Lilly’s Jaypirca meets primary endpoint in Imbruvica comparison
Eli Lilly (NYSE: LLY) has announced positive top-line results from the Phase III BRUIN CLL-314 trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
The study enrolled patients with treatment-naïve CLL/SLL and those who had been previously treated but were BTK inhibitor-naïve, and met its primary endpoint of non-inferiority on overall response rate (ORR) as assessed by an independent review committee (IRC) in both the pre-treated and intent-to-treat populations. ORR favored Jaypirca with a nominal P-value for superiority.
These data mark the second positive Phase III study in the program
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