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Eli Lilly (NYSE:LLY) announced on Tuesday that its FDA-approved Bruton’s tyrosine kinase inhibitor, Jaypirca, met the primary goal in a late-stage trial versus J&J (NYSE:JNJ) and AbbVie’s (NYSE:ABBV) Imbruvica, which belongs to a similar drug class.
The Phase 3 BRUIN CLL-314 is a head-to-head trial comparing Jaypirca (pirtobrutinib) with Imbruvica (ibrutinib) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had been newly diagnosed or had not previously received BTK inhibitors.
Citing its topline data, LLY said BRUIN CLL-314 met its primary endpoint related to non-inferiority on overall response rate for both pre-treated and intent-to-treat patients, as pirtobrutinib indicated a favorable ORR with statistical superiority.
While data for the secondary endpoint related to progression-free survival were not mature, there was a trend favoring pirtobrutinib, the Indiana-based drugmaker noted, adding that a future analysis is expected to measure the PFS superiority.
As for tolerability, Jaypirca indicated a safety profile in line with findings from its prior studies, the company said, adding that it plans to disclose detailed results at a medical event later this year.
Both Jaypirca and Imbruvica are FDA-approved oral medications indicated in the U.S. for conditions including CLL and SLL.