Eli Lilly Touts 'Striking' Progression-Free Survival Results for Jaypirca in New Front-Line CLL Study

on

Lilly announced positive topline results from the Phase 3 BRUIN CLL-313 trial, showing Jaypirca (pirtobrutinib) achieved a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) for treatment-naïve CLL and SLL patients compared to standard chemoimmunotherapy (bendamustine plus rituximab)1234.

The magnitude of PFS benefit is described as 'one of the most compelling effect sizes ever observed' for a single agent BTK inhibitor in a front-line CLL study, suggesting Jaypirca’s strong efficacy as initial therapy2345.

Jaypirca's overall safety profile in the study was consistent with previously reported trials for the drug34.

Although the overall survival (OS) data are not mature, Lilly reported that OS is trending in favor of Jaypirca and will be subject to statistical testing in the planned primary analysis in 2026134.

Lilly is seeking to expand Jaypirca's label for use in the first-line setting for CLL/SLL based on these results, with detailed findings to be presented at a future medical congress and submitted for publication3.

Sources:

1. https://www.oncologypipeline.com/apexonco/jaypirca-gets-front-line-win

2. https://www.ainvest.com/news/eli-lilly-jaypirca-shows-promising-results-cll-phase-3-trial-shares-rise-16-2509/

3. https://www.clinicaltrialsarena.com/news/lilly-to-seek-jaypirca-label-expansion-for-first-line-cll-sll-usage/

4. https://www.ainvest.com/news/eli-lilly-reports-positive-phase-3-results-jaypirca-cll-sll-treatment-2509/

5. https://www.fiercepharma.com/pharma/compelling-results-eli-lillys-jaypirca-advances-one-step-closer-first-line-use