Eli Lilly and Co. (NYSE:LLY) said Sunday that its Phase 3 BRUIN CLL-322 trial met its primary endpoint, with the addition of Jaypirca (pirtobrutinib) to venetoclax and rituximab significantly improving progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
The study found that adding Jaypirca to a time-limited two-year regimen of venetoclax and rituximab reduced the risk of disease progression or death by 45% compared with venetoclax and rituximab alone.
Phase 3 Trial Delivers Strong Progression-Free Survival Benefit
The BRUIN CLL-322 study enrolled 639 patients with relapsed or refractory CLL/SLL, nearly 80% of whom had previously received a covalent BTK inhibitor. Participants were randomly assigned to receive either pirtobrutinib plus venetoclax and rituximab (PVR) or venetoclax and rituximab (VR).
Based on a February 2, 2026, data cutoff and a median follow-up of 27.3 months, the PVR regimen significantly improved independent review committee-assessed progression-free survival versus VR alone.
Median progression-free survival was not reached in the PVR arm, compared with 39.7 months in the VR arm.
The benefit was observed across prespecified patient groups, including those previously treated with covalent BTK inhibitors and patients with high-risk disease characteristics such as TP53 mutations, 17p deletion, unmutated IGHV, or complex karyotype.
Additional Endpoints Favor Jaypirca Combination
While overall survival data remain immature, Lilly reported that another secondary endpoint, time to next treatment, favored the pirtobrutinib combination regimen, with a hazard ratio of 0.50.
The company said results from BRUIN CLL-322 will be presented in a late-breaking oral session at the 2026 European Hematology Association Annual Meeting and featured in the conference press program.
Lilly plans to submit the study results to global regulatory authorities as it seeks to expand Jaypirca’s approved label. The company is also evaluating the therapy in several additional Phase 3 studies in CLL/SLL.
LLY Price Action: Eli Lilly shares were down 0.19% at $1130.86 at the time of publication on Monday. The stock is approaching its 52-week high of $1182.73, according to Benzinga Pro data.
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