Lilly's Jaypirca (pirtobrutinib) significantly improved progression-free survival, reducing the risk of progression or death by 80%, versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL
View original at finance.yahoo.comLilly's Jaypirca (pirtobrutinib) significantly improved progression-free survival, reducing the risk of progression or death by 80%, versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL The risk reduction observed in BRUIN CLL-313 is among the most compelling observed for a single agent BTK inhibitor in a…
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In the U.S., CLL accounts for about one-quarter of new cases of leukemia and there will be approximately 23,690 new cases of CLL diagnosed this year
80% confidenceLilly hopes to receive regulatory approvals for pirtobrutinib in earlier disease settings sometime next year, further expanding treatment options for patients
80% confidenceJaypirca is 300 times more selective for BTK versus 98% of other kinases tested in preclinical studies
80% confidenceJaypirca met its primary endpoint demonstrating a reduction in the risk of disease progression or death by 80% (HR=0.20 [95% CI, 0.11-0.37]; p<0.0001) versus bendamustine plus rituximab in treatment-naïve CLL/SLL patients
80% confidenceThe risk reduction observed in BRUIN CLL-313 is among the most pronounced ever observed for a single agent BTK inhibitor in a front-line CLL study
80% confidenceAt median follow-up of 28.1 months, PFS results favored pirtobrutinib across all pre-specified subgroups, including those with high-risk molecular features such as TP53 mutations, complex karyotype, and unmutated IGHV
80% confidenceJaypirca is the only BTK inhibitor to show promise in treating both newly diagnosed patients with CLL or SLL and those who have progressed on a covalent BTK inhibitor
80% confidenceThe magnitude of the progression-free survival benefit, early overall survival trend and safety profile observed in BRUIN CLL-313 offer highly compelling evidence for the potential role of pirtobrutinib in treatment-naïve CLL
80% confidenceOverall survival remains immature but a trend favoring pirtobrutinib was observed (HR=0.257 [95% CI, 0.070–0.934]; p=0.0261) despite over half (52.9%) of patients treated with BR crossing over to receive pirtobrutinib after disease progression
80% confidenceGrade ≥3 treatment-emergent adverse events occurred in 40.0% of patients who received pirtobrutinib versus 67.4% with BR, with fewer dose reductions and discontinuations
80% confidence