Dr Visco on RBAC Plus Venetoclax in High-Risk MCL - Episode 2

Dr Visco on the Efficacy and Safety of Venetoclax Plus RBAC in High-Risk MCL

October 23, 2025

Carlo Visco, MD, discussed patient characteristics, efficacy data, and safety findings from the FIL_V-RBAC study of venetoclax plus RBAC in MCL.

EP. 1: Dr Visco on the Design of the FIL_V-RBAC Trial of RBAC Plus Venetoclax in High-Risk MCL

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EP. 2: Dr Visco on the Efficacy and Safety of Venetoclax Plus RBAC in High-Risk MCL

EP. 3: Dr Visco on the Role of RBAC Dose Reductions for High-Risk MCL

EP. 4: Dr Visco on Unmet Needs for Patients With Mantle Cell Lymphoma

EP. 5: Dr Visco on Ongoing Research to Optimize Upfront MCL Therapy

“We could say from at the end of the study that venetoclax conferred a survival advantage when consolidating patients with high-risk features, specifically after 4 cycles of RBAC.”

Carlo Visco, MD, an associate professor of hematology in the Department of Medicine, coordinator of the Lymphoma Team in the Hematology and Bone Marrow Transplant Unit in the Section of Biomedical Innovation in the Department of Engineering for Innovative Medicine at the University of Verona, discussed key efficacy and safety outcomes from the phase 2 FIL_V-RBAC study (NCT03567876) investigating the addition of venetoclax (Venclexta) to bendamustine plus rituximab (Rituxan) and intermediate-dose cytarabine (RBAC) in patients with high-risk mantle cell lymphoma (MCL).

This single-arm multicenter study was conducted across 35 institutions in Italy. The study population consisted of treatment-naive patients who were at least 65 years of age and fit, or younger than 65 years of age but ineligible for high-dose chemotherapy.

Upon enrollment, patients were risk-stratified based on the presence of specific high-risk features: blastoid morphology, Ki-67 levels of at least 30%, p53 mutations, or 17p deletion. The overall patient cohort exhibited demographics typically observed in MCL studies, Visco stated. Most of the patients were male, and all patients enrolled in the study were White. Slightly fewer patients had a high-risk profile vs a low-risk profile, Visco noted.

The primary end point of the trial was the 2-year progression-free survival (PFS) rate for the patients with a high-risk disease profile. Notably, the 2-year PFS rate in this population satisfied the primary end point of the study, according to Visco.

Regarding toxicity, no unexpected adverse effects were observed when compared with the known toxicities of the individual agents used, Visco said. The RBAC regimen, particularly with cytarabine at 500 mg/m2, is widely known to be associated with hematological toxicities, which can be mitigated through dose reductions, he explained. The addition of venetoclax in the consolidation portion of the trial conferred only minor hematological toxicity, he concluded.