DRUGS AND ASSESSMENT OF OUTCOME MEASURES (EBMT 2026) - "The most frequent treatments studied were corticosteroids (n=64), followed by mesenchymal stem cells (n=52), ruxolitinib (n=31), extracorporeal photopheresis (n=26), fecal microbiota transplantation (n=17), rituximab (n=15), belumosudil and cyclosporin (n=13 each), itacitinib (n=11), axatilimab and donor regulatory T-cells (n=10 each), and ibrutinib (n=9). Acute and chronic GvHD remain major areas of clinical research, with their distinct clinical courses reflected in differences in trial design and outcome measures. Recent shifts toward multicenter designs, shorter study durations, and more frequent evaluation of targeted therapies suggest evolving priorities and growing methodological maturity in GvHD trial planning."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Experimental JAK inhibitors: the current, present and future in graft-versus-host disease management? (PubMed, Expert Opin Investig Drugs) - "We evaluate the efficacy and safety of selective and nonselective agents, including ruxolitinib, baricitinib, itacitinib, pacritinib, and rovadicitinib. We anticipate a transition from the current 'steroid-first' paradigm to risk-stratified algorithms utilizing biomarker profiling and novel combination strategies. While ruxolitinib is the current cornerstone, the development of highly selective inhibitors and the resolution of financial access barriers will be crucial for establishing JAK inhibitors as the frontline standard of care over the next decade."

Journal • Review • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation