Ibrutinib Trials Against SLL/CLL and MCL Complete Enrollment

Pharmacyclics is announcing that they have met their enrollment target of 350 patients for a Phase III study of ibrutinib monotherapy compared to ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL).

The so-called RESONATE trial is now officially closed to enrollment.

The primary endpoint will be to demonstrate a clinically significant improvement in progression-free survival (PFS) with ibrutinib compared to ofatumumab.

Depending on the interim analysis of data, the company may seek an early filing for the drug with the US Food and Drug Administration.

Said Maria Fardis, Chief of Oncology Operations and Alliances at Pharmacyclics:

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.

Additionally, Pharmacyclics has completed enrollment for a Phase II single-arm study using ibrutinib in patients with mantle cell lymphoma (MCL) whose disease has progressed following bortezomib therapy and have received at least one prior rituximab-containing chemotherapy regimen

The so-called SPARK global study will have as its primary endpoint overall response rate (ORR).

The company intends to file a New Drug Application (NDA) with the FDA for the use of ibrutinib in patients with relapsed or refractory MCL prior to year-end.

Ibrutinib is a drug that was designed specifically to target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK), a key mediator of as many as three critical B-cell pro-survival mechanisms: regulation of apoptosis, cell adhesion, and cell migration and homing.

Source: Pharmacyclics