Eli Lilly announces BRUIN CLL-322 trial met primary endpoint

Eli Lilly (LLY) announced topline results from the Phase 3 BRUIN CLL-322 trial of Jaypirca, a non-covalent Bruton tyrosine kinase inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Treatment in both study arms was administered for up to two years, after which patients do not take any CLL therapy until their disease progresses. The study met its primary endpoint, demonstrating that the addition of pirtobrutinib to venetoclax plus rituximab led to a statistically significant and clinically meaningful improvement in progression-free survival, as assessed by an independent review committee. Results were consistent across clinically relevant subgroups and regardless of whether patients were previously treated with a covalent BTK inhibitor. Overall survival, a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of the pirtobrutinib combination regimen. The overall safety profile of this regimen was consistent with the known safety profile of each medicine. Rates of adverse events were similar across the study arms, with low rates of treatment regimen discontinuations, also similar between arms. Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal. Lilly intends to submit these results to regulators later this year for a label expansion.