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.