Lilly On Sunday, Announced Jaypirca Met Its Primary Endpoint In Phase 3 CLL/SLL Study Vs Imbruvica

Eli Lilly and Company (NYSE:LLY) today announced results from the Phase 3 BRUIN CLL-314 clinical trial evaluating Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve. Pirtobrutinib met its primary endpoint of non-inferiority on overall response rate (ORR) compared to ibrutinib (87.0% [95% CI, 82.90-90.44] versus 78.5% [95% CI, 73.73-82.85]; p<0.0001) in the intent-to-treat (ITT) population. Pirtobrutinib also had numerically higher ORR rates and, while immature, progression-free survival (PFS) was also trending in favor of pirtobrutinib compared to ibrutinib across all populations, including a 76% reduction in the risk of disease progression or death (HR=0.239 [95% CI, 0.098-0.586]) in treatment-naïve patients, the subgroup with the longest follow-up.

In addition to meeting the primary endpoint of non-inferiority for overall response rate (ORR) in the BRUIN CLL-314 study, pirtobrutinib achieved a numerically higher ORR of 87.0% compared to 78.5% for ibrutinib in the intent-to-treat (ITT) population

Progression-free survival data were immature but trended in favor of pirtobrutinib with a 43% reduction of the risk of disease progression or death in the ITT population, and the treatment-naïve subgroup, which had the longest follow up, showed a 76% reduction

These data will be simultaneously published in the Journal of Clinical Oncology and presented at the 2025 American Society of Hematology Annual Meeting and Exposition, as well as featured as part of the meeting's press program