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

作者：Lorenzo Falchi, Marcel Nijland, Huiqiang Huang, Kim Linton, John F. Seymour, Rong Tao, Michał Kwiatek, Abel Costa, Theodoros P. Vassilakopoulos, Richard Greil, Ana Jiménez Ubieto, Shane Gangatharan, Ohad Benjamini, Catherine Thieblemont, Alessandra Tucci, Anna Elinder-Camburn, Arpád Illés, Jan Novák, Miguel Arturo Pavlovsky, Andrew McDonald, Dok Hyun Yoon, Dai Maruyama, Gauri Sunkersett, Jian Mei, Nabanita Mukherjee, Feng Zhu, Abualbishr Alshreef, Elena Favaro, Franck Morschhauser, Panagiotis Tsirigotis, Juliana Torres Rodrigues Pereira, Sonia Gonzalez de Villambrosia, Jayr Schmidt Filho, I. Avivi, Wojciech Jurczak, Olivier Casasnovas, Juan Miguel Bergua Burgués, Jianzhen Shen, Neta Goldschmidt, Maria Bouzani, Zsolt Nagy, Loïc Ysebaert, Roch Houot, Benoît Tessoulin, Gandhi Damaj, Umberto Vitolo, Juan‐Manuel Sancho, Vinay Vanguru, Su‐Peng Yeh, Xiaojing Yan, Ashley Freeman, Jean-François Larouche, Szabolcs Modok, Caterina Patti, Joaquin Sanchez Garcia, Éderson Mattos, Patricia Walker, Jeong Ok Lee, Suguru Fukuhara, Yuko Mishima, Jie Jin, Zhengzi Qian, Russell Sterrett, Ronit Gurion, Natalia Rotter, David Belada, Kateřina Kopečková, Marek Trněný, Kamal Bouabdallah, Laure Lebras, Agathe Waultier, Stéphanie Guidez, Pierre Feugier, Enrico Derenzini, Gloria Margiotta Casaluci, Blanca Sánchez González, Javier López‐Jiménez, Nichole Gutierrez, Guillermo Rodriguez, A Caballero, Eva de Jongh, Wim Terpstra, Joost S.P. Vermaat, Tsai-Yun Chen, Hung-Lin Liu, Takayuki Ikezoe, Huijing Wu, Wenyu Li, Hongmei Jing, Adam S. Kittai, Catherine Diefenbach, Brad Hunter, Netanel A. Horowitz, Petra Pichler, Gábor Mikala, András Masszi, Ľuboš Drgoňa, Marie-Christine Ngirabacu, Ann Janssens, Romain Guièze, Éric Durot, Corinne Haïoun, Johannes Duell, Enrico Schalk, Monica Tani, A. Ramos, Raúl Córdoba Mascuñano, Carlos Grande García, Adolfo de la Fuente, Michael Roost Clausen, Troels Thomsen, Ingemar Lagerlöf, Inger S. Nijhof, Roderick J. Johnson, Directeur De, Ricardo Bigni, Hock Choong Lai, Samar Issa, Dong-Yeop Shin, Cheng‐Wei Chou, Hideki Goto, Takafumi Nakao, Caixia Li, Xiaolei Wei, Xudong Wei, Wenbin Qian, Shuo Ma, Vijayalakshmi Donthireddy, Catherine Diefenbach, Mark Fesler, Francisco J. Hernandez‐Ilizaliturri, Moshe Levy, Abhijeet Kumar, Habte Yimer, David Berz, Fernando Cabanillas, Maya Koren Michowitz, Muhıt Özcan, Ozan Salim, Güray Saydam, Mehmet Turgut, Özgür Mehtap, Mehmet Orhan Ayyıldız, Eirini Katodritou, Meletios Α. Dimopoulos, Péter Rajnics, Vanessa Van Hende, Renaud Roufosse, Inge Vrelust, Nadine Morineau, Sylvain Choquet, Emmanuel Bachy, Julie Abraham, Frank Kroschinsky, Carmen Herling, Marco Ladetto, Potito Rosario Scalzulli, Andrés J.M. Ferreri, Simone Ferrero, Stefan Hohaus, С. Каллерт, B Johansson, Rinske Boersma, Eduard Libourel, Clara Klerk, Matthew R. Wilson, Rebecca Auer, Shankaranarayana Paneesha, Toby Eyre, David Lewis, Robert Ayto, Wendy Osborne, Luciana Guanchiale, Hun Chuah, Anita Shetty, Chan Y. Cheah, Allanah Kilfoyle, Won Seog Kim, Ho‐Jin Shin, Tomoaki Fujisaki, Takahiro Kumode, Kenji Ishitsuka, Junichiro Yuda, Hisayuki Yokoyama, Koji Kato, Toshio Kitawaki, Tadakazu Kondo, Youko Suehiro, Yoshiaki Ogawa, Hideyuki Nakazawa, Akihiro Tomita, Hirotoshi Kamata, Xun Lai, Yue-Rong Shuang, Guangxun Gao, Lihong Liu, Haiyan Yang, Xinan Cen · 发表于：The Lancet · 年份：2025 · DOI：10.1016/s0140-6736(25)02360-8 · 被引用次数：16 · 研究领域：Lymphoma Diagnosis and Treatment、HER2/EGFR in Cancer Research、Cancer Immunotherapy and Biomarkers

Background An unmet need persists for chemotherapy-free regimens that induce durable responses for relapsed or refractory follicular lymphoma. Lenalidomide and rituximab (R 2 ) is an accepted standard of care in this population. The EPCORE FL-1 trial aimed to evaluate the efficacy and safety of epcoritamab plus R 2 versus R 2 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 R 2 or R 2 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 R 2 and 245 to R 2 . The trial m...