Eli Lilly announces Phase 3 BRUIN CLL-314 met primary endpoint

Eli Lilly (LLY) and Company announced results from the Phase 3 BRUIN CLL-314 clinical trial evaluating Jaypirca, a non-covalent Bruton tyrosine kinase inhibitor, versus Imbruvica, a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who were treatment-naive or were BTK inhibitor-naive. Pirtobrutinib met its primary endpoint of non-inferiority on overall response rate compared to ibrutinib in the intent-to-treat population. Pirtobrutinib also had numerically higher ORR rates and, while immature, progression-free survival 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 in treatment-naive patients, the subgroup with the longest follow-up. The study achieved its primary endpoint demonstrating that pirtobrutinib was statistically non-inferior to ibrutinib in independent review committee-assessed ORR for the ITT population, and results numerically favored pirtobrutinib. The overall safety profile for patients treated with pirtobrutinib in BRUIN CLL-314 was similar to previously reported trials, and the most common treatment-emergent adverse events were similar between arms.