Lacutamab in patients with relapsed and refractory Sézary syndrome: Long term follow-up from the TELLOMAK phase 2 trial.

作者：Pierluigi Porcu, Martine Bagot, Youn H. Kim, Caroline Ram‐Wolff, Larisa J. Geskin, Pablo L. Ortiz‐Romero, Ellen J. Kim, Neha Mehta–Shah, O. Dereure, Saskia Ingen-Housz-Oro, Marie Beylot-Barry, Stéphane Dalle, Eric D. Jacobsen, Frederick Lansigan, Lubomir Sokol, Hélène Moins Teisserenc, Pier Luigi Zinzani, Julien Viotti, Christine Paiva, A. Boyer Chammard · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.2522 · 被引用次数：4 · 研究领域：Cutaneous lymphoproliferative disorders research、Infectious Diseases and Mycology、Toxin Mechanisms and Immunotoxins

2522 Background: Sézary syndrome (SS) is a rare and aggressive cutaneous T-cell lymphoma, which commonly expresses KIR3DL2, a killer immunoglobulin-like receptor, reported in ≥ 85% of patients. SS is characterized by erythroderma, significant blood involvement, lymphadenopathy and poor prognosis (10-20% 5-year survival). Lacutamab is a first-in-class monoclonal antibody designed to specifically deplete KIR3DL2-expressing cells via antibody-dependent cell-cytotoxicity and phagocytosis. Methods: TELLOMAK is an international, Phase 2 trial with multiple cohorts (NCT03902184). We report here long term follow-up results from Cohort 1, evaluating lacutamab in patients with relapsed/refractory (R/R) SS after at least 2 prior systemic therapies including mogamulizumab. Lacutamab 750 mg is administered until progression or unacceptable toxicity. Primary endpoint was Objective Response Rate (ORR) based on the evaluation of 4 compartments: skin, blood, lymph nodes and viscera according to the International Consensus criteria Olsen 2011. Secondary endpoints included but were not limited to duration of response (DOR), progression free survival (PFS), safety, and quality of life assessments. Results: As of October 17, 2024, recruitment was completed with 63 SS patients enrolled. Median age was 69 years (range: 42-86), the median prior lines of systemic therapies were 5.0 (range: 2-13), 65.1% and 34.9 % patients had stage IVA1 and stage IVA2 at baseline respectively, all patients had blood ...