Lilly's Jaypirca Shows Superior Response Rates In First Head-to-Head Phase 3 Trial Against Imbruvica

(RTTNews) - Eli Lilly and Company (LLY) announced results from the Phase 3 BRUIN CLL-314 clinical trial evaluating Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The study enrolled 662 patients, both treatment-naïve and relapsed/refractory, and represents the first randomized head-to-head comparison of covalent and non-covalent BTK inhibitors.

Jaypirca met its primary endpoint of non-inferiority in overall response rate (ORR) compared to Imbruvica, achieving 87.0% ORR versus 78.5% in the intent-to-treat population. Results numerically favored Jaypirca across all patient groups, including those with high-risk features such as 17p deletions, IGHV status, and complex karyotype.

Progression-free survival (PFS), a key secondary endpoint, was not yet mature at the time of analysis but trended in favor of Jaypirca. In the treatment-naïve subgroup, which had the longest follow-up, Jaypirca demonstrated a 76% reduction in the risk of disease progression or death, highlighting its potential as an earlier-line therapy.

Safety outcomes were consistent with previous trials, with Jaypirca showing a favorable profile compared to Imbruvica. Rates of atrial fibrillation/flutter (2.4% vs. 13.5%) and hypertension (10.6% vs. 15.1%) were lower with Jaypirca, and fewer patients required dose reductions or discontinued treatment due to adverse events.

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