| Title: |
Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial |
| Authors: |
Falchi, Lorenzo; Nijland, Marcel; Huang, Huiqiang; Linton, Kim M; Seymour, John F; Tao, Rong; Kwiatek, Michal; Costa, Abel; Vassilakopoulos, Theodoros P; Greil, Richard; Jiménez-Ubieto, Ana; Gangatharan, Shane A; Benjamini, Ohad; Thieblemont, Catherine; Tucci, Alessandra; Elinder-Camburn, Anna; Illes, Arpad; Novak, Jan; Pavlovsky, Miguel A; McDonald, Andrew; Yoon, Dok Hyun; Maruyama, Dai; Sunkersett, Gauri; Mei, Jian P; Mukherjee, Nabanita; Zhu, Feng; Alshreef, Abualbishr; Favaro, Elena; Morschhauser, Franck; Tsirigotis, Panagiotis; Pereira, Juliana; Gonzalez de Villambrosia, Sonia; Schmidt Filho, Jayr; Avivi, Irit; Jurczak, Wojciech; Casasnovas, Olivier; Miguel Bergua Burgues, Juan; Shen, Jianzhen; Goldschmidt, Neta; Bouzani, Maria; Nagy, Zsolt; Ysebaert, Loic; Houot, Roch; Tessoulin, Benoit; Laurent Damaj, Gandhi; Vitolo, Umberto; Manuel Sancho, Juan; Vanguru, Vinay; Yeh, Su-Peng; Yan, Xiaojing; Freeman, Ashley; Larouche, Jean-Francois; Modok, Szabolcs; Patti, Caterina; Sanchez Garcia, Joaquin; Roberto de Mattos, Ederson; Walker, Patricia; Ok Lee, Jeong; Fukuhara, Suguru; Mishima, Yuko; Jin, Jie; Qian, Zhengzi; Sterrett, Russell; Gurion, Ronit; Rotter, Natalia; Belada, David; Kopeckova, Katerina; Trneny, Marek; Bouabdallah, Kamal; LeBras, Laure; Waultier, Agathe; Guidez, Stephanie; Feugier, Pierre; Derenzini, Enrico; Margiotta Casaluci, Gloria; Sanchez Gonzalez, Blanca; Lopez Jiménez, Javier; Gutierrez Gutierrez, Norma; Rodriguez, Guillermo; Carolina Caballero Gonzalez, Ana; de Jongh, Eva; Terpstra, Wim; Vermaat, Joost; Chen, Tsai-Yun; Liu, Hung-Lin; Ikezoe, Takayuki; Wu, Huijing; Li, Wenyu; Jing, Hongmei; Kittai, Adam; Diefenbach, Catherine; Hunter, Brad; Horowitz, Netanel; Pichler, Petra; Mikala, Gabor; Masszi, Andras; Drgona, Lubos; Ngirabacu, Marie-Christine; Janssens, Ann; Guieze, Romain; Durot, Eric; Haioun, Corinne; Duell, Johannes; Schalk, Enrico; Tani, Monica; Carla Oliveira Ramos, Ana; Cordoba Mascunano, Raul; Grande Garcia, Carlos; de la Fuente, Adolfo; Roost Clausen, Michael; Thomsen, Troels; Lagerlof, Ingemar; Nijhof, Inger; Johnson, Roderick; Leao Cordeiro de, Danielle; Bigni, Ricardo; Choong Lai, Hock; Issa, Samar; Shin, Dong-Yeop; Chou, Cheng-Wei; Goto, Hideki; Nakao, Takafumi; Li, Caixia; Wei, Xiaolei; Wei, Xudong; Qian, Wenbin; Ma, Shuo; Donthireddy, Vijayalakshmi; Fesler, Mark; Hernandez-Ilizaliturri, Francisco; Levy, Moshe; Kumar, Abhijeet; Yimer, Habte; Berz, David; Cabanillas, Fernando; Koren Michowitz, Maya; Ozcan, Muhit; Salim, Ozan; Saydam, Guray; Turgut, Mehmet; Mehtap, Ozgur; Orhan Ayyildiz, Mehmet; Katodritou, Eirini; Dimopoulos, Meletios-Athanasios; Rajnics, Peter; Van Hende, Vanessa; Roufosse, Renaud; Vrelust, Inge; Morineau, Nadine; Choquet, Sylvain; Bachy, Emmanuel; Abraham, Julie; Kroschinsky, Frank; Herling, Carmen; Ladetto, Marco; Scalzulli, Potito; Ferreri, Andres; Ferrero, Simone; Hohaus, Stefan; Kallert, Stefan; Johansson, Berit; Boersma, Rinske; Libourel, Eduard; Klerk, Clara; Wilson, Matthew; Auer, Rebecca; Paneesha, Shankaranarayana; Eyre, Toby; Lewis, David; Ayto, Robert; Osborne, Wendy; Andrea Guanchiale, Luciana; Chuah, Hun; Shetty, Anita; Cheah, Chan; Kilfoyle, Allanah; Seog Kim, Won; Shin, Ho-Jin; Fujisaki, Tomoaki; Kumode, Takahiro; Ishitsuka, Kenji; Yuda, Junichiro; Yokoyama, Hisayuki; Kato, Koji; Kitawaki, Toshio; Kondo, Tadakazu; Suehiro, Youko; Ogawa, Yoshiaki; Nakazawa, Hideyuki; Tomita, Akihiro; Kamata, Hirotoshi; Lai, Xun; Shuang, Yuerong; Gao, Guangxun; Liu, Lihong; Yang, Haiyan; Cen, XiNan |
| Publisher Information: |
Elsevier |
| Publication Year: |
2026 |
| Collection: |
University of Glasgow: Enlighten - Publications |
| Description: |
Background: An unmet need persists for chemotherapy-free regimens that induce durable responses for relapsed or refractory follicular lymphoma. Lenalidomide and rituximab (R²) is an accepted standard of care in this population. The EPCORE FL-1 trial aimed to evaluate the efficacy and safety of epcoritamab plus R² versus R² in participants with relapsed or refractory follicular lymphoma after at least one previous line of chemoimmunotherapy. Methods: In this multicountry, open-label, phase 3 trial, participants were randomly allocated (1:1) to fixed-duration epcoritamab plus R² or R² for up to 12 cycles. Epcoritamab was administered weekly in cycles 1–3 and every 4 weeks in cycles 4–12, lenalidomide once daily during cycles 1–12 (days 1–21), and rituximab weekly during cycle 1 and monthly in cycles 2–5. The dual primary endpoints were overall response rate and progression-free survival by independent review committee. The data reported here are from a planned interim analysis carried out after 78% of progression-free survival events had occurred. This study is registered with ClinicalTrials.gov, NCT05409066, and EudraCT, 2021–000169–34, and is ongoing (closed to recruitment). Findings: Out of 668 participants screened for eligibility across 189 academic and non-academic centres in 30 countries across Africa, Asia, Australia, Europe, North America, and South America, a total of 488 participants were randomly allocated, 243 to epcoritamab plus R² and 245 to R². The trial met its dual primary endpoints, showing superiority of epcoritamab plus R² over R² in overall response rate and progression-free survival. With a median follow-up of 14·8 months (IQR 11·4–19·0), overall response rate was 95% (95% CI 92–97) with epcoritamab plus R² versus 79% (74–84; p |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://eprints.gla.ac.uk/381020/1/381020.pdf; Falchi, L. et al. (2026) Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. Lancet , 407(10524), pp. 161-173. (doi:10.1016/S0140-6736(25)02360-8 ) (PMID:41371238) |
| Availability: |
https://eprints.gla.ac.uk/381020/; https://eprints.gla.ac.uk/381020/1/381020.pdf |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.F352A752 |
| Database: |
BASE |