“We look forward to the readout of BRUIN CLL-313, which assesses pirtobrutinib versus chemoimmunotherapy in treatment-naive CLL/SLL later this year.”

In context

“primary endpoint of response rate non-inferiority compared to ibrutinib and had a nominal p-value for superiority that was less than 0.05. While progression-free survival data were immature, there was a positive trend in favor of pirtobrutinib. Additional testing for progression-free survival is planned as part of a future analysis. Of note, the subpopulation of treatment-naive patients had a particularly pronounced progression-free survival trend in favor of pirtobrutinib. This subpopulation had the longest follow-up which is encouraging for what we might see more broadly across the total study population over time. This is a second positive Phase III trial to read out for pirtobrutinib as we continue to build evidence supporting the potential role for this medicine in earlier settings. We look forward to the readout of BRUIN CLL-313, which assesses pirtobrutinib versus chemoimmunotherapy in treatment-naive CLL/SLL later this year. We expect these data in combination with BRUIN CLL-314 to form the basis of regulatory submissions globally. In addition to our recent Phase III readouts, we also have updates on several other important molecules, donanemab, retatrutide and olomorasib. For donanemab, we had 3 important milestones since our last earnings call. First, we were pleased to receive a positive opinion from the CHMP in the EU. We look forward to approval and launch there later this year. Second, the modified dosing schedule was approved in the U.S., further strengthening the safety profile for donanemab, and we expect the modified dosing regimen to be part of the EU labeling at launch as well. Finally, we shared long-term extension data from TRAILBLAZER-ALZ 2, which demonstrated that, over 3 years, donanemab-trea”