Time to next treatment in patients with previously treated cutaneous T-cell lymphoma (CTCL) receiving mogamulizumab or vorinostat: A MAVORIC post-hoc analysis.

Abstract

7539 Background: CTCLs are chronic skin malignancies, characterized by relapsing/remitting behavior and progressive resistance to treatments, with a reported median time to next treatment (TTNT; ie, systemic treatment excluding topical steroids) in mycosis fungoides (MF) and Sezary syndrome (SS) of 5.4 months (mo) (Hughes et al. Blood, 2015). The phase 3 MAVORIC study demonstrated mogamulizumab (MOGA) was superior to vorinostat (VORI) in progression-free survival (median 7.7 vs 3.1 mo, P<0.0001) and confirmed overall response rates (28% vs 4.8%, P<0.0001) in previously treated patients with MF/SS (Kim et al. Lancet Oncol 2018). This post-hoc analysis examines TTNT to further explore the patient clinical experience. Methods: Patients with MF/SS who were treated with ≥1 prior systemic therapy were randomized 1:1 to receive MOGA (1.0 mg/kg, administered once weekly for the first 28-day cycle, then on Days 1 and 15 of subsequent cycles) or oral VORI (400 mg daily). Patients on VORI were permitted to crossover to MOGA upon approval. TTNT was defined as time to any therapy excluding topical steroids or focal radiation. The length of TTNT was assessed overall and by disease stage grouping (IB/II and III/IV) and disease type (MF and SS). Results: Median TTNT for the full ITT population was longer with MOGA at 11 mo (95% CI, 8.8-12.6) compared to VORI at 3.5 mo and consistently longer for MOGA vs VORI across disease stage grouping or by disease type (Table). Conclusions: TTNT in MF/SS represents an additional measure of clinical benefit and disease control in patients who may have progressed based on strict protocol definitions of progression. This post hoc analysis showing a prolonged TTNT across disease stages and types supports a clinical benefit for MF and SS patients who receive MOGA. Clinical trial information: NCT01728805. [Table: see text]