Eli Lilly and Company (NYSE: LLY) announced that its drug Jaypirca met the primary endpoint in a Phase 3 trial for patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

The BRUIN CLL-322 trial tested Jaypirca combined with venetoclax and rituximab against venetoclax and rituximab alone in 639 patients with relapsed or refractory disease. The study demonstrated a statistically significant improvement in progression-free survival when Jaypirca was added to the standard combination, as assessed by an independent review committee.

Treatment was administered for up to two years in both study arms, after which patients stopped taking therapy until disease progression. Results were consistent across patient subgroups, including those previously treated with covalent BTK inhibitors.

Overall survival data was not yet mature at this analysis but showed a trend favoring the Jaypirca combination. The safety profile was consistent with known profiles of each medicine, with similar adverse event rates across study arms and low treatment discontinuation rates.

The company plans to submit these results to regulators later this year for a label expansion. Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal.

This marks the fourth positive Phase 3 study of Jaypirca in chronic lymphocytic leukemia, building on previously reported results from other BRUIN trials including studies in treatment-naive patients and those previously treated with BTK inhibitors.

Jaypirca is currently approved for treating adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have been previously treated with a covalent BTK inhibitor, and for certain mantle cell lymphoma patients.