Lilly’s Jaypirca significantly improved progression-free survival in patients with treatment-naïve CLL/SLL

Eli Lilly has recently announced their new positive topline results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca, a non-covalent Bruton tyrosine kinase inhibitor, versus chemoimmunotherapy, in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma without 17p deletions. Note that the study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival compared to chemoimmunotherapy, as assessed by an independent review committee, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study.

Note that detailed results are to be presented at a medical congress and submitted to a peer-reviewed journal. The results from the BRUIN CLL-313 and BRUIN CLL-314 studies will form the basis for seeking label expansions in earlier lines of therapy, with global regulatory submissions beginning later this year.

“The results from BRUIN CLL-313 are striking and provocative, across both PFS and OS endpoints, further demonstrating the potential of pirtobrutinib to be a meaningful treatment option for people with untreated CLL/SLL,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “With this third positive Phase 3 study, we continue to build the clinical evidence supporting the possible role of pirtobrutinib in a variety of CLL/SLL treatment settings, including treatment-naïve, BTK inhibitor-naïve and BTK inhibitor exposed. We look forward to presenting these data, as well as data from the recently announced positive BRUIN CLL-314 study, at upcoming medical meetings and preparing global regulatory submissions, with the goal of making pirtobrutinib an option for a wider group of patients who might benefit.”

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Related Topics and Keywords

jaypirca, Lilly's Jaypirca (pirtobrutinib), naïve CLL/SLL