Real-World Study of Glofitamab for the Treatment of Relapse or Refractory Diffuse Large B-Cell Lymphoma in East China

Introduction: Glofitamab is a CD20×CD3 bispecific monoclonal antibody, with demonstrated efficacy and manageable safety for patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in clinical studies. In November 2023, glofitamab was approved by the China National Medical Products Administration (NMPA) for the treatment of R/R DLBCL. This study aimed to evaluate the efficacy and safety of glofitamab in the Chinese population in a real-world setting. Methods: We retrospectively enrolled R/R DLBCL patients who received at least 1 dose of glofitamab in 7 medical centers in east China from November 2023 to June 2024. We reported the objective response rate (ORR) and complete response (CR) rate based on Lugano criteria, and cytokine release syndrome (CRS) and immune effector cells-associated neurotoxicity syndrome (ICANS) based on ASTCT consensus 2019. Results: A total of 28 patients were included. At baseline (initiation of obinutuzumab pretreatment), the median age of patients was 63 years (range, 35-83), with 18 patients (64.3%) aged 60 years or older. 17 (60.7%) patients were male. 26 (92.9%) patients were diagnosed with DLBCL, not otherwise specified (including 2 primary central nervous system lymphoma (PCNSL) patients), 1 with high-grade B-cell lymphoma, and 1 with transformed follicular lymphoma. 10 (35.7%) patients had an ECOG score of 2-4, and 24 patients with Ann-Arbor stages III-IV. The median number of previous therapies was 2.5 (range, 1-6) and 82.1% (n=23) patients received 2 or more lines of previous therapies. 4 (14.3%) patients underwent autologous stem cell transplantation and 6 (21.4%) patients received CAR-T cell therapy. 10 (35.7%) patients had relapsed disease, and 12 (42.9%) were refractory to any prior therapy. Median follow up was 3 months. Patients received a median of 3 (1-12) cycles of glofitamab treatment and 16 patients were still under treatment atdata cutoff. Of the 24 patients evaluable for response, the ORR and CR rate was 62.5% and 25%, respectively. 2 PCNSL patients all responded. Median PFS and OS were not reached at data cutoff. The most common adverse event was CRS, which occurred in 39.3% of the patients with 2 patients having grade 3 events. No grade 4 CRS appeared. 1 patient developed grade 4 ICANS and was consequently deceased. Conclusions: This real-word study demonstrated that glofitamab has a consistent efficacy in Chinese R/R DLBCL patients as in previous clinical studies, with a lower incidence of adverse events. The actual CR rate might be higher since most patients were still under treatment.