An independent data monitoring committee recommended unblinding the phase III HELIOS trial, which is evaluating Imbruvica in combination with bendamustine and rituximab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, following clinically meaningful and statistically significant treatment benefit.
The study has met its primary endpoint in extending progression-free survival. The safety profile of Imbruvica combination was consistent with prior clinical experience. Imbruvica is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc.
HELIOS, an international, placebo-controlled trial enrolled 578 CLL or SLL patients who had received at least one line of prior systemic therapy. Patients were randomized to receive either Imbruvica orally once daily in combination with six cycles of BR; or placebo orally once daily with six cycles of BR, with treatment continuing until disease progression or unacceptable toxicity.