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Lilly's Jaypirca (pirtobrutinib) significantly extended progression-free survival when added to a venetoclax time-limited regimen in patients with previously treated CLL/SLL
Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Treatment in both study arms was administered for up to two years, after which patients do not take any CLL therapy unt
About this update from Eli Lilly And Company
[{"type":"text","content":"BRUIN CLL-322 is the first Phase 3 readout in CLL to utilize and outperform a venetoclax-containing control arm","length":111,"tagName":"p","attribs":{}},{"type":"text","content":"This trial predominantly enrolled a patient population previously treated with covalent BTK inhibitors, highly relevant to current practice ","length":139,"tagName":"p","attribs":{}},{"type":"text","content":"These results mark the fourth positive Phase 3 study of pirtobrutinib in CLL","length":76,"tagName":"p","attribs":{}},{"type":"text","content":"INDIANAPOLIS, April 13, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). 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 (PFS), as assessed by an independent review committee (IRC). Results were consistent across clinically relevant subgroups and regardless of whether patients were previously treated with a covalent BTK inhibitor.","length":1001,"tagName":"p"},{"type":"text","content":"Overall survival (OS), 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.","length":405,"tagName":"p"},{"type":"text","content":"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.","length":189,"tagName":"p"},{"type":"text","content":""BRUIN CLL-322 was an ambitious trial, building on an effective regi...