Poteligeo (mogamulizumab-kpkc) / Kyowa Kirin, Swixx BioPharma - LARVOL DELTA

A phase I dose-finding study of mogamulizumab in combination with brentuximab vedotin in previously treated mycosis fungoides and Sézary syndrome (ASH 2025) - P1 | "Enrollment is ongoing and additional pt data will be presented at the meeting. Acknowledgements: Drug support and trial funding for this study were provided by Pfizer and Kyowa Kirin, Inc."

Combination therapy • P1 data • Cutaneous T-cell Lymphoma • Dermatology • Musculoskeletal Pain • Mycosis Fungoides • Oncology • Sezary Syndrome • CCR4 • TNFRSF8

Rare cancer, rare survivors: A 20-year single-center review of adult T-cell lymphoma/leukemia treatment outcomes (ASH 2025) - "Among acute ATLL pts (n=25), initial therapy included CHOP or CHOEP (40%), hyperCVAD (28%), and Zidovudine + interferon a (AZT+IFN) (20%)...Among lymphomatous subtypes pts (n=24), the majority received CHOP-based regimens initially (79%), followed by salvage with ICE, pralatrexate, or romidepsin...A small number of long-term survivors were observed in acute ATLL with limited tumor burden in the lymph node involvement, associated with early use of AZT+IFN, followed by mogamulizumab, or AlloHCT...Unfortunately, we currently lack highly effective frontline treatment options, which makes consolidative strategies such as transplantation difficult to execute. These findings underscore the urgent need for earlier recognition, subtype-adapted therapy, and suggest the incorporation of antiviral and immune-based strategies to improve ATLL outcomes."

Clinical • Review • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Cutaneous T-cell Lymphoma • Endocrine Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Cytokine signatures predict response, progression, and immune-related toxicity in Sézary syndrome patients treated with mogamulizumab (ASH 2025) - "MAR correlated with low IL-8 and elevated IL-1β. These findingssupport the potential utility of serial cytokine profiling to inform prognosis and personalize therapy in thisrare lymphoma subtype."

Clinical • Cutaneous T-cell Lymphoma • Dermatopathology • Hematological Malignancies • Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CCR4 • CXCL8 • IL10 • IL1B • IL2RA • IL6 • TNFA

Persistent racial disparities in Sézary syndrome outcomes despite use of modern therapies: A single-center analysis (ASH 2025) - "With theincreasing use of modern systemic therapies (e.g., mogamulizumab, brentuximab vedotin, interferons,photopheresis) over the past decade, we sought to determine whether survival disparities by race persistin the current treatment era.MethodsWe retrospectively reviewed 75 patients with SS treated between January 2015 and June 2025 at MoffittCancer Center...Black patients were more likely toreceive ECP + Pegasys (69.2% vs. 26.8%), romidepsin (61.5% vs. 37.5%), brentuximab (38.5% vs. 14.3%),and combination chemotherapy (61.5% vs. 19.6%) compared to White patients, likely reflecting the moreaggressive nature of their disease.ConclusionOur cohort demonstrated better OS compared to historical studies, likely reflecting the impact of modernsystemic therapies and specialized care at a tertiary center...Black patients in our cohort had a markedly higher prevalence of large-celltransformation, earlier age at diagnosis, and more advanced clinical stage at presentation,..."

Clinical • Cutaneous T-cell Lymphoma • Dermatopathology • Hematological Malignancies • Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Genomic alterations in TET2 and EZH2 serve as critical drivers of clonal malignant evolution in anti-BCMA CAR-T therapy for multiple myeloma. (ASH 2025) - "CCR4+ is a skin homing chemokine which was expressed in all ourpatient's malignant CAR-T tumor cells and served as an indicator for treatment with mogamulizumab.EZH2 and TET2 double mutant almost tripled the expression of CCR4 compared to control and caused aloss of CD7 in 73% of cells... TET2 and EZH2 mutations result in epigenetic changes such as open chromatin, leaving thegenome more vulnerable to additional alterations. TET2 and EZH2-loss of function mutations in CAR-Tcells provide advantages in proliferation and regeneration while promoting malignant CAR-Ttransformation following anti-BCMA CAR-T therapy."

IO biomarker • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CCR4 • CD4 • CD69 • CD7 • CD8 • IL7R • TET2

Can the development of drug-induced rash after mogamulizumab administration predict survival in mycosis fungoides/sezary syndrome? a trinetx-based analysis (ASH 2025) - "A diagnosis of SS was not found to have an influence on survival. A majorlimitation of this study is the lack of ability to precisely query for MAR using this database as well as theclinical challenge of distinguishing between MAR and disease relapse."

IO biomarker • Cutaneous T-cell Lymphoma • Dermatology • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • CCR4

Heterogeneity of circulating CD57+ cytotoxic cell subsets across disease stage and aggressiveness in cutaneous T cell lymphoma (ASH 2025) - "Aggressivecourse was defined as death from disease within two years or progression requiring systemic HDACinhibitors, chemotherapy, or alemtuzumab after failure of mogamulizumab and extracorporealphotopheresis. Circulating CD57⁺ subsets demonstrate significant variation across CTCL disease states and SSsubgroups. CD57⁺CD4⁺ T cells were most elevated at SS diagnosis, particularly in aggressive cases,suggesting a potential role in disease onset or progression. CD57⁺ NK cells were increased in bothaggressive SS at diagnosis and less aggressive treated SS, indicating a possible immune response fromtreatment or disease burden rather than aggressiveness alone."

Heterogeneity • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Hematological Malignancies • Human Immunodeficiency Virus • Immunology • Infectious Disease • Lymphoma • Mycosis Fungoides • Sezary Syndrome • Solid Tumor • T Cell Non-Hodgkin Lymphoma • B3GAT1 • CD4 • CD8

Real-world monotherapy and combination usage of mogamulizumab among patients with mycosis fungoides or Sézary syndrome in the United States (ASH 2025) - "The most common systemic CT options were bexarotene(8 pts [27.6%]), extracorporeal photopheresis ([ECP] 7 pts [24.1%]), and methotrexate (5 pts [17.2%]) withsome differences between MF and SS.Of 99 pts with results in the response assessment period, physician-reported response was documentedin 47/70 pts (67.1%) on MT and 21/29 pts (72.4%) on CT. Response rate,TTNT, and PFS were numerically higher with CT. Study limitations include potential for incomplete orincorrect documentation in medical records and lack of standardized response assessment criteria; however, this analysis demonstrates safety and a potential benefit of mogamulizumab in CT for pts withMF/SS."

Clinical • Monotherapy • Real-world • Real-world evidence • Cutaneous T-cell Lymphoma • Dermatology • Infectious Disease • Mycosis Fungoides • Oncology • Pneumonia • Pruritus • Respiratory Diseases • Septic Shock • Sezary Syndrome

Improved survival after post-transplant relapse of adult t-cell leukemia-lymphoma and trends of salvage therapy (ASH 2025) - "Regarding salvage therapy for post-transplant R/R ATL, while mogamulizumab (Mog) or lenalidomide(Len) was used in less than 3% of patients during the early and middle periods, the utilization of theseagents increased in the late period: Mog (20.8%) and Len (11.8%) in the Refractory group; and Mog(27.6%) and Len (21.2%) in the Relapse group. We observed significant increases in (i) the useof RIC regimen and (ii) patients with better HCT-CI and PS at allo-HSCT, which may have expanded thepopulation eligible for salvage therapy due to improved tolerability. Furthermore, it is important to notethat the Introduction of Mog and Len would contribute to improved survival of patients with the post-transplant R/R ATL in the late period."

Clinical • Post-transplantation • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Transplantation

Clinical features and outcomes of patients with non-erythrodermic mycosis fungoides with high blood tumor burden (ASH 2025) - "Interrogation of 9 neSS patient samples forcancer-associated mutations showed known disease-associated variants in TP53 (n=3), PTEN (n=1),DNMT3A (n=1) and EGR2 (n=1).The median number of systemic treatments for neSS patients was similar to cSS patients (3.5 vs 3).Among the neSS patient cohort, systemic treatments included extracorporeal photopheresis (ECP)(n=16),bexarotene (n=11), interferon (IFN)(n=8), mogamulizumab (n=8), romidepsin (n=4), brentuximab vedotin(BV)(n=3), pembrolizumab (n=3), chemotherapy (n=1), methotrexate (n=1) and clinical trial (n=1). Non-erythrodermic patients with B2 disease (T0-2/B2, neSS) had a significantly betterprognosis compared to classic SS patients with erythroderma (T4/B2, cSS). neSS patients receivedmultiple systemic treatments; however, 4 patients with minimal skin disease were managed withsurveillance or skin-directed therapy alone. Only 3 neSS patients (9.6%) later developed erythroderma.Although neSS patients were more often women..."

Clinical • IO biomarker • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Pruritus • Sezary Syndrome • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD4 • CD7 • CD8 • DNMT3A • DPP4 • PTEN • TP53

GATA-3 identifies a distinct subset of T-cell prolymphocytic leukemia (T-PLL) and is associated with CCR4 expression (ASH 2025) - "The correlation between GATA-3 and CCR4 expression in our cohort isnotable, as the CCR4 specific monoclonal antibody mogamulizumab is approved for other CCR4-expressing T-cell lymphomas, including those with peripheral blood involvement.The cytogenetic landscape differed markedly by GATA-3 status: GATA-3 positive patients exhibited morefrequent complex karyotypes and had universal aberration of chromosomes 11 and 14.Immunophenotypically, GATA-3 positive cases were uniformly CD4+ and CD8-.Despite differences in both baseline features and cytogenetics, GATA-3 expression was not associatedwith significantly worse response to treatment or survival, despite the lower rate of allogeneic stem celltransplantation.While our findings are limited by the small sample size, they underscore the importance of biologicstratification in T-PLL. 25 patients were evaluated with a median follow-up of 29 months (range: 4-270). GATA-3 wasintensely and uniformly expressed in 44% of patients...."

IO biomarker • Hematological Malignancies • Leukemia • Lymphoma • Peripheral T-cell Lymphoma • Prolymphocytic Leukemia • T Cell Non-Hodgkin Lymphoma • CCR4 • CD4 • CD8 • GATA3

A Phase 2, multicenter, open-label, single-arm study assessing a 4-weekly dosing schedule for mogamulizumab in patients with mycosis fungoides/Sézary syndrome (MOGA-2MG-Q4W) (ASH 2025) - P2 | "Although an increased rate of drug eruption relative to other trials wasseen, this may have resulted from improved investigator experience discerning rash from PD since initialtrials. Exploratory data on mutational profiles and immune response may allow for optimizing patientselection and management."

Clinical • IO biomarker • P2 data • CNS Disorders • Cutaneous T-cell Lymphoma • Dermatology • Mycosis Fungoides • Oncology • Sezary Syndrome • Skin Cancer • CCR4

Diagnostic and therapeutic patterns in cutaneous T-cell lymphomas (CTCL): Real-world data from the lymphoma epidemiology outcome-molecular epidemiology resource (LEO-MER) prospective cohort study. (ASH 2025) - P=N/A | "First-line (1L)systemic regimens were predominantly a) immunomodulatory agents (n=47, 29.3%); including oralretinoid (n=20), extracorporeal photopheresis (n=18), interferon (n=9) followed by b) chemotherapy(n=30, 18.7%) and c) targeted therapies (n=17, 10.6%) including Brentuximab Vedotin (n=6), Romidepsin(n=5), Mogamulizumab (n=3), Vorinostat (n=2) and Pralatrexate (n=1). We present initial data from our prospective LEO-MER cohort, a large US-based multicenter consortia.Our findings demonstrate variability in both diagnostic staging and treatment approaches for MF/SSpatients. The cohort demonstrated worse outcomes with high-risk disease and Black race/ethnicity.These findings warrant further study on the impact of underlying social determinant factors, given thevariability noted in this population."

Clinical • Real-world • Real-world evidence • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD4

Integrated analysis of mogamulizumab trials for mature T-cell lymphomas, investigating differences in longitudinal effects between responders and non-responders (ASH 2025) - "This analysis shows the effect of moga on CCR4+ cells and its ligands. In CTCL, longitudinaldecreases in lymphocyte counts, CD4+ cell counts and CCL17/22 serum levels preceded mSWAT scoredecrease in R. In ATL and PTCL there are clear differences in BL counts for lymphocytes, CD4+ and/orFoxP3+ cells in R vs N. Additionally, CCL17/22 increases are seen in pts with r/r ATL with cAEs. Theseresults further suggest that moga's effects on CCR4 ligands and the ligands' usefulness as responsebiomarkers differs between lymphomas."

IO biomarker • Adult T-Cell Leukemia-Lymphoma • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Leukemia • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Sezary Syndrome • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CCL2 • CCL22 • CCR4 • CD4 • FOXP3 • IL2RA

Outcomes in octo- and nonagenarians treated with mogamulizumab-based regimens for cutaneous T-cell lymphoma (ASH 2025) - "Combinationtherapy was used based on institutional practice in 13 pts (68%) including interferon alpha (6/13,46%),bexarotene (6/13,46%), interferon gamma (7/13,54%) and extracorporeal photopheresis (8/13, 62%)...Cytopenias were observed in 15 pts (79%) with 7/15 ( 46%) having grade 3 or 4 cytopenias.Biopsy confirmed moga-associated rash (MAR) was observed in 9 pts (47%) all of which resolved withtopical corticosteroids (7/9, 78%) and/or oral methotrexate (2/9, 22%)... Nineteen pts were identified (13 SS [68%], 6 MF [32%]); median age was 82 (range:80–94). Ten(53%) were male and 16 (84%) were White. Thirteen (68%) had ECOG 0-1 and 15 (79%) had advancedstage disease."

CNS Disorders • Cutaneous T-cell Lymphoma • Dermatology • Endocrine Disorders • Lymphoma • Mycosis Fungoides • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CCR4 • IFNG

P087 Not so mycosis fungoides. (PubMed, Br J Dermatol) - "Case 3 is a 75-year-old man with stage IVA2 MF who developed red, itchy patches in flexural folds during psoralen-ultraviolet A and pegylated interferon therapy...She had a diagnosis of nonerythrodermic SS and palmoplantar hyperkeratosis, and had a complete response in blood and a partial response in skin following mogamulizumab-methotrexate combination therapy...Treatment options for MF, such as topical corticosteroids, phototherapy and systemic therapies, can suppress the immune system, thereby raising the risk of fungal skin infections. Our case series highlights that fungal skin infections can mimic MF in patients with MF/SS and emphasizes the importance of considering a secondary diagnosis when reviewing and treating these patients, particularly if they present with a new atypical rash."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Mycosis Fungoides • Oncology • Psoriasis • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

BI10 (P084) Translating clinical trials into practice: real-life experience using mogamulizumab in the treatment of mycosis fungoides and Sézary syndrome in a single centre of 29 patients. (PubMed, Br J Dermatol) - "Two ADRs, neutropenia (grade 4, n = 1) and persistent idiopathic headache (n = 1), prompted discontinuation of mogamulizumab treatment. In conclusion, this retrospective evaluation confirms the real-world efficacy of mogamulizumab, with results similar to those reported in clinical trial data."

Journal • Retrospective data • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Neutropenia • Oncology • Pain • Sezary Syndrome • Solid Tumor • T Cell Non-Hodgkin Lymphoma

P084 Translating clinical trials into practice: real-life experience using mogamulizumab in the treatment of mycosis fungoides and Sézary syndrome in a single centre of 29 patients. (PubMed, Br J Dermatol) - "Two ADRs, neutropenia (grade 4, n = 1) and persistent idiopathic headache (n = 1), prompted discontinuation of mogamulizumab treatment. In conclusion, this retrospective evaluation confirms the real-world efficacy of mogamulizumab, with results similar to those reported in clinical trial data."

Journal • Retrospective data • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Neutropenia • Oncology • Pain • Sezary Syndrome • Solid Tumor • T Cell Non-Hodgkin Lymphoma

C-C chemokine receptor 4 is a candidate for regulatory T-cell-depletion immunotherapy in differentiated thyroid cancer. (PubMed, Auris Nasus Larynx) - "Tregs were increased and activated in DTC tumor tissue, indicating that they play an important role in creating an immunosuppressive microenvironment in DTC. The results suggest that eTreg-depletion immunotherapy using an anti-CCR4 antibody (mogamulizumab) might be effective for treating DTC."

IO biomarker • Journal • Endocrine Disorders • Oncology • Solid Tumor • Thyroid Gland Carcinoma • CCR4 • FOXP3 • HAVCR2 • PD-1

Targeted therapies and resistance mechanisms in lymphoma: Current landscape and emerging solutions. (PubMed, Oncoscience) - "We comprehensively evaluate FDA-approved targeted agents, including monoclonal antibodies (rituximab, brentuximab vedotin, obinutuzumab, mogamulizumab), immune checkpoint inhibitors (nivolumab, pembrolizumab), CAR T-cell therapies (axi-cel, tisa-cel, liso-cel, brexu-cel), bispecific T-cell engagers (mosunetuzumab, epcoritamab), and small-molecule inhibitors (ibrutinib, idelalisib, venetoclax). In conclusion, understanding the molecular basis of lymphoma and resistance mechanisms is critical to optimizing targeted therapy. This review synthesizes current evidence to inform clinical decision-making and outlines future directions for durable, personalized lymphoma care."

IO biomarker • Journal • Review • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BTK • CCR4 • CD20 • TNFRSF8

Adult T-cell leukemia/lymphoma treated with mogamulizumab followed by allogeneic stem cell transplantation after bridging therapy with valemetostat (PubMed, Rinsho Ketsueki) - "Although valemetostat bridging therapy controlled ATLL and allowed for a treatment-free interval after mogamulizumab therapy, it delayed regulatory T cell (Treg) recovery and caused severe aGVHD. Further improvements are needed in the management of severe GVHD after mogamulizumab administration, such as monitoring of Tregs and residual mogamulizumab concentrations."

Journal • Acute Graft versus Host Disease • Adult T-Cell Leukemia-Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Inverse Psoriasis-Like Mogamulizumab-Associated Rash in a Patient with Cutaneous T-cell Lymphoma (ISDS 2025) - "Mogamulizumab-associated rash (MAR) is a heterogeneous cutaneous reaction to mogamulizumab often seen in patients with cutaneous T-cell lymphoma (CTCL). Here, we highlight a unique clinical pattern of MAR that resembles inverse psoriasis. This case emphasizes the heterogeneity of MAR, while also illustrating methotrexate as an effective therapy for both CTCL and MAR in this context."

Clinical • Cutaneous T-cell Lymphoma • Dermatitis • Dermatology • Hematological Malignancies • Immunology • Lymphoma • Mycosis Fungoides • Psoriasis • T Cell Non-Hodgkin Lymphoma • CD8

Clinical Outcomes of Tucidinostat Therapy for Relapsed/Refractory Adult T-Cell Leukemia-Lymphoma (ATL) in Clinical Practice (ASH 2023) - "The median number of prior treatment regimens was 2 (1-4), with 19 cases of multi-drug combination chemotherapy, 18 cases of mogamulizumab, and 5 cases of oral chemotherapy. Conclusion In relapsed/refractory ATL, Tucidinostat achieved treatment results similar to those in the phase IIb trial in clinical practice. In particular, for cases with an sIL2-R value of less than 5000, it was suggested that Tucidinostat may be a meaningful treatment option."

Clinical • Clinical data • Adult T-Cell Leukemia-Lymphoma • CNS Disorders • Dermatology • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Treatment and Outcome of ATL Diagnosed in 2021 to 2023 By the Kagoshima ATL Registry (ASH 2024) - "Among them, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone), VCAP-AMP-VECP (VCAP : vincristine, cyclophosphamide, doxorubicin, and prednisolone, AMP : doxorubicin, ranimustine, and prednisolone, and VECP : vindesine, etoposide, carboplatin, and prednisolone), any chemotherapy by cytotoxic agents combined with mogamulizumab (Moga+CTx), and CHP therapy combined with brentuximab vedotin (BV-CHP) were performed in 30.0 %, 28.3 %, 28.3 %, and 13.4% of patients, respectively. BV or Moga with or without CTx were most frequently used in the second-line treatment (n=81). This registration is expected to provide real-world data of ATL by regional registry in one of the world's most endemic area in HTLV-1 under the circumstances of the decreasing of HTLV-1 infected individuals in younger people and recent Introduction of novel therapeutic agents including tucidinostat and valemetostat in Japan."

Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

scRNA-seq reveals anti-lymphoma immune responses in mogamulizumab-associated skin eruptions (ISDS 2025) - "Our study provides novel insights into molecular properties of residual malignant clones within MAR that appear silenced, surrounded by a putatively anti-tumor immune response."

IO biomarker • Adult T-Cell Leukemia-Lymphoma • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Leukemia • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CCR4 • CCR7 • FKBP5 • FOXP3 • GZMA • MMP2 • RUNX3 • TIGIT • TIMP2