Multinational phase 3 trial of first-line immunochemotherapy with or without ibrutinib with or without autoSCT in younger MCL patients

The phase 3 TRIANGLE trial, in 13 European countries and Israel, randomized younger (aged 65 years or younger) patients with previously untreated mantle cell lymphoma to standard immunochemotherapy followed by autoSCT (group A), addition of ibrutinib to this treatment during induction and as maintenance fro two years (group A+I), or standard immunochemotherapy plus ibrutinib without autoSCT (group I). For the primary endpoint failure-free survival, A+I was superior to A, while superiority of A over I was not shown. Comparison of A+I versus I is ongoing. Three-year overall survival was 86% in group A, 91% in group A+I, and 92% in group I. Ibrutinib during maintenance was associated with substantial toxicity. The authors conclude that adding ibrutinib to first-line treatment resulted in superior efficacy in younger MCL patient with increased toxicity in the maintenance phase.