INDIANAPOLIS, December, 2025 — Eli Lilly and Company (NYSE: LLY) today announced resultsfrom the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, versus bendamustine plus rituximab (BR), in treatment-naïvepatients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions. Pirtobrutinib met its primary endpoint demonstrating a reduction in the risk of disease progression or death by 80% (HR=0.20 [95% CI, 0.11-0.37]; p<0.0001).
These data will be highlighted in a late-breaking oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in Orlando, Florida and simultaneously published in the Journal of Clinical Oncology.
“The results from BRUIN CLL-313 show a significant effect size, among the most pronounced ever observed for a single agent BTK inhibitor in a front-line CLL study,” said Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland. “The magnitude of the progression-free survival benefit, early overall survival trend and safety profile observed in BRUIN CLL-313 offer highly compelling evidence for the potential role of pirtobrutinib in treatment-naïve CLL.”
BRUIN CLL-313 is the first prospective, randomized Phase 3 study examining the efficacy and safety of a non-covalent BTK inhibitor, pirtobrutinib, exclusively in patients with treatmentnaïve CLL/SLL. BRUIN CLL-313 enrolled 282 patients with previously untreated CLL/SLL without del(17p), who were randomized 1:1 to receive continuous pirtobrutinib monotherapy (n=141) or BR (n=141). Crossover to the pirtobrutinib arm was allowed after independent review committee (IRC)-confirmed disease progression. The efficacy results are based on a July 11, 2025, data cutoff.
At a median follow-up of 28.1 months, the primary endpoint of IRC-assessed progression-free survival (PFS) was significantly improved with pirtobrutinib compared to BR (HR=0.20 [95% CI, 0.11–0.37]; p<0.0001). PFS results favored pirtobrutinib across all pre‑specified subgroups, including those with high-risk molecular features such as TP53 mutations, complex karyotype, and unmutated IGHV, and was consistently observed among investigator assessments.
Overall survival (OS), a key secondary endpoint, remains immature, but a trend favoring pirtobrutinib was observed (HR=0.257 [95% CI, 0.070–0.934]; p=0.0261) despite over half (52.9%) of patients treated with BR crossing over to receive pirtobrutinib after IRC-confirmed disease progression. Final testing of OS superiority is planned at a future date.
The overall safety profile of patients treated with pirtobrutinib in BRUIN CLL-313 was similar to previously reported trials. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 40.0% of patients who received pirtobrutinib versus 67.4% with BR. Fewer adverse eventrelated dose reductions (3.6% versus 31.1%) and TEAE-related discontinuations (4.3% versus15.2%) were seen with pirtobrutinib versus BR. The incidence of all-grade and high-grade atrial fibrillation/flutter were similar between pirtobrutinib and BR, a notable finding as BR is not a regimen associated with increased risk of this side effect (1.4% versus 1.5% and 0.7% versus 0.8%, respectively).
“These findings support the potential use of pirtobrutinib in certain treatment-naïve patients and underscore its unique position as the only BTK inhibitor to show promise in treating both newly diagnosed patients with CLL or SLL and those who have progressed on a covalent BTK inhibitor,” said Jacob Van Naarden, executive vice president and president, Lilly Oncology.
“Alongside the recently presented BRUIN-CLL 314 results, we are excited about how collectively these data may advance the therapeutic landscape in treatment-naïve CLL and are hopeful we will receive regulatory approvals for pirtobrutinib in earlier disease settings sometime next year, further expanding treatment options for patients.” Lilly has begun submitting results from BRUIN CLL-313 and BRUIN CLL-314 studies to regulatory authorities with the goal of further expanding Jaypirca’s label into earlier lines of therapy. Lilly is studying Jaypirca in CLL/SLL in multiple Phase 3 studies. Details on the trials can be found by visiting clinicaltrials.gov.
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.
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Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly’s investment in a supercomputer, the potential abilities, performance, applications, and outcomes from AI and other initiatives and reflects Lilly’s current beliefs and expectations. The words “will”, “believe”, “plan”, “may”, “could”, “can”, and similar expressions are intended to identify forward-looking statements. However, as with any such undertaking, there are substantial risks and uncertainties in implementing technology and in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the supercomputer or the AI factory, that the supercomputer or the AI factory will achieve the results discussed in this release or that the supercomputer or AI factory will yield commercially successful products. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, see Lilly’s Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
“Lilly’s mission is to make life better for people around the world, and today that requires excellence not just in science but also in technology,” said Diogo Rau, executive vice president and chief information and digital officer at Lilly. “I don’t believe any other company in our industry is doing what we do at this scale. As a 150-year-old medicine company, one of our most powerful assets is decades of data. With purpose-built AI models and AI, we can set a new scientific standard that accelerates innovation to deliver medicines to more patients, faster.”
The supercomputer is the world’s first NVIDIA DGX SuperPOD with DGX B300 systems. It is powered by more than 1,000 B300 GPUs on a unified networking fabric, which means communication across GPUs, storage and related systems runs on just one high-speed network.
Transforming science at scale for real-world impact
The new supercomputer and AI factory enable rapid learning and iteration. Scientists will be able to train AI models on millions of experiments to test potential medicines, dramatically expanding the scope and sophistication of drug discovery efforts. A number of these proprietary AI models will be available on Lilly TuneLab, a collaborative federated AI/ML drug discovery platform created to expand access to advanced discovery tools across the biopharma ecosystem. TuneLab will continue evolving its suite of available models, including the addition of workflows that incorporate select NVIDIA Clara open-source models.
Beyond discovery, Lilly plans to leverage the supercomputer to shorten development cycles and help get medicines to people faster. New scientific AI agents can support researchers in reasoning, planning and collaborating across digital and physical environments. With advanced medical imaging, scientists benefit from a clearer view of how diseases progress and can develop new biomarkers for more personalized care. Manufacturing processes can benefit from digital twins together with NVIDIA’s robotic technologies to improve production efficiency and reduce downtime.
“The AI industrial revolution will have its most profound impact on medicine, transforming how we understand biology,” said Kimberly Powell, vice president of health care at NVIDIA. “Modern AI factories are becoming the new instrument of science — enabling the shift from trial-and-error discovery to a more intentional design of medicines. With its deep scientific heritage and commitment to innovation, Lilly stands as a global leader at the forefront of this new era of medical discovery.”
“Lilly is shifting from using AI as a tool to embracing it as a scientific collaborator,” said Thomas Fuchs, senior vice president and chief AI officer at Lilly. “By embedding intelligence into every layer of our workflows, we’re opening the door to a new kind of enterprise: one that learns, adapts and improves with every data point. This isn’t just about speed, but rather interrogating biology at scale, deepening our understanding of disease and translating that knowledge into meaningful advances for people served by Lilly medicines as well as the broader life sciences ecosystem.”
In accordance with Lilly’s existing sustainability commitments, including carbon neutrality by 2030, the supercomputer will run on 100% renewable electricity within existing Lilly facilities and use Lilly’s existing chilled water infrastructure for liquid cooling.
Lilly’s presentation, “Enterprise-Scale AI for Drug Discovery: Strategy, Infrastructure and Outcomes,” will take place today at NVIDIA’s AI conference GTC in Washington, D.C.
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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.