Phase 3 SELENE study: Ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma Journal Article
| Authors: | Nastoupil, L. J.; Hess, G.; Pavlovsky, M. A.; Danielewicz, I.; Freeman, J.; García-Sancho, A. M.; Glazunova, V.; Grigg, A.; Hou, J. Z.; Janssens, A.; Kim, S. J.; Masliak, Z.; McKay, P.; Merli, F.; Munakata, W.; Nagai, H.; Özcan, M.; Preis, M.; Wang, T.; Rowe, M.; Tamegnon, M.; Qin, R.; Henninger, T.; Curtis, M.; Caces, D. B.; Thieblemont, C.; Salles, G. |
| Article Title: | Phase 3 SELENE study: Ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma |
| Abstract: | The phase 3 SELENE study evaluated ibrutinib + chemoimmunotherapy (CIT; bendamustine and rituximab [BR]; or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for patients with relapsed/refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL). Adult patients who had received ≥1 prior line of CIT were randomized 1:1 to oral ibrutinib (560 mg) or placebo daily, plus 6 cycles of BR/R-CHOP. The primary end point was investigator-assessed progression-free survival (PFS). Overall, 403 patients were randomized to ibrutinib + CIT (n = 202) or placebo + CIT (n = 201). Most patients received BR (90.3%) and had FL (86.1%). With a median follow-up of 84 months, median PFS was 40.5 months in the ibrutinib + CIT arm and 23.8 months in the placebo + CIT arm (hazard ratio [HR], 0.806; 95% confidence interval [CI], 0.626-1.037; P = .0922). Median overall survival was not reached in either arm (HR, 0.980; 95% CI, 0.686-1.400). Grade ≥3 treatment-emergent adverse events (TEAEs) were reported in 85.6% and 75.4% of patients in the ibrutinib + CIT and placebo + CIT arms, respectively. In each arm, 13 patients had TEAEs leading to death. The addition of ibrutinib to CIT did not significantly improve PFS compared with placebo + CIT. The safety profile was consistent with known profiles of ibrutinib and CIT. © 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved. |
| Keywords: | adult; cancer chemotherapy; cancer survival; controlled study; aged; major clinical study; overall survival; fatigue; neutropenia; cancer recurrence; placebo; diarrhea; drug efficacy; drug safety; drug withdrawal; cancer patient; rituximab; follow up; cancer immunotherapy; progression free survival; multiple cycle treatment; ovary cancer; anemia; nausea; randomized controlled trial; thrombocytopenia; vomiting; lung cancer; bendamustine; bladder cancer; coughing; fever; pneumonia; rash; hypotension; heart failure; multicenter study; sepsis; phase 3 clinical trial; double blind procedure; follicular lymphoma; marginal zone lymphoma; aspergillosis; respiratory tract infection; upper respiratory tract infection; decreased appetite; septic shock; patient-reported outcome; ischemic stroke; ibrutinib; human; male; female; article; nocardiosis; cyclophosphamide plus doxorubicin plus prednisolone plus rituximab plus vincristine |
| Journal Title: | Blood Advances |
| Volume: | 7 |
| Issue: | 22 |
| ISSN: | 2473-9529 |
| Publisher: | American Society of Hematology |
| Date Published: | 2023-11-28 |
| Start Page: | 7141 |
| End Page: | 7150 |
| Language: | English |
| DOI: | 10.1182/bloodadvances.2023010298 |
| PUBMED: | 37722354 |
| PROVIDER: | scopus |
| PMCID: | PMC10709678 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
