Prnewswire·2025-11-24 17:00Core Insights - Eli Lilly and Company will present data from the BRUIN CLL-314 and BRUIN CLL-313 studies of Jaypirca (pirtobrutinib) at the 67th American Society of Hematology (ASH) Annual Meeting, highlighting its unique clinical profile and potential role in treating B-cell malignancies [1][2][3] Study Results - The BRUIN CLL-314 study is the first head-to-head Phase 3 trial comparing pirtobrutinib to Imbruvica (ibrutinib) in treatment-naïve CLL/SLL patients, showing non-inferiority in response rates with a nominal P-value for superiority < 0.05 [3] - The BRUIN CLL-313 study demonstrated a statistically significant improvement in progression-free survival for pirtobrutinib compared to chemoimmunotherapy in treatment-naïve CLL/SLL patients without del(17p) [3] Presentation Details - Key presentations include long-term data from the Phase 1/2 BRUIN study in relapsed or refractory CLL, mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM), with approximately five years of follow-up [2][3] - Additional presentations will cover real-world treatment patterns and outcomes of patients receiving covalent BTK inhibitors in China, as well as the efficacy of pirtobrutinib in various treatment settings [4][5] Drug Profile - Jaypirca is a non-covalent BTK inhibitor, highly selective for BTK, and is FDA-approved for treating CLL/SLL and MCL [5][6] - The drug is administered as a 200 mg oral dose once daily, with ongoing treatment until disease progression or unacceptable toxicity [5] Safety and Efficacy - Common adverse reactions in patients treated with Jaypirca include decreased neutrophil count (46%), decreased hemoglobin (39%), and fatigue (32%) [9][10] - Serious adverse reactions occurred in 56% of CLL/SLL patients, with pneumonia and COVID-19 being the most common [10]