Eli Lilly announced positive results from its Phase 3 BRUIN CLL-322 trial for Jaypirca (pirtobrutinib). Adding Jaypirca to a standard treatment of venetoclax and rituximab reduced the risk of disease progression or death by 45%. The study focused on patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The trial enrolled 639 patients. Most participants had previously received treatment with a BTK inhibitor. At a median follow-up of 27.3 months, the Jaypirca combination arm had not yet reached median progression-free survival. The control group reached median progression-free survival at 39.7 months.
The combination safety profile matched the known profiles of the individual drugs. Eli Lilly plans to submit these data to global regulatory authorities for potential label expansion. The company will present the findings at the 2026 European Hematology Association (EHA) Annual Meeting. These results may establish a new standard of care for relapsed or refractory CLL/SLL.