Core Insights - The BRUIN CLL-314 study demonstrated that pirtobrutinib (Jaypirca) achieved a higher overall response rate (ORR) of 87.0% compared to ibrutinib's 78.5%, meeting its primary endpoint of non-inferiority [1][4] - Pirtobrutinib showed a favorable trend in progression-free survival (PFS), with a 76% reduction in the risk of disease progression or death in treatment-naïve patients [1][5] - The study results will be published in the Journal of Clinical Oncology and presented at the 2025 American Society of Hematology Annual Meeting [1][2] Study Details - The BRUIN CLL-314 study was a Phase 3, randomized, open-label trial involving 662 patients, comparing pirtobrutinib to ibrutinib in treatment-naïve and BTK inhibitor-naïve patients [3][10] - The primary endpoint was ORR assessed by an independent review committee, with secondary endpoints including PFS, duration of response, and safety [10] Efficacy Results - Pirtobrutinib's ORR was statistically non-inferior to ibrutinib, with a nominal p-value of 0.0035 [4] - The efficacy results favored pirtobrutinib across all evaluated populations, including treatment-naïve and relapsed/refractory patients [4][5] Safety Profile - The overall safety profile of pirtobrutinib was similar to previous trials, with fewer treatment-emergent adverse events compared to ibrutinib [6][7] - Notable adverse events included lower rates of atrial fibrillation/flutter (2.4% vs. 13.5%) and hypertension (10.6% vs. 15.1%) with pirtobrutinib [7] Future Directions - Lilly plans to share additional results from the Phase 3 BRUIN CLL-313 study at the ASH Annual Meeting, further exploring pirtobrutinib's efficacy in treatment-naïve CLL/SLL patients [8]