Acalabrutinib (Acala) versus idelalisib plus rituximab (IdR) or bendamustine plus rituximab (BR) in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): ASCEND final results
| Autor: | Philip Campbell, Polina Kaplan, Gerardo Musuraca, Jae Hoon Lee, Paolo Ghia, Sean Dolan, Abraham Jacob, Andrzej Pluta, Martin Simkovic, Tomas Kozak, Denise Wang, Wojciech Jurczak, Priti Patel, Árpád Illés, Iryna Kraychok, Eric J. Avery, Cheng Seok Quah, Malgorzata Wach, Daniel Lysák, Javier de la Serna |
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| Rok vydání: | 2020 |
| Předmět: |
Bendamustine
Cancer Research biology business.industry Chronic lymphocytic leukemia medicine.disease Highly selective 03 medical and health sciences 0302 clinical medicine Oncology 030220 oncology & carcinogenesis Relapsed refractory Cancer research biology.protein Medicine Acalabrutinib Bruton's tyrosine kinase Rituximab business Idelalisib 030215 immunology medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 38:8015-8015 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2020.38.15_suppl.8015 |
| Popis: | 8015 Background: Acala is a next-generation, highly selective, covalent Bruton tyrosine kinase inhibitor approved for patients (pts) with CLL including those with R/R CLL. The efficacy and safety of acala alone vs IdR or BR were shown in R/R CLL pts in a preplanned interim analysis of ASCEND; final results are reported herein. Methods: In this randomized, multicenter, phase 3, open-label study (NCT02970318), R/R CLL pts were randomized 1:1 to receive oral (PO) acala 100 mg BID or investigator’s (INV) choice of IdR (Id: 150 mg PO BID until progression or toxicity; R: 375 x1 then 500 mg/m2 intravenously [IV] for 8 total infusions) or BR (B: 70 mg/m2 IV and R: 375 x1 then 500 mg/m2 IV for 6 total cycles) until progression or toxicity. Progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and safety were assessed. Results: 310 pts (acala, n=155; IdR, n=119; BR, n=36) were enrolled (median age: 67 y; del(17p) 16%, del(11q) 27%, Rai stage 3/4 42%). At a median follow-up of 22.0 m, acala significantly prolonged INV-assessed PFS vs IdR/BR (median: not reached vs 16.8 m; hazard ratio: 0.27, P |
| Databáze: | OpenAIRE |
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