Eli Lilly's Jaypirca Surpasses Chemoimmunotherapy For Untreated Blood Cancer Patients
Eli Lilly and Co (NYSE:LLY) on Monday shared topline results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus chemoimmunotherapy (bendamustine plus rituximab), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.
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The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemoimmunotherapy.
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Overall survival (OS), a key secondary endpoint, was not yet mature at this analysis, but was trending strongly in favor of pirtobrutinib and will be tested for statistical significance at the time of the primary OS analysis, which is anticipated to occur in 2026.
The overall safety profile of pirtobrutinib in BRUIN CLL-313 was generally consistent with previously reported trials across treatment settings.
Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal.
The results from the BRUIN CLL-313 and BRUIN CLL-314 studies will form the basis for seeking label expansions in earlier lines of therapy, with global regulatory submissions beginning later this year.
These data build on the previously reported positive results from the BRUIN Phase 1/2 trial, the Phase 3 BRUIN CLL-321 trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population, and the Phase 3 BRUIN CLL-314 trial, the first-ever head-to-head Phase 3 trial versus ibrutinib in CLL to include treatment-naïve patients.
In August, Eli Lilly released topline results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial.
Treatment with two years of Verzenio plus endocrine therapy (ET) demonstrated a statistically significant and clinically meaningful improvement in OS compared to ET alone in patients with hormone receptor positive (HR+), HER2-, node-positive, high-risk early breast cancer.
LLY Price Action: Eli Lilly stock is up 0.56% at $731.30 at publication on Monday.
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