Janssen R&D announced results of a pre-planned interim analysis of the Phase 3 HELIOS (CLL3001) trial studying the combination of Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) plus bendamustine and rituximab (BR) vs. placebo plus BR in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

HELIOS is a randomized, double-blind, placebo-controlled, international, multicenter study, which evaluated the safety and efficacy of Imbruvica in combination with BR in 578 patients with relapsed or refractory CLL/SLL who had received at least one prior therapy. Patients were randomized to receive either the combination of Imbruvica and six cycles of BR, or a matching regimen of placebo and six cycles of BR, with Imbruvica or placebo continued until disease progression or unacceptable toxicity. The primary endpoint of the HELIOS study is progression-free survival (PFS).

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The primary endpoint of PFS was met in this study, demonstrating a statistically significant improvement. An Independent Data Monitoring Committee (IDMC) recommends that the study be unblinded and those patients that are receiving placebo plus BR be offered the option to receive Imbruvica as their next treatment.

Imbruvica is already indicated for mantle cell lymphoma (MCL) in patients who have received at least one prior therapy and in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. It is also indicated for CLL in patients with 17p deletion.

For more information call (877) 877-3536 or visit Imbruvica.com.