Eli Lilly and Company (NYSE:LLY) is one of the best pharma stocks to invest in. On December 7,  Eli Lilly and Company (NYSE:LLY) announced results from the Phase 3 BRUIN CLL-314 clinical trial that was evaluating Jaypirca (pirtobrutinib) versus Imbruvica (ibrutinib) in patients living with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were either BTK inhibitor-naïve or treatment-naïve. Jaypirca is a non-covalent Bruton tyrosine kinase inhibitor, while Imbruvica is a covalent BTK ...

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]

Core 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]

Core Insights - Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), demonstrating non-inferiority in overall response rate (ORR) compared to Imbruvica (ibrutinib) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) [1][2][3] Group 1: Clinical Trial Results - The BRUIN CLL-314 trial is the first head-to-head Phase 3 study against a covalent BTK inhibitor that includes treatment-naïve patients, with a total enrollment of 650 patients [1][4] - The primary endpoint of non-inferiority on ORR was met, with pirtobrutinib showing a nominal P-value for superiority of less than 0.05 [1][4] - Progression-free survival (PFS) data is still immature but is trending in favor of pirtobrutinib, with a formal analysis planned for the future [1][2] Group 2: Safety and Efficacy - The overall safety profile of pirtobrutinib in the trial was consistent with previous studies, and detailed results will be presented at a medical congress later in 2025 [2][3] - In the treatment-naïve subpopulation (n=225), a pronounced PFS effect size was observed in favor of pirtobrutinib [2] Group 3: Future Developments - The results from BRUIN CLL-314 build on previously reported positive outcomes from the BRUIN Phase 1/2 trial and the Phase 3 BRUIN CLL-321 trial, which focused on post-covalent BTK inhibitor populations [3] - The BRUIN CLL-313 Phase 3 study is expected to read out later in 2025, and combined results will support regulatory submissions globally [3]