Imbruvica Meets Primary Endpoint in CLL/SLL Study

Pharmacyclics Inc. announced today that the company would be ending its phase III trial of Imbruvica because the primary and one key secondary endpoint of the study have been met.

The company informed the FDA that an Independent Data Monitoring Committee (IDMC) had unanimously recommended that they halt the phase III RESONATE study, since an interim analysis showed a statistically significant improvement in progression-free survival (the primary endpoint) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Analysis also showed statistically significant improvement in overall survival (one of the secondary endpoints) among these patients.

"We are very pleased with the vigilance and professional expertise that our IDMC exercised in monitoring this study," said Fong Clow, Sc. D, Senior Vice President of Biometrics at Pharmacyclics. "The results seen at the interim analysis of the RESONATE trial are robust and consistent."

About the study

The RESONATE study is a randomized, multicenter, open-label Phase III study of single agent Imbruvica against single agent ofatumumab in patients with relapsed or refractory CLL or relapsed or refractory SLL with measurable nodal disease and who were not eligible for treatment with purine analog-based therapy. The study enrolled 391 patients who had received at least one prior therapy. Patients were randomized to receive 420 mg of Imbruvica orally once daily or intravenous doses of ofatumumab over the course of 24 weeks until disease progression or unacceptable toxicity.

Imbruvica was previously approved by the U.S. FDA for the treatment of some patients with mantle cell lymphoma.

Source: Pharmacyclics