Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-313 clinical trial evaluating Jaypirca (pirtobrutinib) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions. The trial compared Jaypirca, a non-covalent (reversible) BTK inhibitor, against standard chemoimmunotherapy (bendamustine plus rituximab).
The study met its primary endpoint, showing a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with Jaypirca. An independent review committee confirmed these results, highlighting one of the strongest effects ever seen with a single-agent BTK inhibitor in a frontline CLL setting.
Although overall survival (OS) data are not yet mature, early trends favor Jaypirca, with a formal analysis expected in 2026. The safety profile was consistent with previous trials of the drug across different treatment settings.
Jacob Van Naarden, Lilly’s executive vice president and president of Lilly Oncology, said the results are “striking and provocative,” reinforcing Jaypirca’s potential as a key treatment option for untreated CLL/SLL patients. He also noted the company’s plans to seek regulatory approval for earlier lines of therapy later this year, supported by data from both the BRUIN CLL-313 and BRUIN CLL-314 trials.
These findings build on earlier positive results from Phase 1/2 and other Phase 3 BRUIN studies, including BRUIN CLL-321 and the head-to-head BRUIN CLL-314 trial against ibrutinib. Together, these studies position Jaypirca as a promising therapy for various CLL/SLL patient groups, including those new to BTK inhibitors and those previously treated with them.
Detailed trial data will be presented at upcoming medical conferences and submitted for peer-reviewed publication.