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Nastoupil, Loretta J.; Hess, Georg; Pavlovsky, Miguel A.; Danielewicz, Iwona; Freeman, Jane; García-Sancho, Alejandro Martin; Glazunova, Valeria; Grigg, Andrew; Hou, Jing-Zhou; Janssens, Ann; Kim, Seok Jin; Masliak, Zvenyslava; McKay, Pam; Merli, Francesco; Munakata, Wataru; Nagai, Hirokazu; Özcan, Muhit; Preis, Meir; Wang, Tingyu; Rowe, Melissa; Tamegnon, Monelle; Qin, Rui; Henninger, Todd; Curtis, Madeliene; [...]

Phase 3 SELENE study: ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma

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  • Medientyp: E-Artikel
  • Titel: Phase 3 SELENE study: ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma
  • Beteiligte: Nastoupil, Loretta J.; Hess, Georg; Pavlovsky, Miguel A.; Danielewicz, Iwona; Freeman, Jane; García-Sancho, Alejandro Martin; Glazunova, Valeria; Grigg, Andrew; Hou, Jing-Zhou; Janssens, Ann; Kim, Seok Jin; Masliak, Zvenyslava; McKay, Pam; Merli, Francesco; Munakata, Wataru; Nagai, Hirokazu; Özcan, Muhit; Preis, Meir; Wang, Tingyu; Rowe, Melissa; Tamegnon, Monelle; Qin, Rui; Henninger, Todd; Curtis, Madeliene; [...]
  • Erschienen: American Society of Hematology, 2023
  • Erschienen in: Blood Advances
  • Sprache: Englisch
  • DOI: 10.1182/bloodadvances.2023010298
  • ISSN: 2473-9529; 2473-9537
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:p>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. This trial was registered at www.clinicaltrials.gov as #NCT01974440.</jats:p>
  • Zugangsstatus: Freier Zugang