KEY TAKEAWAYS
- Phase III MabCute trial evaluated the efficacy of extended maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma who responded to initial induction.
- The primary aim was to assess investigator-assessed progression-free survival in the randomized population.
- Patients who responded to induction with rituximab plus chemotherapy and were still responding after up to 2 years’ initial maintenance were randomized to extended maintenance with subcutaneous rituximab or observation only.
- There were no new safety signals; however, adverse events were seen slightly more frequently with rituximab than with observation during extended maintenance.
In patients with indolent non-Hodgkin lymphoma, rituximab plus chemotherapy induction, followed by rituximab maintenance for up to 2 years, significantly improves progression-free survival over the long term. It is unclear if additional benefits can be gained from maintaining rituximab treatment for longer. 692 patients with relapsed or refractory indolent non-Hodgkin lymphoma were enrolled in the phase III MabCute study. Extended maintenance with subcutaneous rituximab (n=138) or observation only (n=138) was randomly assigned to patients who responded to induction with rituximab plus chemotherapy and were still responding after up to 2 years of initial maintenance.
An insufficient number of events (129 events were needed for 80% power at 5% significance if approximately 330 patients were randomized) prevented the primary endpoint of investigator-assessed progression-free survival in the randomized population from being addressed by the study’s conclusion. There were 46 events of progression during the study, 19 in the rituximab arm and 27 in the observation arm [(95% confidence interval: 0.37-1.53) P=0.410 by stratified log-rank test]. In neither treatment group, progression-free survival reached a median. There were no fresh safety signals; however, rituximab was associated with a slightly higher incidence of adverse events than an observation during prolonged maintenance. Patients with relapsed or refractory indolent non-Hodgkin lymphoma continue to benefit from rituximab maintenance for up to 2 years following a response to initial induction.
Source: https://pubmed.ncbi.nlm.nih.gov/34134469/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT01461928
Rule S, Barreto WG, Briones J, Carella AM, Casasnovas O, Pocock C, Wendtner CM, Zaja F, Robson S, MacGregor L, Tschopp RR, Nick S, Dreyling M. Efficacy and safety assessment of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results of the phase III MabCute study. Haematologica. 2022 Feb 1;107(2):500-509. doi: 10.3324/haematol.2020.274803. PMID: 34134469; PMCID: PMC8804572.
