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Title: Phase 3 SELENE Study: Ibrutinib Plus BR/R-CHOP in Previously Treated Patients with Follicular or Marginal Zone Lymphoma.
Austin Authors: Nastoupil, Loretta J;Hess, Georg;Pavlovsky, Miguel Arturo;Danielewicz, Iwona;Freeman, Jane A;Martin Garcia-Sancho, Alejandro;Glazunova, Valeria;Grigg, Andrew P ;Hou, Jing-Zhou;Janssens, Ann;Kim, Seok-Jin;Masliak, Zvenyslava;McKay, Pamela;Merli, Francesco;Munakata, Wataru;Nagai, Hirokazu;Özcan, Muhit;Preis, Meir;Wang, Tingyu;Rowe, Melissa;Tamegnon, Monelle;Qin, Rui;Henninger, Todd;Curtis, Madeliene;Caces, Donne Bennett;Thieblemont, Catherine;Salles, Gilles A
Affiliation: UT MD Anderson Cancer Center, Houston, Texas, United States.
Johannes Gutenberg-Universität Mainz, Mainz, Germany.
FUNDALEU, Clinical research center Buenos Aires, Argentina, Buenos Aires, Argentina.
Szpitale Pomorskie Sp z o.o., Gdynia, Poland.
Sydney Adventist Hospital, Wahroonga, Australia.
Hospital Universitario de Salamanca, Salamanca, Spain.
S.P. Botkin City Clinical Hospital, Moscow, Russian Federation.
Austin Health
University of Pittsburgh, Pittsburgh, Pennsylvania, United States.
Department of Hematology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium., Leuven, Belgium.
Samsung Medical Center, Seoul, Korea, Republic of.
Institute of Blood Pathology and Transfusion Medicine, Lviv, Ukraine.
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.
Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
National Cancer Center Hospital, Tokyo, Japan.
National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Ankara University School of Medicine, Ankara, Turkey.
Lady Davis Carmel Medical Center, Haifa, Israel.
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union, Tian Jin, China.
Janssen Research & Development, High Wycombe, United Kingdom.
Janssen Research & Development, Raritan, New Jersey, United States.
Assistance Publique des Hopitaux de Paris, Paris, France.
Memorial Sloan Kettering Cancer Center, New York, New York, United States.
Issue Date: 18-Sep-2023
Date: 2023
Publication information: Blood Advances 2023-09-18
Abstract: The phase 3 SELENE study evaluated ibrutinib + chemoimmunotherapy (CIT; bendamustine and rituximab [BR] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) in 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 six cycles of BR/R-CHOP. Primary endpoint 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] [95% CI], 0.806 [0.626-1.037]; P = .0922). Median overall survival was not reached in either arm (HR [95% CI], 0.980 [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 to placebo + CIT. The safety profile was consistent with known profiles of ibrutinib and CIT. This trial was registered at as # NCT01974440.
DOI: 10.1182/bloodadvances.2023010298
ORCID: 0000-0001-6071-8610
Journal: Blood Advances
PubMed URL: 37722354
ISSN: 2473-9537
Type: Journal Article
Appears in Collections:Journal articles

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