Overview
- In the intent-to-treat population, overall response rate was 87.0% with pirtobrutinib versus 78.5% with ibrutinib, meeting noninferiority and showing a numerical advantage (noninferiority P < .0001).
- Investigator-assessed progression-free survival favored pirtobrutinib at 18 months in the overall group, 86.9% versus 82.3% (HR 0.569; nominal P = .0034) at roughly 20–22 months’ median follow-up.
- In treatment-naive patients, early PFS separation was most pronounced at 18 months, 95.3% with pirtobrutinib versus 87.6% with ibrutinib (HR 0.239; nominal P = .0007), with higher but not statistically significant ORR (92.9% vs 85.8%).
- In the relapsed/refractory subgroup, pirtobrutinib produced a higher ORR than ibrutinib (84.0% vs 74.8%) while 18-month PFS differences were smaller and not statistically significant (81.7% vs 79.2%; HR 0.729).
- Context for practice includes the FDA’s recent full approval of pirtobrutinib for CLL/SLL after covalent BTK inhibitors and a separate final BRUIN analysis reporting an 81.6% ORR with durable benefit and a favorable safety profile in pretreated patients.