Christian Buske, MD, discusses the results of the iNNOVATE trial in Waldenström macroglobulinemia.
Christian Buske, MD, director, Institute of Experimental Cancer Research, attending physician, professor of medicine, Medical Department for Internal Medicine III, Hematology/Oncology, University Hospital Ulm, Ulm, Germany, discusses the results of the iNNOVATE trial in Waldenström macroglobulinemia (WM).
Updated results of the randomized, phase 3 iNNOVATE trial, which were presented during the 2020 ASH Annual Meeting & Exposition, showed that there were no new safety signals with the combination of ibrutinib (Imbruvica) and rituximab (Rituxan). Minimaldifferences in adverse effect (AE) rates were observed after 24 months of additional follow-up, Buske explains. The most common grade 3 or 4 AEs included atrial fibrillation, hypertension, neutropenia, and anemia. At study conclusion, 68 patients remained on treatment.
Regarding efficacy, the median progression-free survival was not reached with the combination of ibrutinib plus rituximab compared with 20.3 months with rituximab alone, thus meeting the primary end point of the study, Buske adds.
Notably, the combination of ibrutinib plus rituximab demonstrated ongoing superiority vs rituximab monotherapy across clinical outcomes in patients with WM, irrespective of genotype, prior treatment, and key patient characteristics, Buske concludes.