Ibrutinib versus temsirolimus: 3-year follow-up of patients with previously treated mantle cell lymphoma from the phase 3, international, randomized, open-label RAY study

Mantle cell lymphoma (MCL) is an aggressive B-cell malignancy with a reported median overall survival (OS) of 3–5 years [ 1 ]. Most patients relapse after first-line therapy and have a poor prognosis [ 1 ]. Regulatory approval of ibrutinib has provided a much needed therapeutic option for patients with relapsed or refractory (R/R) MCL [ 2 ], with ibrutinib becoming a preferred standard of care in current guidelines [ 3 , 4 ]. The randomized, open-label phase 3 RAY study (NCT01646021) was key in confirming the efficacy and safety of ibrutinib, with ibrutinib ( N = 139) showing significantly improved progression-free survival (PFS) versus temsirolimus ( N = 141) (primary analysis [20-month follow-up]: 14.6 vs. 6.2 months, hazard ratio [HR] 0.43, 95% confidence interval [CI]: 0.32–0.58) [ 5 ]. Here, we report extended follow-up data from the final analysis of the RAY study.