Study
| Randomized, double-blind, phase 3 trial (ECHO, NCT02972840) |
| Previously untreated mantle cell lymphoma patients ≥65 years |
| Acalabrutinib + bendamustine + rituximab (ABR) vs. placebo + bendamustine + rituximab (PBR), with rituximab maintenance |
| |
Efficacy
| ORR: 91.0% vs. 88.0% |
| CR: 66.6% vs. 53.5% |
| mPFS: 66.4 mos vs. 49.6 mos (HR: 0.73 [0.57–0.94]; P = .0160) |
| mOS: Not reached in either arm (HR: 0.86 [0.65–1.13]; P = .27) |
| |
Safety
| Any Grade AEs: 99.7% vs. 99.0% |
| Grade ≥3 AEs: 88.9% vs. 88.2% |
| Common AEs (ABR vs. PBR): nausea (42.8% vs. 37.7%), neutropenia (40.1% vs. 41.4%), diarrhea (37.4% vs. 27.9%), COVID-19 (30.6% vs. 20.9%), headache (30.3% vs. 14.1%) |
| Atrial fibrillation/flutter: 6.7% vs. 4.4% |
| Infections grade ≥3: 41.1% vs. 34.0% (adjusted rate: 17.4 vs. 16.0 per 100 patient-years) |
| AE-related discontinuation: 43.1% vs. 31.4% |
| Grade 5 COVID-19 events: 9.4% vs. 6.7% |
J Clin Oncol 2025;43:1710-22
Wang M,Salek D,Belada D Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma
http://doi.org/10.1200/JCO-25-00690
Reviewed by Ulas D. Bayraktar, MD on May 4, 2025
