publication date: Mar. 31, 2015
Phase III Trial of Imbruvica Unblinded Following Significant Increase in PFS
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.
These top-line results will be submitted for presentation at the upcoming American Society of Clinical Oncology Annual Meeting and the full results will be submitted for publication in a peer-reviewed journal, according to the drug’s sponsor. A full study report is being prepared and will be submitted to health authorities for future labeling considerations.
Imbruvica is being studied alone and in combination with other treatments in several blood cancers. Over 5,100 patients have been treated in clinical trials of Imbruvica conducted in 35 countries by more than 800 investigators. Currently, 13 phase III trials have been initiated with Imbruvica and 58 trials are registered on www.clinicaltrials.gov.
Imbruvica is a first-in-class, oral, once-daily therapy that inhibits Bruton’s tyrosine kinase. BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role … Continue reading CCL March – Phase III Trial of Imbruvica Unblinded Following Significant Increase in PFS
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