Therapeutic outcomes of glofitamab-based regimens in Chinese patients with Relapsed/Refractory B-cell lymphoma: A single-center retrospective real-world study

Abstract Background: Glofitamab has demonstrated promising efficacy in relapsed/refractory (R/R) Diffuse large B-cell lymphoma (DLBCL) in global trials, with durable responses observed in heavily pretreated patients. Given the limited studies on glofitamab in the real-world evidence in Chinese populations, we systematically analyzed the therapeutic outcomes of glofitamab, either as monotherapy or in combination with chemotherapy, in Chinese patients with R/R B cell lymphoma. Methods:This single-center retrospective study enrolled patients with R/R B cell lymphoma who received glofitamab-based therapy (either as monotherapy or in combination regimens) at the First Affiliated Hospital of China Medical University. Comprehensive clinical data were systematically collected, including baseline characteristics, treatment details, efficacy outcomes, treatment-related adverse events (AEs). Results: This study enrolled 20 adult patients (age ≥18 years) with relapsed/refractory (R/R) B-cell lymphoma who received glofitamab-based therapy (monotherapy or combination regimens). The cohort comprised 14 males and 6 females (male: female= 2.3:1), with a median age of 68 years (range: 42–75; mean: 63). Histological subtypes included DLBCL (n=11; non-GCB subtype: 8; double-expression: 3), high-grade B-cell lymphoma (n=3), Primary Central Nervous System Lymphoma (PCNSL, n=2), Burkitt lymphoma(n=2), follicular lymphoma (FL, n=1), DLBCL transformed from follicular lymphoma (n=1). TP53 mutations were detected in 4 patients. Prior treatment lines were: 1 line (n=9), 2 lines (n=7), and ≥3 lines (n=4), including one CAR-T therapy failure patient. Treatment regimens consisted of glofitamab monotherapy (n=10), glofitamab plus chemotherapy (n=8), and glofitamab plus polatuzumab vedotin (n=2). The median treatment duration was 4 cycles, with 7 months' median follow-up. In 14 efficacy-evaluable patients, the overall response rate (ORR) was 92.8%, with complete response (CR) in 5 cases (35.7%), partial response (PR) in 8 (57.1%), and stable disease (SD) in 1(7.1%). Among these patients, one who failed prior CAR-T therapy achieved PR with glofitamab plus polatuzumab vedotin combination therapy. Additionally, two other patients received glofitamab as bridging therapy before CAR-T, attaining PR with favorable safety profiles. Safety analysis in all 20 patients revealed grade 1 cytokine release syndrome (CRS) in 7 patients, grade 3 CRS in 1, grade 3–4 lymphopenia in 12, SARS-CoV-2 infection in 2, Pneumocystis pneumonia (PCP) in 1, community-acquired pneumonia (CAP) in 1, and biliary tract infection in 1. Conclusion: Glofitamab-based therapy shows superior efficacy and a manageable safety profile in Chinese R/R B-cell lymphoma patients, potentially establishing it as a preferred treatment option for this population.