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.
Pharmacylics has also initiated the RESONATE TM-17p study (PCYC-1117), which is a randomized, open–label Phase II trial using ibrutinib as a monotherapy in patients who have deletion 17p and who did not respond to or relapsed after at least one prior treatment with chemoimmunotherapy (a high unmet need population). The primary outcome of the study will be overall response rate. The key secondary endpoints will be duration of response and other measures of clinical benefit. This study is planned to enroll 111 patients worldwide.
Pharmacyclics' worldwide partner Janssen most recently initiated a randomized, multi-center, double blinded, placebo controlled, pivotal Phase III trial of ibrutinib in combination with bendamustine and rituximab in relapsed/refractory CLL/SLL patients who received at least one line of prior systemic therapy. The primary endpoint of the study is to demonstrate a clinically significant improvement in progression-free survival versus bendamustine and rituximab therapy alone. The key secondary endpoints include overall response rate, overall survival and other measures of clinical benefit. This global study is open and Janssen plans to enroll 580 patients worldwide.