Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma Journal Article
| Authors: | Fraser, G. A. M.; Chanan-Khan, A.; Demirkan, F.; Santucci Silva, R.; Grosicki, S.; Janssens, A.; Mayer, J.; Bartlett, N. L.; Dilhuydy, M. S.; Loscertales, J.; Avigdor, A.; Rule, S.; Samoilova, O.; Pavlovsky, M. A.; Goy, A.; Mato, A.; Hallek, M.; Salman, M.; Tamegnon, M.; Sun, S.; Connor, A.; Nottage, K.; Schuier, N.; Balasubramanian, S.; Howes, A.; Cramer, P. |
| Article Title: | Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma |
| Abstract: | We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus ≤6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183–0.286]; p <.0001). Despite crossover of 63.3% of patients from the placebo plus BR arm to ibrutinib treatment upon disease progression, ibrutinib plus BR versus placebo plus BR demonstrated an overall survival benefit (HR 0.611 [95% CI 0.455–0.822]; p =.0010; median not reached in either arm). Long-term follow-up data confirm the survival benefit of ibrutinib plus BR over BR alone. Safety profiles were consistent with those known for ibrutinib and BR. © 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. |
| Keywords: | overall survival; 5-year follow-up; ibrutinib; helios phase 3 trial; relapsed chronic lymphocytic leukemia |
| Journal Title: | Leukemia and Lymphoma |
| Volume: | 61 |
| Issue: | 13 |
| ISSN: | 1042-8194 |
| Publisher: | Taylor & Francis Group |
| Date Published: | 2020-01-01 |
| Start Page: | 3188 |
| End Page: | 3197 |
| Language: | English |
| DOI: | 10.1080/10428194.2020.1795159 |
| PUBMED: | 32762271 |
| PROVIDER: | scopus |
| PMCID: | PMC9094431 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 4 January 2021 -- Source: Scopus |
