TY - JOUR
T1 - Phase 3 SELENE study
T2 - ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma
AU - Nastoupil, Loretta J.
AU - Hess, Georg
AU - Pavlovsky, Miguel A.
AU - Danielewicz, Iwona
AU - Freeman, Jane
AU - García-Sancho, Alejandro Martin
AU - Glazunova, Valeria
AU - Grigg, Andrew
AU - Hou, Jing Zhou
AU - Janssens, Ann
AU - Kim, Seok Jin
AU - Masliak, Zvenyslava
AU - McKay, Pam
AU - Merli, Francesco
AU - Munakata, Wataru
AU - Nagai, Hirokazu
AU - Özcan, Muhit
AU - Preis, Meir
AU - Wang, Tingyu
AU - Rowe, Melissa
AU - Tamegnon, Monelle
AU - Qin, Rui
AU - Henninger, Todd
AU - Curtis, Madeliene
AU - Caces, Donne Bennett
AU - Thieblemont, Catherine
AU - Salles, Gilles
N1 - Publisher Copyright:
© 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.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85178334364
U2 - 10.1182/bloodadvances.2023010298
DO - 10.1182/bloodadvances.2023010298
M3 - Article
C2 - 37722354
AN - SCOPUS:85178334364
SN - 2473-9529
VL - 7
SP - 7141
EP - 7150
JO - Blood Advances
JF - Blood Advances
IS - 22
ER -
