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

A phase 2 Trial of CHOP with Anti-CCR4 Antibody Mogamulizumab for older Patients with Adult T-Cell Leukemia/Lymphoma. (PubMed, Blood) - "Moga-CHOP is now considered a preferable first-line treatment for these patients. Clinical Trial Identifier: jRCTs041180130."

IO biomarker • Journal • P2 data • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CCR4

Phase I Study of Mogamulizumab in Combination with Pembrolizumab in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma-A National Cancer Institute Experimental Therapeutics Clinical Trials Network (NCI-ETCTN) Trial. (PubMed, Cancers (Basel)) - P2 | "The remaining patient experienced stress cardiomyopathy during the third cycle and was taken off the study. In striking difference to the observation in solid malignancies, the combination of mogamulizumab with pembrolizumab was associated with low tolerability and suspected hyper-progression in patients with lymphoma."

Journal • P1 data • B Cell Lymphoma • Cardiomyopathy • Cardiovascular • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma

Efficacy and Safety of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302 (ASH 2022) - P3 | "Approximately half (34 of 69; 49.3%) of patients had prior exposure to 1 or more FDA-approved targeted therapeutics: romidepsin, brentuximab, or mogamulizumab. In study 302, E7777 at a dose of 9 mcg/kg/day demonstrated clinical efficacy and clinically meaningful benefit in heavily pre-treated patients with relapsed/refractory CTCL. The ORR of 36.2% per IRC (42.3% by investigator assessment) showed that a substantial proportion of these heavily pretreated patients experienced clinical benefit after E7777 treatment similar to ONTAK. The observed tumor responses were rapid, durable, and deep."

Clinical • Cutaneous T-cell Lymphoma • Dermatology • Fatigue • Hematological Malignancies • Hepatology • Infectious Disease • Lymphoma • Oncology • Pruritus • T Cell Non-Hodgkin Lymphoma • IL2

A historical review of mycosis fungoides: from Alibert to mogamulizumab. (PubMed, Skin Health Dis) - "Developments in immunohistochemistry for the T-cell receptor gene in the 1990s improved the diagnosis of CTCL; however, diagnosis is still challenging. Advanced MF therapies have evolved from cytotoxic chemotherapy to novel monoclonal antibodies such as mogamulizumab, targeting proteins on T-cell lymphoma cells."

Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Infectious Disease • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • Skin Cancer • Solid Tumor • T Cell Non-Hodgkin Lymphoma

Chemokine Networks in Cutaneous T Cell Lymphoma: Tumor Microenvironment Remodeling and Therapeutic Targets. (PubMed, Curr Issues Mol Biol) - "Therapeutically, agents targeting chemokine pathways, most notably the CCR4 monoclonal antibody Mogamulizumab, have demonstrated clinical efficacy, while emerging inhibitors of CCR6, CCR5, and CXCR4 offer promising avenues for intervention. We further highlight how recent single-cell and other high-dimensional omics studies refine cell-type-specific chemokine sources and receptor expression, enabling more precise mapping of chemokine-driven intercellular communication programs in CTCL TME remodeling and better prioritization of therapeutic targets and biomarkers."

Biomarker • IO biomarker • Journal • Review • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CCL19 • CCL2 • CCL21 • CCL22 • CCL27 • CCR10 • CCR2 • CCR4 • CCR6 • CCR7 • CCR8 • CD4 • CXCL12 • CXCR3 • CXCR4 • CXCR5

First-in-human phase 1 study of KHK2455 monotherapy and in combination with mogamulizumab in patients with advanced solid tumors. (PubMed, Cancer) - P1 | "KHK2455 + mogamulizumab was safe and well tolerated with manageable toxicities, and resulted in dose-dependent suppression of IDO1 activity; signals of antitumor activity were observed."

Journal • Monotherapy • P1 data • Brain Cancer • Esophageal Cancer • Glioblastoma • Oncology • Solid Tumor • CCR4

Efficacy and tolerability of mogamulizumab in mycosis fungoides and Sézary Syndrome: a monocentric retrospective study (Front Oncol) - "Of the 12 patients treated, 8 had MF and 4 had SS. The median follow-up time was 29.9 months (range 2.8–68.6 months). Four patients discontinued mogamulizumab: 3 due to disease progression and 1 due to the development of breast cancer. Adverse events included MAR in 4 patients (33%) and colitis in 1 patient (6%). The observed median PFS after mogamulizumab therapy was 5.4 months, and the observed ORR was 50%. For all 12 patients, the median time to response (TTR) was 129 days."

Retrospective data • Mycosis Fungoides • Sezary Syndrome

Mogamulizumab versus investigator choice of chemotherapy regimen in relapsed/refractory adult T-cell leukemia/lymphoma. (PubMed, Haematologica) - P2 | "Investigator choice chemotherapy did not result in tumor response in this trial; however, mogamulizumab treatment resulted in 11% confirmed overall response rate, with a tolerable safety profile. This trial was registered at www.clinicaltrials.gov as NCT01626664."

Clinical • Journal • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Thrombocytopenia

Lacutamab in patients with relapsed and refractory Sézary syndrome: Long term follow-up from the TELLOMAK phase 2 trial. (ASCO 2025) - P2 | "The long term follow-up data from TELLOMAK study in a R/R SS population previously treated with 2 or more prior systemic therapies including mogamulizumab, confirm that lacutamab shows promising clinical activity with ORR 42.9% (95% CI 31.4-55.1) and median duration of response of 25.6 months (11.0, NE) and an overall favourable safety profile. These data support the further development of lacutamab in an effort to bring improved treatments to patients with SS."

Clinical • P2 data • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Sezary Syndrome • KIR3DL2

An Open-Label, Single-Arm, Phase 2 Trial of Valemetostat in Relapsed or Refractory Adult T-Cell Leukemia/Lymphoma. (PubMed, Blood) - P2 | "Twenty-five patients (median age, 69.0) with a median of 3 prior lines of therapy were enrolled; 24 had prior mogamulizumab treatment. Grade ≥3 TEAEs included thrombocytopenia, anemia, lymphopenia, leukopenia, and neutropenia. Valemetostat demonstrated promising efficacy and tolerability in heavily pretreated patients, warranting further investigation in treating R/R ATL."

Journal • P2 data • Adult T-Cell Leukemia-Lymphoma • Alopecia • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • EZH2

Mogamulizumab-Associated Rash (MAR) Correlates with Longer Progression Free Survival in Cutaneous T Cell Lymphoma (CTCL) (ASH 2022) - "In the Phase III MAVORIC trial comparing mogamulizumab to vorinostat, mogamulizumab-associated rash (MAR) was reported in 25% of patients (pts) and was more common in responders than in non-responders. The development of MAR in patients with CTCL is associated with higher rates of CR and ORR and significantly longer PFS and OS. CR/PR response in blood were associated with improved PFS. Additionally, 40% of patients who developed MAR and discontinued mogamulizumab had ongoing responses without additional systemic therapy."

IO biomarker • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CCR4

Lacutamab in Patients with Relapsed and Refractory Sèzary Syndrome: Results from the Tellomak Phase 2 Trial (ASH 2023) - P2 | "Conclusion In this SS cohort from the TELLOMAK study, our data confirm that lacutamab monotherapy shows promising clinical activity in a R/R population previously treated with 2 or more prior systemic therapies including mogamulizumab, and an overall favourable safety profile. Continued evaluation of this new targeted treatment option for patients with SS is warranted."

Clinical • P2 data • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • KIR3DL2

Sézary syndrome presenting as vitiligo-like leukoderma with response and repigmentation to mogamulizumab and extracorporeal photopheresis. (PubMed, JAAD Case Rep) - No abstract available

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Immunology • Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • Vitiligo

Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas (clinicaltrials.gov) - P2 | N=23 | Recruiting | Sponsor: University of Michigan Rogel Cancer Center | Trial completion date: Dec 2026 ➔ Apr 2027 | Trial primary completion date: Dec 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Mogamulizumab plus etoposide in the management of mycosis fungoides with blood involvement: a case report. (PubMed, Ther Adv Hematol) - "The patient achieved a partial response with methotrexate but discontinued after ~12 months due to elevated transaminases. Following treatment with bexarotene then gemcitabine, CHOP chemotherapy was initiated in December 2019, but, after a period of partial skin response, the patient relapsed with progression of skin lesions...Disease progression in the skin occurred in December 2020; mogamulizumab was continued, and the patient achieved remission with the addition of etoposide and prednisone in August 2021...In October 2022, the patient was diagnosed with large cell CD30+ transformation, and the therapeutic approach was changed to extracorporeal photopheresis, brentuximab vedotin, and topical steroids. The patient died in February 2023 due to sepsis. Our experience adds to the limited evidence that mogamulizumab may be continued in combination with etoposide following disease progression in patients with MF with blood involvement; however, more research is needed on the..."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mycosis Fungoides • Oncology • Pain • Septic Shock • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Use of mogamulizumab in cutaneous T-cell lymphomas among people living with HIV: insights from a nationwide French cohort. (PubMed, Br J Dermatol) - No abstract available

Journal • Cutaneous T-cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

FIL_MOGA: Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma (clinicaltrials.gov) - P=N/A | N=100 | Completed | Sponsor: Fondazione Italiana Linfomi - ETS | Recruiting ➔ Completed | N=150 ➔ 100

Enrollment change • Real-world evidence • Trial completion • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for T-Cell Lymphomas, Version 1.2026. (NCCN)

NCCN guideline • Extranodal Natural Killer/T-cell Lymphoma • Peripheral T-cell Lymphoma • T-Cell Large Granular Lymphocyte Leukemia

Anti-HER2×CCR4 bispecific antibody enhances antitumor immunity in advanced HER2-positive tumors by chemotaxis blockade and depletion of tumor-associated Tregs, without inducing systemic toxicity. (PubMed, J Immunother Cancer) - "XL-11 mediates potent antitumor immunity in advanced HER2+ tumors while avoiding reducing Tregs throughout the body. XL-11 also acts synergistically with anti-PD-1 therapy, and exhibits favorable stability and PK supporting clinical translation. This work advances Treg-targeted therapies in HER2+ tumors and overcomes the therapeutic limitations of mogamulizumab."

Journal • Breast Cancer • Gastric Cancer • Hematological Disorders • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CCR4 • CD8 • PD-L1

Rapidly Progressing CD8-negative Hypopigmented Mycosis Fungoides in Adult Caucasian Male with Good Response to Mogamulizumab. (PubMed, Acta Derm Venereol) - "The lesions are usually asymptomatic and respond well to topical treat-ment or phototherapy. This article presents a case of an adult Caucasian male with a rare variant of CD8-negativeh hypopigmented mycosis fungoides, with a rapid progression to erythrodermic lesions, failure of standard treatment, and a good response to mogamulizumab."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Mycosis Fungoides • Oncology

Phototherapy and Mogamulizumab in Early Stage MF (PLIGHT) (clinicaltrials.gov) - P1 | N=20 | Suspended | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Suspended

Trial suspension • Cutaneous T-cell Lymphoma • Dermatology • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • CD7

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