Zanubrutinib Versus Ibrutinib in Symptomatic Waldenström Macroglobulinemia: Final Analysis From the Randomized Phase III ASPEN Study
Dimopoulos, Meletios A; Opat, Stephen; D'Sa, Shirley; Jurczak, Wojciech; Lee, Hui-Peng; Cull, Gavin; Owen, Roger G; Marlton, Paula; Wahlin, Björn E; Garcia-Sanz, Ramon; McCarthy, Helen; Mulligan, Stephen; Tedeschi, Alessandra; Castillo, Jorge J; Czyz, Jaroslaw; Fernández de Larrea, Carlos; Belada, David; Libby, Edward; Matous, Jeffrey; Motta, Marina; Siddiqi, Tanya; Tani, Monica; Trněný, Marek; Minnema, Monique C; Buske, Christian; Leblond, Veronique; Treon, Steven P; Trotman, Judith; Chan, Wai Y; Schneider, Jingjing; Allewelt, Heather; Patel, Sheel; Cohen, Aileen; Tam, Constantine S
(2023) Journal of clinical oncology : official journal of the American Society of Clinical Oncology, volume 41, issue 33, pp. 5099 - 5106
(Article)
Abstract
The phase III ASPEN study demonstrated the comparable efficacy and improved safety of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia (WM). Here, we report long-term follow-up outcomes from ASPEN. The primary end point was the sum of very good partial response (VGPR) + complete response (CR) rates; secondary and
... read more
exploratory end points were also reported. Cohort 1 comprised 201 patients (myeloid differentiation primary response 88-mutant WM: 102 receiving zanubrutinib; 99 receiving ibrutinib); cohort 2 comprised 28 patients (myeloid differentiation primary response 88 wild-type WM: 28 zanubrutinib; 26 efficacy evaluable). At 44.4-month median follow-up, VGPR + CR rates were 36.3% with zanubrutinib versus 25.3% with ibrutinib in cohort 1 and 30.8% with one CR in cohort 2. In patients with CXC motif chemokine receptor 4 mutation, VGPR + CR rates were 21.2% with zanubrutinib versus 10.0% with ibrutinib (cohort 1). Median progression-free survival and overall survival were not reached. Any-grade adverse events (AEs) of diarrhea (34.7% v 22.8%), muscle spasms (28.6% v 11.9%), hypertension (25.5% v 14.9%), atrial fibrillation/flutter (23.5% v 7.9%), and pneumonia (18.4% v 5.0%) were more common with ibrutinib versus zanubrutinib; neutropenia (20.4% v 34.7%) was less common with ibrutinib versus zanubrutinib (cohort 1). Zanubrutinib was associated with lower risk of AE-related treatment discontinuation. Overall, these findings confirm the long-term response quality and tolerability associated with zanubrutinib.
show less
Download/Full Text
Keywords: Oncology, Cancer Research, Journal Article
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology
Note: Publisher Copyright: © American Society of Clinical Oncology.
(Peer reviewed)