Eli Lilly and Company (NYSE: LLY) announced that its Phase 3 BRUIN CLL-322 clinical trial met its primary endpoint, showing that Jaypirca (pirtobrutinib) combined with venetoclax and rituximab reduced the risk of disease progression or death by 45% compared to venetoclax and rituximab alone in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).

The study enrolled 639 patients, with 79.8% having prior covalent BTK inhibitor exposure. Participants were randomized to receive either pirtobrutinib plus venetoclax and rituximab (321 patients) or venetoclax and rituximab alone (318 patients). At a median follow-up of 27.3 months, the combination therapy demonstrated a hazard ratio of 0.55 with a 95% confidence interval of 0.40-0.75 and p-value of 0.0001.

The median progression-free survival was not reached in the combination arm compared to 39.7 months in the control arm. Results were consistent across patient subgroups, including those with prior covalent BTK inhibitor exposure and high-risk disease features.

"These results from BRUIN CLL-322 show that the addition of pirtobrutinib as part of a time-limited regimen further enhanced an already effective treatment and extended the duration of remission for patients with previously treated CLL," said Matthew S. Davids, Chief of the Division of Lymphoma at Dana-Farber Cancer Institute and the study's lead author.

The safety profile showed similar rates of Grade 3 or higher adverse events between the combination and control arms at 78.8% and 73.0% respectively. Discontinuation rates due to treatment-related adverse events were comparable at 5.4% versus 5.1%.

Lilly plans to submit these results to global regulatory authorities to expand Jaypirca's approved indications. The data will be presented at the 2026 European Hematology Association Annual Meeting in Stockholm.