Fixed treatment duration mosunetuzumab continues to demonstrate clinically meaningful outcomes in patients with relapsed/refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies: 5-year follow-up of a pivotal Phase II study

作者：Elizabeth Budde, Laurie H. Sehn, Matthew J. Matasar, Stephen J. Schuster, Sarit Assouline, John Kuruvilla, Won Seog Kim, Chan Y. Cheah, Mazyar Shadman, Sascha Dietrich, Matthew Ku, Dima El‐Sharkawi, Norma C. Gutiérrez, Michael C. Wei, Shen Yin, Jason Sit, Samuel Tracy, Fidelis Sabalvaro, Elicia Peneul, Nancy L. Bartlett · 发表于：Blood · 年份：2025 · DOI：10.1182/blood-2025-5352 · 被引用次数：3 · 研究领域：CAR-T cell therapy research、Lymphoma Diagnosis and Treatment、Monoclonal and Polyclonal Antibodies Research

Abstract Background: Mosunetuzumab is the first FDA- and EMA-approved CD20xCD3 T-cell engaging bispecific antibody for the treatment of R/R FL after ≥2 prior lines of therapy. In a pivotal Phase II study (NCT02500407), fixed-duration mosunetuzumab demonstrated high response rates, durable remissions, and a manageable safety profile in patients with R/R FL (Budde et al. Lancet Oncol 2022; Shadman et al. ASH 2024; Cheah et al. EHA 2025). We report updated efficacy and safety data for mosunetuzumab in patients with R/R FL after a median follow-up of 5 years. Methods: Eligible patients with R/R FL Grade 1–3a and ≥2 prior therapies received intravenous mosunetuzumab for a fixed duration with step-up dosing in Cycle (C)1. Hospitalization was not mandatory. Patients with a complete response (CR) by C8 completed therapy with no additional cycles; patients with partial response or stable disease post C8 could continue treatment for up to 9 additional cycles (a total of 17 cycles). Efficacy analyses by investigator assessment (Cheson et al. 2007 criteria) included CR rate, overall response rate (ORR), duration of response (DOR), duration of CR (DOCR), progression-free survival (PFS), overall survival (OS) and time to next treatment (TTNT). Safety and tolerability were assessed by describing the incidence and severity of adverse events (AEs). After the AE reporting period (90 days after the last dose or start of new anti-lymphoma treatment), mosunetuzumab-related serious AEs were to be ...