Johnson & Johnson, Pharmacyclics' Imbruvica achieves main goal in Phase III study of CLL, SLL

Johnson & Johnson and Pharmacyclics announced Monday that an interim analysis of a Phase III study investigating Imbruvica (ibrutinib), in combination with Teva's Treanda (bendamustine) and Roche's Rituxan (rituximab) versus placebo in combination with Treanda and Rituxan, showed the trial met its primary endpoint of prolonged progression-free survival ​in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)​.​ Based on the study results, an independent data monitoring committee recommended that the trial be unblinded with all patients in the placebo arm being offered Imbruvica. "This is the second randomised, controlled study in patients with previously treated CLL or SLL to show a significant improvement in progression-free survival, further underscoring the potential of Imbruvica," remarked Sen Zhuang, vice president of oncology clinical research at Johnson & Johnson's Janssen Research & Development unit.

The HELIOS study randomised 578 patients with CLL or SLL, who had received at least one prior therapy, to be administered treatment with Imbruvica or placebo, both in combination with Treanda and Rituxan, with treatment continuing until disease progression or unacceptable toxicity. In addition to the primary endpoint, the secondary endpoints of the study included safety endpoints, overall response rate, overall survival, the rate of minimal residual disease-negative responses and other improvements in hematologic values, disease-related symptoms and patient-reported outcome scores.

"These results build upon early results in the Phase I/II programme and are very encouraging as we continue to explore the benefits IMBRUVICA provides to patients when it is combined with other treatments," commented Pharmacyclics' head of oncology Danelle James. The drugmakers said that results from the study will be submitted for presentation at the American Society of Clinical Oncology annual meeting, as well as submitted for publication in a peer-reviewed medical journal.

Under the terms of a 2011 collaboration, Johnson & Johnson and Pharmacyclics share development and commercialisation activities for the blood cancer treatment. Imbruvica was most recently cleared by the FDA for the treatment of Waldenstrom's macroglobulinaemia in January. The therapy was previously approved by the regulator for the treatment of mantle cell lymphoma, CLL as well as CLL in patients who carry the 17p deletion.

Meanwhile, Pharmacyclics reached an agreement to be acquired by AbbVie earlier this month for about $21 billion. A prior report suggested that Johnson & Johnson was considering an offer for Pharmacyclics following speculation that the latter company was considering putting itself up for sale.

For related analysis, see ViewPoints: AbbVie acquires Pharmacyclics for $21 billion – the key questions.

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