Eli Lilly and Company (NYSE: LLY) announced positive topline results from the Phase 3 BRUIN CLL-313 trial evaluating Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.
Jaypirca demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with standard chemoimmunotherapy (bendamustine plus rituximab). The effect size observed represents one of the most compelling outcomes ever reported for a single-agent BTK inhibitor in a frontline CLL study.
While overall survival (OS) data remain immature, early findings suggest a favorable trend for Jaypirca, with final OS analysis expected in 2026. Safety results were consistent with prior trials. Detailed findings will be presented at an upcoming medical congress and published in a peer-reviewed journal.
With BRUIN CLL-313 and the recently announced positive results from BRUIN CLL-314 (head-to-head vs. ibrutinib), Lilly plans to pursue global regulatory submissions later this year to expand Jaypirca’s label into earlier lines of therapy.
“These results are striking, showing strong efficacy across both PFS and OS endpoints,” said Jacob Van Naarden, EVP and President of Lilly Oncology. “Jaypirca continues to demonstrate its potential as a meaningful treatment option across multiple CLL/SLL settings.”
The BRUIN program now includes three positive Phase 3 trials (CLL-313, CLL-314, CLL-321), building on the foundation of the original BRUIN Phase 1/2 study.
🔗 About Jaypirca (pirtobrutinib):
Jaypirca is a highly selective, reversible BTK inhibitor approved in the U.S. for the treatment of adults with relapsed/refractory mantle cell lymphoma (MCL) and CLL/SLL who have received prior BTK and BCL-2 inhibitor therapies. Full prescribing information.
🔗 About Lilly:
Eli Lilly and Company has been pioneering medical innovation for nearly 150 years, with a focus on diabetes, obesity, Alzheimer’s, immune disorders, and oncology. Learn more at Lilly.com and Lilly Newsroom.
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