Overview

• Topline phase 3 BRUIN CLL-313 results show pirtobrutinib significantly prolonged progression-free survival versus bendamustine plus rituximab in untreated CLL/SLL without 17p deletions.
• Overall survival favored pirtobrutinib at this interim readout, but the data are not yet mature, with the primary OS analysis planned for 2026.
• The open-label, global trial enrolled 282 patients randomized 1:1 to pirtobrutinib 200 mg daily or chemoimmunotherapy, with crossover to pirtobrutinib permitted upon progression.
• Lilly reported a safety profile consistent with prior pirtobrutinib studies, and detailed efficacy and safety data will be presented at a medical congress and submitted for peer review.
• Results will support planned global submissions to expand Jaypirca’s label into earlier lines, building on prior BRUIN studies and its existing approval after at least two prior therapies.