MRD-driven initial therapy of acalabrutinib and lenalidomide plus rituximab or obinutuzumab for mantle cell lymphoma - PubMed
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- #mantle cell lymphoma
- #MRD-driven therapy
- #acalabrutinib
- Phase 2 study evaluates acalabrutinib and lenalidomide combined with rituximab (ALR) or obinutuzumab (ALO) for frontline MCL treatment.
- Primary objective: molecular complete response (CR) after 12 cycles, defined by Lugano criteria and undetectable MRD (<10-6).
- Secondary objectives include safety, responses, and survival; exploratory objectives involve tumor mutation profiles and cfDNA analysis.
- ALR cohort showed 100% ORR, 83% CR rate, and 67% molecular CR after 12 cycles; best molecular CR at 83%.
- 4-year OS and PFS for ALR were 91% and 76%, respectively; TP53 mutations adversely affected PFS.
- ALO cohort showed 90% ORR, CR, and molecular CR after induction; 2-year OS and PFS both at 100%.
- Longitudinal cfDNA analysis in ALR revealed clonal evolution during response and progression.
- Regimen is safe, active, and feasible as time-limited initial therapy for MCL, warranting further evaluation.