Study
| Randomised, double-blind, placebo-controlled phase 3 trial (SYMPATICO) |
| Relapsed or refractory mantle cell lymphoma (MCL) after 1-5 prior therapies |
| Ibrutinib 560 mg daily + Venetoclax ramp-up to 400 mg daily vs. Ibrutinib 560 mg daily + placebo |
Efficacy
| mPFS: 31.9 mos vs. 22.1 mos (ibrutinib-venetoclax vs. ibrutinib-placebo) (HR:0.65 [0.47-0.88]) |
| 24-mo PFS: 66% vs. 61% |
| mOS: NR vs. 15.4 mos in TP53-mutated patients |
Safety
| Grade ≥3 AEs: neutropenia (31% vs. 11%), thrombocytopenia (13% vs. 8%), pneumonia (12% vs. 11%) |
| Serious AEs: 60% vs. 60% |
| Treatment-related deaths: 2% vs. 2% (COVID-19, cardiac arrest, respiratory failure, pneumonia) |
Lancet Oncol 2025;26:200-13
http://doi.org/10.1016/S1470-2045(24)00048-7
Reviewed by Ulas D. Bayraktar, MD on Mar 2, 2025
