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Efficacy and safety of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent NHL: Results of the Phase III MabCute study

Hematological Oncology Jun 19, 2019

Rule S, et al. - Since rituximab (R)-chemotherapy (chemo) induction plus R maintenance (maint) is an established treatment for indolent NHL (iNHL), but the optimum duration of R maint is unknown, however, a subcutaneous (SC) form of R (R-SC) is now available, researchers tested the safety and effectiveness of prolonged R-SC maint after standard R-SC-based induction and maint in relapsed or refractory (R/R) iNHL patients in this randomised Phase III trial (MabCute). Participants in the study were patients aged ≥18 years with R/R CD20+ follicular lymphoma (grade [Gr] 1, 2 or 3a) or other iNHL. A total of 46 PFS from randomisation (PFSrand) events have been noted, corresponding to 36% of the 129 events needed to achieve 80% power. Due to the limited number of events observed, MabCute was unable to fully address the primary study endpoint of PFSrand. During prolonged maint, the R-SC safety profile was consistent with the known R-SC profile. Pneumonia was the most common serious adverse event.
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