The final results from the German MINT study evaluating mogamulizumab in patients with mycosis fungoides and Sézary syndrome were recently presented at the European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) Annual Meeting 2026 in Berlin, Germany (Abstract O-024).
Study Background
Conducted as a multicentric, noninterventional, combined retro-prospective real-world study across 18 centers throughout Germany, MINT brought together cutaneous T-cell lymphoma (CTCL) specialists to evaluate treatment outcomes with mogamulizumab in a real-world setting, with time to next treatment as the study’s primary endpoint. The study captured a broad and heterogeneous patient population, including clinically relevant subgroups such as patients with large cell transformation and folliculotropic mycosis fungoides, and stratified by disease stage and mogamulizumab-associated rash status, providing insights that complement evidence generated through controlled clinical studies.
Mycosis fungoides and Sézary syndrome are forms of CTCL, a type of non-Hodgkin’s lymphoma that manifests on the skin, though the disease can also involve the blood, lymph nodes, and visceral organs. Symptoms can include persistent, itchy and scaly rashes, changes in skin color and patches, plaques and/or tumors. These visible and often difficult-to-hide symptoms can make everyday activities harder and significantly affect patients’ quality of life, including their work, relationships, and social lives; for some patients, the disease can progress to affect long-term survival.
“For patients living with [mycosis fungoides] and [Sézary syndrome], understanding how treatments perform outside the controlled setting of clinical trials is critically important. The final MINT results demonstrate meaningful clinical outcomes across a broad patient population treated in routine practice and highlight the value of collaborative real-world research in helping clinicians make informed treatment decisions,” said Chalid Assaf, MD, PhD, Director of the Department of Dermatology and Venereology, Helios Klinikum Krefeld, Health and Medical University DüsseldorfKrefeld, Germany.
Final Analysis
The final analysis included 109 patients, comprising 56 patients with mycosis fungoides and 53 patients with Sézary syndrome, with a median follow-up of 25.2 months. The majority of patients had advanced disease when they started treatment, with 83.5% at stage IIB or above. The study demonstrated durable treatment outcomes, reporting a median time to next treatment of 14.9 months, a best overall response rate of 62.4%, and an overall median progression-free survival of 20.2 months. Median overall survival was not estimable at the time of analysis due to the limited number of deaths observed, despite up to 71 months of follow-up in some cases.
Looking more closely at treatment response in clinically relevant patient subgroups, exploratory analyses reported best overall response rates of 54.5% in patients with large cell transformation (n = 11; 95% confidence interval [CI] = 23.4%–83.3%) and 50.0% in patients with folliculotropic mycosis fungoides (n=12; 95% CI = 21.1%–78.9%). Additional exploratory analyses by disease stage showed best overall response rates of 50% in patients with early-stage disease (n = 18; 95% CI = 26.0%–74.0%) and 64.8% in patients with advanced-stage disease (n = 91; 95% CI = 54.1%–74.6%). Disease control rate was also reported in patients with mogamulizumab-associated rash (n = 47), at 95.7%.
Time to next treatment is an important measure in real-world clinical practice as it reflects both disease control and the duration of clinical benefit before a patient requires an alternative treatment approach. The study reported a median time to next treatment of 12.0 months in patients with mycosis fungoides and 20.2 months in patients with Sézary syndrome. Patients also experienced improvements in quality of life, with median Skindex-29 scores improving by 38.5% from 49.1 at treatment initiation (n = 21) to 30.2 at month 12 (n = 7).
The investigators concluded that, in a real-world setting, mogamulizumab demonstrated a safety profile comparable to that observed in the pivotal phase III MAVORIC study, while providing clinical benefits in treatment response and quality of life for patients with mycosis fungoides and Sézary syndrome. Grade 3 or higher treatment-related adverse events were reported in 38.5% of patients, most commonly drug eruption and lymphopenia. Serious treatment-related adverse events leading to discontinuation occurred in 22.0% of patients.
