Eli Lilly and Company reported positive topline results from the Phase 3 BRUIN CLL-322 trial evaluating Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, in combination with venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The study compared a fixed-duration regimen of pirtobrutinib plus venetoclax and rituximab with venetoclax and rituximab alone, with treatment in both arms limited to two years, followed by observation until disease progression.
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with the pirtobrutinib-containing regimen, as assessed by an independent review committee. PFS benefit was consistent across clinically relevant subgroups, including patients with or without prior exposure to covalent BTK inhibitors. Overall survival, a key secondary endpoint, was not yet mature at the time of analysis but showed a favorable trend for the triplet regimen.
The safety profile of pirtobrutinib plus venetoclax and rituximab was consistent with the known profiles of the individual agents, with similar rates of adverse events and low, comparable discontinuation rates between treatment arms. Lilly plans to present detailed data at an upcoming medical congress, submit the results to a peer-reviewed journal, and file for regulatory label expansion later this year.
These findings add to a growing body of evidence from the BRUIN clinical program, including prior Phase 3 studies BRUIN CLL-321, BRUIN CLL-314, and BRUIN CLL-313, which have evaluated pirtobrutinib across post–covalent BTK inhibitor, head-to-head, and treatment-naïve CLL settings.
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