Eli Lilly to present data from 2 Jaypirca studies at ASH Annual Meeting

Eli Lilly (LLY) announced that data from studies of Jaypirca, the first and only approved non-covalent Bruton tyrosine kinase inhibitor, will be presented at the 67th American Society of Hematology Annual Meeting and Exposition, taking place Dec. 6-9 in Orlando, Florida. Key data presentations for Jaypirca include: In an oral presentation, Lilly will share results from the BRUIN CLL-314 study, comparing pirtobrutinib to Imbruvica, a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Lilly previously announced that pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority less than 0.05. BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naive patients. These results were also selected to be highlighted in the ASH Annual Meeting press program session on Dec. 7. In a late-breaking oral presentation, Lilly will share results from the Phase 3 BRUIN CLL-313 study of pirtobrutinib versus chemoimmunotherapy in patients with treatment-naive CLL/SLL without del(17p). Lilly previously announced the study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival with pirtobrutinib compared to chemoimmunotherapy. These results were also selected to be highlighted in the ASH Annual Meeting press program session on Dec. 8. In other oral and poster presentations, Lilly will share additional data from the Phase 1/2 BRUIN study in patients with relapsed or refractory CLL, mantle cell lymphoma and Waldenstrom macroglobulinemia. These long-term data include efficacy and safety results with approximately five years of follow-up. In an oral presentation, results will be shared from an investigator-initiated Phase 2 study of time-limited treatment with a combination of pirtobrutinib, venetoclax, and obinutuzumab in treatment-naive CLL. “Building on our previous announcements of positive topline results for the Phase 3 BRUIN CLL-313 and CLL-314 studies, we are excited to share the full results at ASH,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “Collectively, data from across the pirtobrutinib development program and investigator-led studies reinforce the medicine’s unique clinical profile and its potential role across treatment settings and B-cell malignancies.”