Eli Lilly and Company (NYSE:LLY) said its therapy Jaypirca achieved the primary endpoint in a Phase 3 trial involving patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The BRUIN CLL-322 study evaluated Jaypirca in combination with venetoclax and rituximab against a regimen of venetoclax and rituximab alone in 639 patients with relapsed or refractory disease. The addition of Jaypirca led to a statistically significant improvement in progression-free survival, based on assessment by an independent review committee.
Patients in both arms received treatment for up to two years before stopping therapy until disease progression. The benefit of the Jaypirca-based combination was observed consistently across patient subgroups, including those who had previously been treated with covalent BTK inhibitors.
While overall survival data is not yet mature, early trends favored the Jaypirca combination. The treatment demonstrated a safety profile aligned with the known characteristics of each drug, with comparable adverse event rates between groups and low discontinuation levels.
The company said it intends to submit the findings to regulators later this year in support of expanding the drug’s approved uses. Full data from the study will be presented at a forthcoming medical conference and published in a peer-reviewed journal.
This represents the fourth successful Phase 3 trial of Jaypirca in CLL, adding to earlier results from the BRUIN program, including studies in treatment-naïve patients and those previously treated with BTK inhibitors.
Jaypirca is currently approved for adults with relapsed or refractory CLL or SLL who have received prior treatment with a covalent BTK inhibitor, as well as for certain patients with mantle cell lymphoma.