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Lilly's Jaypirca (Pirtobrutinib) Met Its Primary Endpoint in First-of-Its-Kind, Head-to-Head Phase 3 Study versus Imbruvica (Ibrutinib)

Pirtobrutinib matched ibrutinib’s overall response rate with a 76% lower risk of progression or death in frontline patients and fewer cardiovascular side effects, researchers said.

  • The Phase 3 BRUIN CLL-314 study announced that pirtobrutinib was statistically non-inferior to ibrutinib for IRC-assessed ORR, with results presented at ASH and published in the Journal of Clinical Oncology.
  • Non-Covalent BTK inhibitors were developed to overcome resistance to covalent BTK inhibitors, and the BRUIN CLL-314 trial uniquely enrolled treatment-naive patients alongside relapsed/refractory patients.
  • Interim PFS data show a trend favoring pirtobrutinib, including a 76% reduction in progression or death risk in the treatment-naive subgroup , with a planned formal analysis.
  • Although overall treatment-emergent adverse event rates and AE-related discontinuations were similar, patients on pirtobrutinib had fewer AE-related dose reductions and lower atrial fibrillation/flutter and hypertension rates.
  • Lilly will present BRUIN CLL-313 results on Dec. 9, and a formal PFS superiority analysis is planned; Dr. Jennifer Woyach said pirtobrutinib may be preferred over covalent BTK inhibitors in some patients.
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Lilly's Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib)

In addition to meeting the primary endpoint of non-inferiority for overall response rate (ORR) in the BRUIN CLL-314 study, pirtobrutinib achieved a numerically higher ORR of 87.0% compared to 78.5% for ibrutinib in the intent-to-treat (ITT) population

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biopharmadive.com broke the news in on Sunday, December 7, 2025.
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