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Positive results from the Phase 3 BRUIN CLL-322 study comparing time-limited pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory CLL/SLL will be highlighted in a late-breaking oral presentation
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Ajax Therapeutics, which Lilly has agreed to acquire, will present the first clinical data for its first-in-class type II JAK2 inhibitor for patients with myelofibrosis who have been failed by a type I JAK2 inhibitor
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Kelonia Therapeutics, which Lilly has agreed to acquire, will present additional correlative clinical data for its in vivo CAR-T program in patients with multiple myeloma
INDIANAPOLIS, June 2, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the details of presentations at theEuropean Hematology Association(EHA) Annual Meeting, taking placeJune 11-14inStockholm, Sweden.
Data to be highlighted include an oral presentation detailing results from the Phase 3 BRUIN CLL-322 study of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, as part of a time-limited regimen for patients with previously treated chronic lymphocytic leukemia (CLL). Lilly is strengthening its hematology portfolio through the recently announced proposed acquisitions ofAjax Therapeutics, Inc.* andKelonia Therapeutics, Inc.*, each of which will present data at the meeting. Ajax Therapeutics will present the first clinical data from the Phase 1 AJX-101 study evaluating AJ1-11095, an investigational first-in-class type II JAK2 inhibitor, in patients with myelofibrosis who have been failed by a type I JAK2 inhibitor. Kelonia Therapeutics will present additional correlative data from the Phase 1 inMMyCAR study of an investigational anti-B-cell maturation antigen (BCMA) targeted in vivo CAR-T therapy in patients with relapsed and refractory multiple myeloma. Both proposed acquisitions by Lilly are pending transaction closes.
"These data at EHA represent a significant moment for Lilly's hematology ambitions," saidJacob Van Naarden, executive vice president and president of Lilly Oncology. "The Phase 3 BRUIN CLL-322 results address an important question for patients with relapsed or refractory CLL, demonstrating that time-limited pirtobrutinib can meaningfully improve outcomes when added to an already effective venetoclax-based regimen. Alongside the first clinical data from Ajax and additional results from Kelonia in support of the recently presented data at ASCO, these results reflect our relentless commitment to pursue meaningful advancements for people living with blood disorders."
Presentation Highlights:
Lilly:
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In a late-breaking oral presentation, Lilly will share results from the Phase 3 BRUIN CLL-322 study, evaluating a time-limited regimen of pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory CLL/SLL. BRUIN CLL-322 is the first Phase 3 readout in CLL to outperform a venetoclax-containing control arm in any CLL setting. Lilly previously announced that 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). These results were also selected to be featured in the EHA press program.
Ajax Therapeutics:
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In an oral presentation, Ajax will share the first clinical results from the Phase 1 AJX-101 clinical trial, evaluating AJ1-11095, an investigational first-in-class type II JAK2 inhibitor, in patients with myelofibrosis who have been failed by a type I JAK2 inhibitor. These data will also be featured in the EHA press program.
Kelonia Therapeutics:
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In an oral presentation, Kelonia will share additional correlative data from the Phase 1 inMMyCAR dose-escalation study, evaluating KLN-1010 in relapsed or refractory multiple myeloma. Data from this study were recently shared at the
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American Society of Clinical Oncology
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(ASCO) Annual Meeting.
A full list of abstract titles and viewing details are listed below:
*Lilly and Ajax Therapeutics, Inc., andLilly and Kelonia Therapeutics, Inc., remain separate, independent companies prior to closing. Both transactions are subject to customary closing conditions, including regulatory approvals, with Ajax Therapeutics expected to close inJune 2026and Kelonia Therapeutics expected to close in the second half of 2026.
About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib) (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 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 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