AbbVie announced Thursday that a Phase III study investigating Imbruvica (ibrutinib) in combination with Roche's Gazyva (obinutuzumab) in previously untreated patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) met its primary endpoint of a significant improvement in progression-free survival (PFS) versus Gazyva plus chlorambucil. "Based on the data, and if approved by the FDA, Imbruvica plus [Gazyva] could be the first chemotherapy-free CD20 combination in first-line CLL treatment," AbbVie noted.
In the iLLUMINATE trial, patients with previously untreated CLL or SLL were randomised to receive Gazyva in combination with either Imbruvica or chlorambucil. In addition to the primary endpoint of PFS as assessed by an independent review committee, key secondary goals included overall response rate and rate of minimal residual disease-negative responses.
AbbVie, whose Pharmacyclics subsidiary jointly develops and commercialises Imbruvica with Johnson & Johnson's Janssen Biotech unit, said the companies plan to share the preliminary analysis of the study with regulatory authorities. The drugmaker also indicated that the iLLUMINATE data will be submitted for publication or for presentation at a research conference. "We are optimistic about the topline results," remarked Danelle James, head of clinical science at Pharmacyclics, noting that the combination of Gazyva plus chlorambucil "is currently recommended by the National Comprehensive Cancer Network guidelines as a Category 1 treatment." She added that "we are committed to researching the full potential of Imbruvica alone and in combination therapy across a range of B-cell blood cancers."
FirstWord reports in this therapy area - KOL Insight Chronic Lymphocytic Leukaemia (CLL): Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Imbruvica was initially cleared in the US in 2013 for the treatment of patients with previously treated mantle cell lymphoma. It was later authorised for use in patients with CLL who received at least one prior therapy, as well as for patients with previously treated CLL who carry the 17p deletion, which is associated with poor treatment outcomes.
The BTK inhibitor was also approved by the FDA in 2015 for the treatment of Waldenstrom's macroglobulinaemia, and last year for chronic graft-versus-host disease after failure of one or more treatments. AbbVie gained rights to Imbruvica as part of its purchase of Pharmacyclics for $21 billion in 2015.
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