Abstract Background: Patients with relapsed or refractory (R/R) aggressive B-cell lymphomas, particularly diffuse large B-cell lymphoma (DLBCL), have a poor prognosis. Glofitamab, a CD20xCD3 bispecific antibody, has demonstrated significant efficacy in pivotal clinical trials. However, a pressing need exists for real-world evidence on its effectiveness and safety, especially within heavily pre-treated and heterogeneous patient populations. This study aimed to evaluate the outcomes of glofitamab-based therapy in a real-world cohort of Chinese patients with R/R aggressive B-cell lymphomas and to identify predictive factors for response. Methods: This retrospective, multicenter study enrolled 65 patients with R/R aggressive B-cell lymphoma treated with glofitamab-based regimens. We collected baseline demographic, clinical, and treatment data. The majority of patients received glofitamab as monotherapy (50.8%) or in combination with PD-1 inhibitors (27.7%). Primary efficacy endpoints were the overall response rate (ORR) and complete response (CR) rate. Survival outcomes, including progression-free survival (PFS) and overall survival (OS), were analyzed using the Kaplan-Meier method. Safety was evaluated based on reported adverse events (AEs). Univariate logistic regression analyses were performed to identify predictors for achieving a CR. Results: A total of 65 patients were included in the analysis. The cohort was characterized by high-risk features: 72.3% were older than 60 years, 80.7% had Ann Arbor stage III-IV disease, the median treatment line 4 (range 2-11), and 50.9% had refractory disease. The predominant histology was DLBCL (83.1%), with 67.2% being of the non-germinal center B-cell (non-GCB) subtype. Among 43 efficacy-evaluable patients, the best ORR was 67.4% (95% CI: 51.5%-80.9%), with a CR rate of 46.5%. For the 39 patients in the survival analysis, the median follow-up was 5.88 months (95% CI: 4.24-9.86). The median progression-free survival (PFS) was 6.0 months (95% CI: 4.3-NA) , and the median overall survival (OS) was 13.9 months (95% CI: 12.5-NA). The treatment was well-tolerated, with the most frequent grade ≥3 AEs being anemia (18.2%), neutropenia (15.9%), and leukopenia (13.6%). Cytokine release syndrome (CRS) occurred in 18.2% of patients, and was predominantly low-grade. Severe, grade ≥3 CRS was observed in only 4.5% of patients. Univariate analysis revealed that relapsed disease (vs. refractory, OR=5.06, p=0.020) and the absence of bone marrow involvement (OR=4.44, p=0.039) were associated with a higher likelihood of achieving CR.Conclusion: In this multicenter, real-world study of Chinese patients with R/R aggressive B-cell lymphoma, glofitamab-based therapy demonstrated substantial efficacy, achieving high response rates and promising survival outcomes. At the same time, the safety profile was predictable and manageable, with a low incidence of severe CRS. Our findings suggest that glofitamab is a valuable therapeutic option for this challenging patient population. Disease status (relapsed vs. refractory) and bone marrow involvement were factors significantly associated with complete response in univariate analysis, warranting further validation.
Lv et al. (Mon,) studied this question.