A combination of AbbVie/Johnson & Johnson’s Imbruvica and Roche’s Gazyva has taken a step closer to becoming first chemotherapy-free CD20 combination for first-line treatment of chronic lymphocytic leukaemia (CLL), after showing promise in a late-stage clinical trial.
The Phase III iLLUMINATE trial assessed Imbruvica (ibrutinib) in combination with Gazyva (obinutuzumab) compared to chlorambucil/Gazvya in patients with previously untreated CLL or small lymphocytic lymphoma (SLL).
The study met its primary endpoint showing that the Imbruvica plus Gazyva regimen significantly improved progression-free survival versus the comparator arm, as assessed by an Independent Review Committee.
"We are optimistic about the topline results from the iLLUMINATE study and the fact that Imbruvica plus obinutuzumab demonstrated marked improvement in progression-free survival compared to obinutuzumab plus chlorambucil, a combination which is currently recommended by the National Comprehensive Cancer Network guidelines as a Category 1 treatment," said Danelle James, head of Clinical Science at Pharmacyclics, an AbbVie company.
Pharmacyclics and Janssen said they are sharing the primary analysis data from the study with regulatory authorities, in the hope of widening the first-in-class Bruton's tyrosine kinase (BTK) inhibitor’s first-line label.
Imbruvica was first launched in the US in November 2013, and is now approved in the region for six disease indications, including for frontline CLL treatment, for adult CLL patients who have received at least one prior therapy, and for those with 17p deletion.