EHA 2026 | BRUIN CLL-322: Clinical Outcome Analysis Report

Abstract: EHA-7224 Short: LB5001 BRUIN CLL-322 (NCT04965493) is the first randomized Phase 3 trial to evaluate a non-covalent BTK inhibitor–based triplet regimen in previously treated CLL/SLL. With a data cutoff of February 2, 2026, and results presented at EHA 2026, the trial demonstrated that fixed-duration pirtobrutinib + venetoclax–rituximab (PVR) significantly improved progression-free survival over venetoclax–rituximab (VenR) alone, meeting its primary endpoint across all key subgroups. Overall survival data were not yet mature but trended in favor of PVR. This represents Lilly's fourth Phase 3 CLL win for pirtobrutinib (Jaypirca®) and positions PVR as a potential new standard of care in the relapsed/refractory setting.