In frontline newly diagnosed elderly CLL/SLL patients, Pharmacyclics most recently initiated a Phase III trial RESONATE™ -2 (PCYC-1115/1116). This trial is a randomized, multicenter, open-label study of ibrutinib (PCI-32765) as a monotherapy versus chlorambucil in patients 65 years or older with treatment naïve CLL/SLL. The study design is in accord with a Special Protocol Assessment (SPA). The study is designed to demonstrate superiority of ibrutinib with the primary endpoint of progression-free survival (PFS); the comparator is single agent chlorambucil. This global study is planned to enroll 272 patients worldwide.In relapsed/refractory CLL/SLL patients Pharmacylics initiated RESONATE TM (PCYC-1112), which is a randomized, open–label, pivotal Phase III trial. The trial is designed to demonstrate superiority of ibrutinib versus ofatumumab. The primary endpoint of the study is to demonstrate a clinically significant improvement in progression-free survival in relapsed or refractory CLL/SLL patients. This global study is open and Pharmacyclics plans to enroll 350 patients worldwide.
Pharmacyclics® Announces Updated Results For BTK Inhibitor Ibrutinib (PCI-32765) At American Society Of Hematology (ASH) Annual Meeting
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