Lilly(US:LLY) Prnewswire·2025-12-09 12:30Core Insights - The Phase 3 BRUIN CLL-313 trial demonstrated that Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 80% compared to bendamustine plus rituximab in treatment-naïve patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) without 17p deletions [1][3][4] Group 1: Clinical Trial Results - The trial enrolled 282 patients, randomized to receive either pirtobrutinib monotherapy or the BR regimen, with crossover allowed after disease progression [3][9] - At a median follow-up of 28.1 months, pirtobrutinib showed a significant improvement in progression-free survival (PFS) with a hazard ratio (HR) of 0.20 [4] - Overall survival (OS) data showed a trend favoring pirtobrutinib, with an HR of 0.257, despite over half of the BR group crossing over to pirtobrutinib after progression [5] Group 2: Safety Profile - The safety profile of pirtobrutinib was comparable to previous trials, with Grade 3 treatment-emergent adverse events (TEAEs) occurring in 40% of patients on pirtobrutinib versus 67.4% on BR [6] - Fewer adverse event-related dose reductions (3.6% vs. 31.1%) and discontinuations (4.3% vs. 15.2%) were observed with pirtobrutinib [6] - The incidence of atrial fibrillation/flutter was similar between both treatment groups, indicating a favorable safety profile for pirtobrutinib [6] Group 3: Future Prospects - The findings support the potential use of pirtobrutinib in treatment-naïve patients and highlight its unique position as a BTK inhibitor effective for both newly diagnosed and previously treated patients [7] - The company is submitting results from BRUIN CLL-313 and BRUIN CLL-314 to regulatory authorities to expand Jaypirca's label into earlier lines of therapy [8] - The company anticipates regulatory approvals for pirtobrutinib in earlier disease settings in the coming year, which could enhance treatment options for patients [7]