Single-Agent Ibrutinib for Rituximab-Refractory Waldenström Macroglobulinemia: Final Analysis of the Substudy of the Phase III InnovateTM Trial.

Purpose: The first report from the open-label substudy of the phase III iNNOVATE study (PCYC-1127; NCT02165397) demonstrated that single-agent ibrutinib was efficacious and well tolerated in patients with heavily pretreated, rituximab-refractory Waldenstrom9s macroglobulinemia (WM). Results from the final analysis are now reported. Experimental Design: Ibrutinib 420 mg was administered once daily to patients (N=31) who failed to achieve at least a minor response (MR) or who relapsed