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Results from the BRUIN CLL-314 study comparing Jaypirca (pirtobrutinib) to Imbruvica (ibrutinib) – the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve CLL/SLL patients – will be presented as an oral presentation
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Results from the Phase 3 BRUIN CLL-313 study of pirtobrutinib in patients with treatment-naïve CLL/SLL will be featured as a late-breaking oral presentation
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Both BRUIN CLL-314 and BRUIN CLL-313 were selected to be part of the official ASH press program
INDIANAPOLIS, Nov. 24, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place Dec. 6-9 in Orlando, Florida.
Key data presentations for Jaypirca include:
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In an oral presentation, Lilly will share results from the BRUIN CLL-314 study, comparing pirtobrutinib to Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Lilly previously announced that pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05. BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients. These results were also selected to be highlighted in the ASH Annual Meeting press program session on Dec. 7.
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In a late-breaking oral presentation, Lilly will share results from the Phase 3 BRUIN CLL-313 study of pirtobrutinib versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL without del(17p). Lilly previously announced the study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival with pirtobrutinib compared to chemoimmunotherapy. These results were also selected to be highlighted in the ASH Annual Meeting press program session on Dec. 8.
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In other oral and poster presentations, Lilly will share additional data from the Phase 1/2 BRUIN study in patients with relapsed or refractory CLL, mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM). These long-term data include efficacy and safety results with approximately five years of follow-up.
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In an oral presentation, results will be shared from an investigator-initiated Phase 2 study of time-limited treatment with a combination of pirtobrutinib, venetoclax, and obinutuzumab in treatment-naïve CLL.
"Building on our previous announcements of positive topline results for the Phase 3 BRUIN CLL-313 and CLL-314 studies, we are excited to share the full results at ASH," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Collectively, data from across the pirtobrutinib development program and investigator-led studies reinforce the medicine's unique clinical profile and its potential role across treatment settings and B-cell malignancies."
About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.
Endnotes & References
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Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a Phase 1/2 study. Lancet. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5
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Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma. J Hematol Oncol. 2020;13(1):79. Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1
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Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies. J Hematol Oncol. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-021-01049-7