Pharmacyclics, Inc, announced today that the enrollment target of 350 patients for RESONATE, its phase III study using ibrutinib monotherapy vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, was achieved on April 3, 2013. As of today, an additional 41 patients were screened and are allowed to participate in this study, which is now officially closed to enrollment.
The primary endpoint of this phase III study is to demonstrate a clinically significant improvement in progression-free survival with ibrutinib when compared to ofatumumab. A predefined number of progression events will trigger an interim analysis. If the treatment effect of ibrutinib in comparison to ofatumumab is deemed statistically favorable by an independent review committee, a discussion with the FDA and other health authorities for a potential early filing can take place.
"In addition to our outstanding team, we are grateful to the patients, their treating physicians, and the clinical sites for their participation in our RESONATE study and their strong support of the ibrutinib program," said Maria Fardis, PhD, MBA, Chief of Oncology Operations and Alliances at Pharmacyclics.
Pharmacyclics also announced the completion of enrollment of the planned 110 patients in the phase II single-arm SPARK (MCL2001) study using ibrutinib in patients with mantle cell lymphoma (MCL) who have disease progression after bortezomib (Velcade) therapy and have received at least one prior rituximab (Rituxan)-containing chemotherapy regimen. This global study is conducted by Janssen Research & Development, LLC, and its primary endpoint is overall response rate, which is scheduled to be evaluated 6 months from the completion of enrollment. Further updates to this study will be provided by Janssen.
New Drug Application Planned for Ibrutinib
Pharmacyclics expects to file a New Drug Application with the FDA for the use of ibrutinib in patients with relapsed or refractory MCL before the end of the year. In the time before a potential U.S. marketing approval, the company aims to provide early access to ibrutinib under an Early Access Program (EAP). A multicenter, open-label EAP, conducted by Janssen, will be initiated in the United States with ibrutinib for relapsed or refractory MCL patients.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.