AbbVie submits Imbruvica phase III combination data to FDA

The Phase III trial assessed Imbruvica plus bendamustine and rituximab (BR) versus placebo plus BR in relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The results confirmed the therapy’s ability to improve the effectiveness of a commonly used treatment option in the patients.

Imbruvica is jointly developed and commercialized by AbbVie subsidiary Pharmacyclics, and Janssen Biotech.

About 578 CLL or SLL patients were enrolled in HELIOS trial, which was sponsored by Janssen. Subjects had received at least one prior systemic therapy.

Patients were randomized to receive Imbruvica or placebo, once daily continuing until disease progression or unacceptable toxicity with six cycles of BR, or placebo plus BR.

Pharmacyclics president Erik von Borcke said: "Imbruvica has demonstrated that it is an effective treatment option as a single-agent in patients with relapsed or refractory chronic lymphocytic leukemia and the results of HELIOS confirm the therapy’s ability to also provide a significant benefit to these patients when added to the commonly used and effective bendamustine and rituximab treatment combination."

Imbruvica is cleared in the US to treat patients with CLL who have received at least one prior treatment, chronic CLL with 17p deletion, Waldenstrom’s macroglobulinemia and mantle cell lymphoma patients who have received at least one prior treatment.

It is being studied alone and in combination with other treatments in various blood cancers.

More than 6,100 patients have been treated in clinical trials of Imbruvica undertaken in 35 countries. Currently, 16 Phase III trials have been started with Imbruvica.