Johnson & Johnson, Pharmacyclics' Imbruvica meets main goal of head-to-head study versus Arzerra

Johnson & Johnson's partner Pharmacyclics announced Tuesday that a Phase III trial in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) is being stopped early after meeting its main goal, with Imbruvica (ibrutinib) showing a significant improvement in progression-free survival versus GlaxoSmithKline and Genmab's Arzerra (ofatumumab). The company noted that Imbruvica also demonstrated a significant improvement in overall survival, a key secondary endpoint of the RESONATE study.

Based on the findings from the planned interim analysis, the trial's independent Data Monitoring Committee (DMC) recommended that patients in the Arzerra arm be provided access to Imbruvica. Pharmacyclics indicated that it has informed the FDA of the DMC's recommendation to halt the study, while Johnson & Johnson has informed the European Medicines Agency. In July 2013, the companies filed for FDA approval of the Bruton's tyrosine kinase inhibitor in certain patients with CLL and SLL based on results from two Phase II studies. Pharmacyclics said Tuesday that the drugmakers "are engaging in a dialogue with the health authorities to define the next regulatory steps."

The RESONATE trial enrolled 391 patients with relapsed or refractory CLL or relapsed or refractory SLL with measurable nodal disease who were not suitable for treatment with purine analogue-based therapy. Each patient had received at least one previous therapy. In the study, patients were randomised to receive Imbruvica orally once daily or Arzerra intravenously for 24 weeks or until disease progression or unacceptable toxicity. Pharmacyclics indicated that the safety profile of Imbruvica was consistent with previous clinical studies. The company added that data from the study will be presented at a future conference.

In November 2013, the FDA approved Imbruvica for patients with mantle cell lymphoma who have received at least one prior therapy.

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