Eli Lilly, a leading US pharmaceutical company, has recently reported positive top-line results from the Phase III BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. The study compared Jaypirca with Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The trial included patients with treatment-naïve CLL/SLL as well as those who had been previously treated but had not received a BTK inhibitor before.
The study successfully met its primary endpoint of non-inferiority in overall response rate (ORR) as evaluated by an independent review committee (IRC) in both pre-treated and intent-to-treat populations. Notably, the ORR favored pirtobrutinib with a nominal P-value indicating superiority (p <0.05). While the progression-free survival (PFS) endpoint was not yet mature at the time of analysis, it was showing positive trends in favor of pirtobrutinib. Further analysis for PFS superiority is planned for the future. Importantly, no negative impact on overall survival (OS) was observed. These promising results demonstrate the potential of Jaypirca in the treatment of CLL/SLL and highlight its efficacy as a BTK inhibitor.
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