ASH 2020 | iNNOVATE study update: long-term PFS in WM

Meletios Dimopoulos, MD, University of Athens School of Medicine, Athens, Greece, presents data from the Phase III iNNOVATE study (NCT02165397) evaluating the long-term follow-up of ibrutinib plus rituximab in patients with Waldenström’s macroglobulinemia (WM). Earlier study data showed that combined ibrutinib and rituximab resulted in superior progression-free survival compared to placebo plus rituximab. In this extended follow-up analysis, with a median follow-up of 50 months, ibrutinib continued to be superior with regards to PFS. In the ibrutinib-rituximab arm, the median PFS was not reached, versus 20.3 months in the placebo-rituximab arm. The superiority was consistent regardless of genotype, prior treatment and patient characteristics. Ibrutinib treatment also significantly improved the overall response rate. No new safety signals were identified at this analysis. An open-label sub-study trialed ibrutinib monotherapy in rituximab-refractory WM and long-term follow-up showed significant maintained efficacy across all genotypes in this heavily pretreated population. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.