AbbVie and Johnson & Johnson announced Tuesday results from an interim analysis of a Phase III study presented at the American Society of Hematology (ASH) annual meeting, which showed that the combination of Imbruvica (ibrutinib) and Roche's Rituxan (rituximab) achieved a 65-percent reduction in risk of disease progression or death versus standard of care in patients aged 70 and younger with newly diagnosed chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). Danelle James, head of science at AbbVie's Pharmacyclics unit, stated "these findings further support Imbruvica-based therapy as an efficacious first-line treatment for many patients with CLL."
In the E1912 study, 529 patients with newly diagnosed CLL or SLL were randomised to treatment with Imbruvica plus Rituxan or standard of care consisting of Rituxan, fludarabine and cyclophosphamide. The primary endpoint of the study was progression-free survival (PFS), while the key secondary endpoint was overall survival (OS).
The drugmakers noted that after a median follow-up of 33.4 months, subgroup analysis illustrated that the combination of Imbruvica and Rituxan was associated with improvements in PFS irrespective of age, sex, performance status or deletion of 11q23. Additionally, the regimen was linked to a significant improvement in OS.
Imbruvica was initially cleared in the US in 2013 for previously treated patients with mantle cell lymphoma. Most recently, the therapy was authorised for use in combination with Rituxan for the treatment of Waldenström's macroglobulinaemia.
Johnson & Johnson and AbbVie jointly market Imbruvica, with the latter drugmaker gaining rights to the drug via its acquisition of Pharmacyclics for about $21 billion in 2015.
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