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

LACUTAMAB IN PATIENTS WITH RELAPSED AND REFRACTORY SéZARY SYNDROME: LONG TERM FOLLOW-UP FROM THE TELLOMAK PHASE 2 TRIAL (ICML 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 • Lymphoma • Sezary Syndrome • KIR3DL2

ONGOING PHASE 2, OPEN-LABEL, MULTICENTER, SINGLE-ARM STUDY ASSESSING AN EVERY-4-WEEK DOSING SCHEDULE OF MOGAMULIZUMAB IN CUTANEOUS T-CELL LYMPHOMA: PRELIMINARY RESULTS (ICML 2025) - P2 | "In the phase 3 MAVORIC study (N = 372), mogamulizumab, given 1 mg/kg weekly in cycle (C) 1 and then biweekly (Q2W), demonstrated superior efficacy versus vorinostat and a manageable safety profile. Preliminary results showed a promising safety profile and response rates of 2 mg/kg Q4W mogamulizumab."

Clinical • P2 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD7 • DPP4

TOTAL SKIN ELECTRON BEAM THERAPY FOR MYCOSIS FUNGOIDES IN THE MODERN ERA OF TSEBT DOSE REDUCTION AND DIVERSIFIED SYSTEMIC THERAPY (ICML 2025) - "26% (n = 28) received concurrent systemic therapy with TSEBT (Bexarotene: n = 17; Mogamulizumab: n = 5). TSEBT is effective for MF/SS, even in chemorefractory and advanced disease, and response does not differ by systemic therapy history. Response duration is limited but appears more durable among patients who received higher dose regimens. Further work is needed to determine predictors of TSEBT response and the effects on quality of life."

Cutaneous T-cell Lymphoma • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome

NOVEL CTCL RISK STRATIFIER INTEGRATING LYMPH NODE VOLUMETRICS AND mSWAT TO PREDICT SURVIVAL AND THERAPY RESPONSE (ICML 2025) - " The patient cohort included 262 patients enrolled in the landmark phase 3 clinical trial testing mogamulizumab versus vorinostat in previously treated CTCL (MAVORIC). This study highlights the limitations of current unidimensional lymph node measurements and demonstrates the value of these novel techniques. Volumetric measurements provide a powerful static predictor of survival and kinetic modeling adds a dynamic layer that can guide early treatment decisions and potentially predict lymph node involvement."

Cutaneous T-cell Lymphoma • Lymphoma

Classical and biological treatments in mycosis fungoides/Sézary syndrome. New horizons in oncodermatology. (PubMed, Postepy Dermatol Alergol) - "This might integrate biologic response agents like bexarotene, histone deacetylase inhibitors such as romidepsin, and specialized monoclonal antibodies or conjugates, notably mogamulizumab and brentuximab vedotin. The high-frequency ultrasound seems to be a useful tool for monitoring infiltration of the skin. Moreover, ongoing studies are investigating novel therapeutic agents that may demonstrate efficacy in MF/SS."

Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: John Reneau | Trial completion date: Apr 2025 ➔ Jan 2026 | Trial primary completion date: Apr 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Adult T-Cell Leukemia-Lymphoma • B Cell Lymphoma • Cutaneous T-cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

When Thyroiditis Meets Grave's: Untangling the Mystery of Atypical Hyperthyroidism (ENDO 2025) - "This case highlights the challenges of hyperthyroidism in a patient lacking classic features of either condition.Case PresentationA 50-year-old woman with cutaneous T-cell non-Hodgkin lymphoma (in remission, treated with mogamulizumab since 2020, currently on weekly therapy), untreated subclinical hyperthyroidism, and hypertension presented with fatigue, weakness, and a viral illness 8 weeks prior.Initial evaluation revealed undetectable TSH (6.0 ng/dL, and elevated C-reactive protein (CRP) at 6.80 mg/dL, consistent with thyrotoxicosis...However, the elevated TRAbs suggested underlying Graves' disease, prompting methimazole initiation.DiscussionDistinguishing SAT from Graves' disease requires careful integration of clinical, laboratory, and imaging findings:SAT: Low iodine uptake, elevated inflammatory markers (e.g., CRP), preceding viral illness, and normal or decreased vascularity on Doppler ultrasound.Graves' disease: High iodine uptake, positive TRAbs,..."

Cardiovascular • Cutaneous T-cell Lymphoma • Endocrine Disorders • Fatigue • Grave’s Disease • Hematological Malignancies • Hypertension • Immunology • Infectious Disease • Lymphoma • Musculoskeletal Pain • Non-Hodgkin’s Lymphoma • Oncology • Pain • T Cell Non-Hodgkin Lymphoma • CRP

Race, sex, and survival disparities in mycosis fungoides and Sézary syndrome: A SEER8 database analysis (1975–2021). (ASCO 2025) - "For MF, DSS improved after the late 1990s, reflecting advances like interferon and Bexarotene, with the most notable gains in 5-year DSS observed after 2010. For SS, OS and DSS have significantly increased since 2010, likely due to introduction of targeted therapies like mogamulizumab... This study highlights racial and sex-based survival disparities in MF and SS, with NHB males facing worse outcomes. We hypothesize that variations in the genetic landscape across races contribute to outcome differences. Our future research will incorporate institutional data and cancer somatic mutation data to explore the causes and develop targeted interventions to reduce disparities in underserved populations."

Cutaneous T-cell Lymphoma • Dermatology • Mycosis Fungoides • Oncology • Sezary Syndrome

Efficacy and manageable toxicity of mogamulizumab in a real-world North American cohort of adult T-cell leukemia/lymphoma (ATLL). (ASCO 2025) - "Our findings highlight the efficacy and tolerability of mogamulizumab in a real-world NA-ATLL cohort, showing improved survival outcomes compared to historical controls. These results support the inclusion of mogamulizumab in the treatment paradigm for heavily pre-treated ATLL patients. Larger prospective studies are warranted to re-explore its potential as monotherapy or in combination regimens in real world settings."

Clinical • IO biomarker • Real-world • Real-world evidence • Adult T-Cell Leukemia-Lymphoma • Cutaneous T-cell Lymphoma • Fatigue • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CCR4 • CD4

Black patients with cutaneous T-cell lymphoma (CTCL) and their likelihood to receive novel agents: A retrospective cohort analysis. (ASCO 2025) - "The introduction of novel therapies such as mogamulizumab and brentuximab vedotin (BV) for the treatment of CTCL have demonstrated improved survival compared to standard therapies...Systemic therapies were divided into three groups: standard chemotherapy (single agent or multi agent), biologics (interferon, retinoids, extracorporeal photopheresis, and oral methotrexate), and novel agents (mogamulizumab, BV, and clinical trials)... Receipt of novel agents was associated with improved survival. Black patients were less likely to receive novel agents when matched for age and disease stage. These findings suggest that treatment patterns, such as the receipt of novel agents, could play a role in the racial differences in clinical outcomes in CTCL."

Retrospective data • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

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

“Based on the available data and the Rapporteur’s assessment, PRAC agreed that the product information should be updated30 to add granuloma as undesirable effect with a frequency ‘not known’. PRAC also endorsed the classification of granuloma as a nonimportant identified risk in context of the PSUR” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 7 – 10 Apr 2025

PRAC • Cutaneous T-cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Comparative outcomes following treatment with mogamulizumab versus brentuximab vedotin for mycosis fungoides or Sézary syndrome (SID 2025) - "However, there was an increased risk of lymphopenia (HR, 1.50; 95% CI, 1.14-1.97; P=.008) and dermatitis (HR, 1.65; 95% CI 1.09-2.50; P=.03) with mogamulizumab. Our data suggest a reduced risk of hospitalization and serious adverse events in MF/SS patients treated with mogamulizumab compared to brentuximab vedotin, possibly related to off-target effects associated with the cytotoxic agent in brentuximab vedotin."

Late-breaking abstract • Cardiovascular • Cutaneous T-cell Lymphoma • Dermatitis • Dermatology • Hematological Disorders • Immunology • Infectious Disease • Mycosis Fungoides • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pain • Respiratory Diseases • Septic Shock • Sezary Syndrome • CCR4 • TNFRSF8

A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: City of Hope Medical Center

New trial • Cutaneous T-cell Lymphoma • Dermatology • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome

Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: May 2025 ➔ Jan 2026 | Trial primary completion date: May 2025 ➔ Jan 2026

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

Novel and recurrent histopathologic patterns of mogamulizumab-associated rash: diagnostic implications and insights for accurate diagnosis. (PubMed, J Dtsch Dermatol Ges) - "MAR presents a range of histological patterns that mimic other conditions, underscoring the importance of careful histopathological and immunohistochemical analysis and clinicopathological correlation for accurate diagnosis and management."

Journal • Acne Vulgaris • Dermatitis • Dermatology • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD123 • CD7 • CD8 • IL3RA

Single-cell RNA sequencing characterization of mogamulizumab-associated drug rash in cutaneous lymphoma patients (SID 2025) - "Within polyclonal bystander T cells, we found decreased levels of the exhaustion marker TIGIT in MAR compared to eCTCL, potentially reflecting a more tumor-permissive microenvironment in the latter. In sum, our study provides insights into molecular properties of residual malignant clones within MAR, which show an overall attenuated phenotype."

Clinical • IO biomarker • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • CCR4 • CCR7 • CRLF2 • CXCL13 • FOXP3 • KIR3DL2 • TIGIT • TSLP

Mogamulizumab induced lymph node enlargement mimicking mycosis fungoides progression. (PubMed, Br J Dermatol) - No abstract available

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

REAL-LIFE EXPERIENCE WITH MOGAMULIZUMAB IN PRIMARY CUTANEOUS T-CELL LYMPHOMA: A SINGLE-CENTER RETROSPECTIVE STUDY (EHA 2025) - "Our real-life experience confirmed the efficacy and safety of Mogalizumab as already report in registrative "Mavoric trial". Mogamulizumab represents a good choice in the management of relapsed/refractory disease, especially in the context of Sezary syndrome. Furthermore, the efficacy profile allows its use even in patients with low performance status."

Retrospective data • Bone Marrow Transplantation • Breast Cancer • Cutaneous T-cell Lymphoma • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • Septic Shock • Sezary Syndrome • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CCR4

INFECTIOUS COMPLICATIONS OF AGENTS USED IN T-CELL LYMPHOMAS: A DISPROPORTIONALITY ANALYSIS USING THE FAERS DATABASE (EHA 2025) - "The public dashboard of FAERS was queried for reports of infections due to herpes simplex virus (HSV), varicella zoster virus (VZV), cytomegalovirus (CMV), pneumocystis jiroveci (PJP) and cases of hepatitis B (HepB) reactivation and neutropenia associated with mogamulizumab, brentuximab vedotin, vorinostat, romidepsin, praletexate, methotrexate, peginterferon alpha-2a (PEG-IFN alfa-2a) and alemtuzumab when used for the indication of any T-cell lymphoma. Analysis of the FAERS database revealed variability in the reported infectious complications of commonly used agents for TCLs. Among all agents, alemtuzumab had the highest RORs for all infections while vorinostat had statistically significant RORs only for VZV-related infections and neutropenia. Romidepsin, which is a histone deacetylase inhibitor like vorinostat, had RORs that were unexpectedly higher than vorinostat and were comparable with other agents for CMV, HSV and PJP-related infections and neutropenia."

Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hepatitis B • Hepatology • Herpes Simplex • Herpes Zoster • Infectious Disease • Lymphoma • Neutropenia • Oncology • T Cell Non-Hodgkin Lymphoma • Varicella Zoster

REAL-WORLD EVIDENCE ON MOGAMULIZUMAB FOR SÉZARY SYNDROME AND MYCOSIS FUNGOIDES IN PATIENTS AGED 75 AND OLDER. (EHA 2025) - "Its efficacy was established in the open-label, phase 3 MAVORIC trial, which compared mogamulizumab to vorinostat and included patients with a median age of 64 years. This real-life study has demonstrated the efficacy and favorable safety profile of mogamulizumab in elderly patients over 75 years old, without a significant increase in serious adverse events leading to treatment discontinuation."

Clinical • HEOR • Real-world • Real-world evidence • Anemia • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Mycosis Fungoides • Oncology • Sezary Syndrome • Thrombocytopenia

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

Peripheral T- and natural killer-cell lymphomas: ESMO–EHA Clinical Practice Guideline for diagnosis, treatment and follow-up (ESMO.org) - "r/r ALK-positive ALCL- BV is recommended in patients who did not receive first-line BV or those with late relapse after an initial response [III, A]; For patients refractory to BV, ALK inhibitors such as crizotinib (EMA and FDA approved in children and young adults), alectinib (not EMA or FDA approved), brigatinib (not EMA or FDA approved) or ceritinib (not EMA or FDA approved) should be considered [III, A]. ChT (e.g. ICE, DHAP or IVAC–MTX) is also an option [III, B]...r/r ENKTCL- If available, an anti-PD-1 antibody such as pembrolizumab (not EMA or FDA approved) or nivolumab (not EMA or FDA approved) can be considered as monotherapy or in combination with gemcitabine and/or L-asparaginase or crisantaspase [III, B]...r/r T-PLL- Alemtuzumab–pentostatin is recommended after a treatment-free period of ≥6 months in patients who still have CD52-postive tumour cells [III, A; not EMA or FDA approved]."

Clinical guideline • Anaplastic Large Cell Lymphoma • Extranodal Natural Killer/T-cell Lymphoma • Peripheral T-cell Lymphoma

Selecting appropriate therapy for cutaneous T-cell lymphomas (CTCLs): recent advances and the unmet need. (PubMed, Expert Opin Pharmacother) - No abstract available

Journal • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

“Update of section 4.8 of the SmPC in order to add 'granuloma' to the list of adverse drug reactions (ADRs) with frequency 'unknown', based on post marketing data; the Package Leaflet is updated accordingly” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 7 - 10 Apr 2025: “For adoption of PRAC Assessment Report”

PRAC • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology