BOVen as frontline therapy in older patients with MCL: Phase II preliminary results

During the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US, Anita Kumar presented preliminary results from a phase II trial (NCT03824483) evaluating the safety and efficacy of the combination of zanubrutinib + obinutuzumab + venetoclax (BOVen) as a frontline therapy in 50 older patients with mantle cell lymphoma (MCL). The primary endpoint was 3-year progression-free survival (PFS).

Key data: The overall metabolic response rate was 98% (complete metabolic response [CMR], 96%; partial metabolic response [PMR], 2%). At a median follow-up of 25 months, 2-year PFS was 86% (95% confidence interval [CI], 77–97), and 2-year overall survival (OS) was 92% (95% CI, 84–100). Measurable residual disease (MRD) negativity (undetectable MRD at 10⁻⁶ [uMRD6]) was achieved in 93% of patients (28/30) at the end of treatment (EoT). The regimen was well tolerated, with Grade ≥3 adverse events (AEs) occurring in 42% of patients.

Key learning: The MRD response-adapted BOVen triplet demonstrates promising efficacy in older patients with MCL, with high response rates and encouraging survival outcomes, supporting further investigation.