Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Elevate-TN four-year follow up

Autor: John C. Byrd, Laura Fogliatto, Priti Patel, Ann Janssens, Jeff Porter Sharman, Karin Karlsson, Patricia F. Walker, William G. Wierda, John M. Pagel, Alan P Skarbnik, Gillian Corbett, Min Hui Wang, Versha Banerji, Talha Munir, Paolo Ghia, S. E. Coutre, Miklos Egyed, Yair Herishanu, Wojciech Jurczak, Manali Kamdar
Rok vydání: 2021
Předmět:
Zdroj: Journal of Clinical Oncology. 39:7509-7509
ISSN: 1527-7755
0732-183X
Popis: 7509 Background: Early results from ELEVATE-TN (NCT02475681) at a median follow-up of 28.3 mo demonstrated superior efficacy of acalabrutinib (A) ± obinutuzumab (O) compared with O + chlorambucil (Clb) in patients (pts) with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) (Sharman et al. Lancet 2020;395:1278-91). Results from a 4-year update are reported here. Methods: Pts received A±O or O+Clb. Crossover to A monotherapy was permitted in pts who progressed on O+Clb. Investigator-assessed (INV) progression-free survival (PFS), INV overall response rate (ORR), overall survival (OS), and safety were evaluated. Results: 535 pts (A+O, n=179; A, n=179; O+Clb, n=177) were randomized with a median age of 70 y; 63% had unmutated IGHV and 9% del(17p). At a median follow-up of 46.9 mo (range, 0.0–59.4; data cutoff: Sept 11, 2020), the median PFS was not reached (NR) for A+O and A pts vs 27.8 mo for O+Clb pts (both P
Databáze: OpenAIRE