Lilly's Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib)

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• In the U.S., CLL accounts for about one-quarter of the new cases of leukemia and there will be approximately 23,690 new cases of CLL diagnosed this year

  80% confidence

• These efficacy results, along with pirtobrutinib's safety profile, offer strong evidence on the role of pirtobrutinib earlier in the treatment course for patients with CLL or SLL

  80% confidence

• BRUIN CLL-314 is the first randomized study to compare covalent and non-covalent BTK inhibitors and to directly compare any BTK inhibitors in the treatment-naïve setting

  80% confidence

• Most adverse events of interest were lower with pirtobrutinib compared to ibrutinib, including atrial fibrillation/flutter (2.4% versus 13.5%) and hypertension (10.6% versus 15.1%)

  80% confidence

• Pirtobrutinib met its primary endpoint of non-inferiority on overall response rate compared to ibrutinib with 87.0% versus 78.5% (p<0.0001) in the intent-to-treat population

  80% confidence

• Jaypirca is 300 times more selective for BTK versus 98% of other kinases tested in preclinical studies

  80% confidence

• Progression-free survival showed a 76% reduction in the risk of disease progression or death in treatment-naïve patients

  80% confidence

• These data build on additional results from the BRUIN development program and recent FDA approval to reinforce the medicine's potential to deliver meaningful benefit for people living with CLL or SLL across various disease settings

  80% confidence

• BRUIN CLL-314 data are both novel and clinically significant, demonstrating an improved overall response rate and a favorable trend in progression-free survival outcomes with pirtobrutinib compared to ibrutinib

  80% confidence