Eli Lilly (LLY) announced on Tuesday that its Bruton tyrosine kinase inhibitor Jaypirca (pirtobrutinib) reached the main goal in a Phase 3 trial for certain newly diagnosed patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Citing a July 11 data cutoff, the Indiana-based drugmaker said that Jaypirca, currently available in the U.S. as a late-line option for relapsed or refractory CLL/SLL, reached the primary endpoint in its Phase 3 BRUIN CLL-313 clinical trial.
The 282-subject trial involving previously untreated CLL/SLL patients without a specific genetic characteristic called 17p deletions was designed to evaluate orally delivered Jaypirca versus the cancer combination regimen of bendamustine and rituximab (BR).
Based on a median follow-up of 28.1 months, the company said BRUIN CLL-313 was a success, as pirtobrutinib reduced the risk of disease progression or death by 80% with a safety profile consistent with prior studies.
Lilly (LLY) plans to conduct another analysis at a future date to evaluate overall survival, a secondary endpoint of BRUIN CLL-313, for which data showed a favorable trend but was immature for a comprehensive readout.
The company is studying Jaypirca across multiple clinical studies in CLL/SLL, and it has started submitting data from the BRUIN CLL-313 and BRUIN CLL-314 studies to regulatory authorities to expand the drug’s label into earlier lines of therapy.