Study
| Randomized, double-blind, placebo-controlled, multicenter trial (ECHO) |
| Previously untreated Mantle Cell Lymphoma (MCL) who were ineligible for transplant (N=598) |
| Acalabrutinib + R-Bendamustine x 6 => rituximab-acalabrutinib maintenance vs. R-Bendamustine + placebo x 6 => rituximab + placebo maintenance |
Efficacy
| ORR; 91% vs. 88% (BR + acalabrutinib vs. BR + placebo) |
| CR: 67% vs. 54% |
| mPFS 66.4 mos vs. 49.6 mos (HR: 0.73 [0.57 – 0.94]) |
Safety
| Grade >=3 AEs: Neuropenia (56% vs. 51%), Rash (12% vs. 3%), |
FDA Package Insert for Acalabrutinib
FDA FDA Package Insert for Acalabrutinib
http://www.ncbi.nlm.nih.gov/pubmed/0
Reviewed by Ulas D. Bayraktar, MD on Jan 19, 2025
