Fixed‐Duration Subcutaneous Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma: Pivotal Phase 2 Primary Analysis
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT Mosunetuzumab is approved as an intravenous (IV) formulation for relapsed/refractory (R/R) follicular lymphoma (FL) after ≥ 2 prior therapies. A subcutaneous (SC) formulation, aiming to improve patient safety and convenience, has been developed. We report the primary analysis of pharmacokinetics (PK), efficacy, and safety of mosunetuzumab SC ( N = 94; median follow‐up: 26.1 months) at the recommended Phase 2 dose (Cycle [C]1 Day [D]1: 5 mg; C1D8 and D15, and C2D1 onwards: 45 mg) in patients with R/R FL after ≥ 2 prior therapies, alongside data from a within‐study comparator cohort of mosunetuzumab IV in a similar patient population ( N = 90; median follow‐up: 22.5 months). The co‐primary PK endpoints (C trough and AUC) were met, demonstrating non‐inferior exposure of mosunetuzumab SC versus IV (observed C trough[C3] : geometric mean ratio [GMR] 1.39 [90% confidence interval (CI): 1.20–1.61]; AUC 0–84 : GMR 1.06 [90% CI: 0.92–1.21]). Mosunetuzumab SC efficacy was consistent with IV: overall response rate, 76.6% (95% CI: 66.7–84.7); complete response rate, 61.7% (95% CI: 51.1–71.5); median duration of complete response, 34.6 months (95% CI: 20.7–not evaluable [NE]); and median progression‐free survival, 23.7 months (95% CI: 14.6–NE). Mosunetuzumab SC demonstrated a favorable safety profile versus mosunetuzumab IV with a numerically lower rate (29.8% vs. 44.4%) and severity (grade ≥ 2: 9.6% vs. 18.9%) of cytokine release syndrome (CRS) events. Mosunetuzumab SC combines the benefits of short administration time, fixed‐duration treatment, outpatient accessibility, and low CRS rate, offering clinically meaningful improvements in patient convenience and safety. Trial Registration: www.clinicaltrials.gov : NCT02500407.
Source: American Journal of Hematology
DOI: 10.1002/ajh.70225
Authors: Nancy L. Bartlett, Laurie H. Sehn, Sarit Assouline, Pratyush Giri, John Kuruvilla, Stephen J. Schuster, Sung‐Soo Yoon, Keith Fay, Georg Hess, Martin Dreyling, Norma C. Gutierrez, Eva Cybulski, Fidelis Sabalvaro, Elicia Penuel, Vanda Teodoro, Samuel Tracy, Denison Kuruvilla, Joseph Chen, Volker Wiebking, Michael C. Wei, L. Elizabeth Budde
Institutions: Washington University in St. Louis, University of British Columbia, Jewish General Hospital, Royal Adelaide Hospital, Princess Margaret Cancer Centre, Abramson Cancer Center, University of Pennsylvania, Seoul National University Hospital, Royal North Shore Hospital, Johannes Gutenberg University Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Ludwig-Maximilians-Universität München, Universidad de Salamanca, Instituto de Investigación Biomédica de Salamanca, Centro de Investigación del Cáncer, Centro de Investigación Biomédica en Red de Cáncer, Instituto de Biología Molecular y Celular del Cáncer de Salamanca, Genentech, Roche (Switzerland), City Of Hope National Medical Center
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,450
Funders: F. Hoffmann-La Roche, Genentech
OpenAlex ID: W7139978085