Fixed-Duration Subcutaneous Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma: Pivotal Phase 2 Primary Analysis - PubMed
3 hours ago
- #follicular lymphoma
- #subcutaneous mosunetuzumab
- #bispecific antibody
- Mosunetuzumab is approved as an intravenous (IV) treatment for relapsed/refractory (R/R) follicular lymphoma (FL) after ≥ 2 prior therapies.
- A subcutaneous (SC) formulation of mosunetuzumab has been developed to improve patient safety and convenience.
- The primary analysis compared pharmacokinetics (PK), efficacy, and safety of mosunetuzumab SC (N = 94) versus IV (N = 90) in R/R FL patients.
- Mosunetuzumab SC demonstrated non-inferior exposure compared to IV, meeting co-primary PK endpoints (Ctrough and AUC).
- Efficacy of mosunetuzumab SC was consistent with IV, with an overall response rate of 76.6% and complete response rate of 61.7%.
- Median duration of complete response was 34.6 months, and median progression-free survival was 23.7 months for mosunetuzumab SC.
- Mosunetuzumab SC showed a favorable safety profile with a lower rate (29.8% vs. 44.4%) and severity of cytokine release syndrome (CRS) events compared to IV.
- The SC formulation offers benefits like short administration time, fixed-duration treatment, outpatient accessibility, and low CRS rate.