INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) announced positive results from the Phase 3 BRUIN CLL-322 clinical trial evaluating Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, in combination with venetoclax and rituximab versus venetoclax and rituximab alone in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The study met its primary endpoint of independent review committee (IRC)-assessed progression-free survival (PFS). Results showed that adding pirtobrutinib to the two-year venetoclax plus rituximab regimen reduced the risk of disease progression or death by 45%.
Overall survival (OS), a key secondary endpoint, was not yet mature at the time of this analysis. Final testing of OS superiority is planned for a future date. Another secondary endpoint, time to next treatment (TTNT), consistently favored the pirtobrutinib combination regimen.
The overall safety profile of the regimen was consistent with the known safety profiles of each medicine. Importantly, little additive toxicity was observed with the addition of pirtobrutinib to venetoclax and rituximab.
BRUIN CLL-322 is the first Phase 3 study to demonstrate superiority over a venetoclax-containing control arm in CLL. With the majority of patients previously treated with a covalent BTK inhibitor, the trial reflects current practice patterns and underscores the potential of pirtobrutinib in advancing treatment outcomes.
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