Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis

Introduction: Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections. This study assessed response to brentuximab vedotin in patients with MF in the phase III AL-CANZA study. Methods: Baseline CD30 levels and large-cell transformation (LCT) status were centrally reviewed in patients with previously-treated CD30-positive MF using >= 2 skin biopsies obtained at screening; eligible patients required >= 1 biopsy with >= 10% CD30 expression. Patients were categorised as CD30(min) < 10% (>= 1 biopsy with <10% CD30 expression), or CD30(min) >= 10% (all biopsies with >10% CD30 expression) and baseline LCT present or absent. Efficacy analyses were the proportion of patients with objective response lasting >= 4 months (ORR4) and progression-free survival (PFS). Results: Clinical activity with brentuximab vedotin was observed across all CD30 expression levels in patients with >= 1 biopsy showing >= 10% CD30 expression. Superior ORR4 was observed with brentuximab vedotin versus physician's choice in patients: with CD30(min) < 10% (40.9% versus 9 .5%), with CD30(min) >= 10% (57.1% versus 10.3%), with LCT (64.7% versus 17.6%) and without LCT (38.7% versus 6.5% ). Brentuximab vedotin improved median PFS versus physician's choice in patients: with CD30(min) < 10% (16.7 versus 2.3 months), with CD30(min) >= 10% (15.5 versus 3.9 months), with LCT (15.5 versus 2.8 months) and without LCT (16.1 versus 3.5 months). Safety profiles were generally comparable across subgroups. Conclusion: These exploratory analyses demonstrated that brentuximab vedotin improved rates of ORR4 and PFS versus physician's choice in patients with CD30-positive MF and >= 1 biopsy showing >= 10% CD30 expression, regardless of LCT status. (C) 2021 The Authors. Published by Elsevier Ltd.