Pirtobrutinib showed superior progression-free survival compared to bendamustine plus rituximab with a hazard ratio of 0.199. It was well tolerated with significantly fewer adverse events and lower discontinuation rates than the comparator arm.
Study
|
Randomized, open-label, global, phase III study [BRUIN CLL-313] |
| Treatment-naïve CLL/SLL without del-17p |
| Pirtobrutinib (n=141) vs Bendamustine+Rituximab (n=141)
|
Efficacy
|
ORR: 94% vs 81% (pirtobrutinib vs. R-benda) (p=0.0006) |
| 2yr PFS: 93% vs 71%(HR: 0.199 [0.107-0.367]) |
| 2yr OS: 97.8% vs 93%
|
Safety
|
Grade >=3 AE: Neutropenia (7.1% vs 34.8%) |
| AE-related dose reductions: 3.6% vs 31.1% |
| Treatment discontinuations: 4.3% vs 15.2%
|
J Clin Oncol Published online December 9, 2025
http://doi.org/10.1200/JCO-25-02380
Reviewed by Ulas D. Bayraktar, MD on Jan 21, 2026
