Real-world outcomes of glofitamab therapy in CAR-T naive patients with relapsed/refractory B-cell lymphoma

作者：Liudmila Fedorova, Nataliia Mikhailova, Kirill V. Lepik, Vladislav Markelov, Andrey Chekalov, Olesya Smykova, Gayane Tumyan, Anastasia Semenova, Arman Arakelyan, Lev S. Butaev, I I Oleĭnik, Evgeny Nikitin, В. В. Птушкин, Yana Mangasarova, Aminat Magomedova, E. A. Gitelzon, Н. Г. Габеева, Daria Koroleva, Anna Smolyaninova, Е. Е. Звонков, Iurii Osipov, Natalia Stepanova, Tatiana Krinitsina, Yu. E. Ryabukhina, Gulnara N. Khusainova, Leisan Mukharliamova, Olga A. Smirnova, I. Ishmatova, Anna Zverkova, S. Elkhova, Stanislav Volchenkov, Ilya Ziuzgin, Diana Ivanova, Е. А. Baryakh, E. N. Misyurina, P. A. Zeynalovа, Firusa Abbasbeyli, Olga Timofeeva, Iulia Podmankova, М. В. Ульянова, Victoria Basmanova, Tatiana Tsyganok, Svetlana Samarina, Valeria Kimaikina, Ekaterina Zubkova, Svetlana Ovanesian, Alsou Iskhakova, Aleksei Kuvshinov, Anastasiya Kuzyaeva, Galiya Isaeva, Maria Andrievskih, Olga Arzhanukhina, Polina Makarovskaya, Olga Samoylova, Irina Vasileva, A. Yu. Terekhova, Н. А. Фалалеева, Vasily Shuvaev, S.A. Vlasova, Valery Lapin, В. И. Бахтина, Alexander Kulagin · 发表于：Blood · 年份：2025 · DOI：10.1182/blood-2025-1961 · 被引用次数：1 · 研究领域：CAR-T cell therapy research、Monoclonal and Polyclonal Antibodies Research、Virus-based gene therapy research

Abstract Background The bispecific antibody (BsAb) glofitamab (G) has demonstrated high efficacy and acceptable feasibility in patients with aggressive relapsed/refractory (r/r) B-cell lymphoma in clinical trials. However, real-world evidence on its use remains limited, particularly in the context of evolving immunotherapy options and their sequencing. Here we report outcomes of glofitamab in CAR-T naive patients from a compassionate use program (CUP) and routine clinical practice. Materials and methods This multicenter retrospective study included CAR-T naive patients with r/r B-cell lymphoma who were treated with G within CUP or routine clinical practice in 22 Russian centers. Glofitamab was administered according to the approval study. The analysis included evaluation of overall response (ORR) and complete response (CR) rate, overall survival (OS), progression-free survival (PFS). We assessed the impact of clinical factors on CR achievement and PFS, along with characterization of adverse events (AEs). Results As of July 2025, 152 patients were enrolled. Median age at G initiation was 51 (19-83), male/female ratio - 72/80 (47/53%). The study population included patients with diffuse large B-cell lymphoma, both de novo and transformed (n=88, 58%), high-grade B-cell lymphoma (n=17, 11%), primary mediastinal large B-cell lymphoma (n=20, 13%), follicular large B-cell lymphoma (n=9, 6%) and other lymphomas (n=18, 12%). Median number of therapy lines before G was 3 (3-9). Overall...