Phase 3, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared with Rituximab Plus Gemcitabine and Oxaliplatin in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

作者：Muhıt Özcan, Won Seog Kim, Huilai Zhang, Maria Bouzani, Zsolt Nagy, Hun Chuah, Gilles Salles, Edwin E. Jeng, Jiangeng Huang, Mariana Sacchi, Yajian Jiang, Adrian Minson · 发表于：Blood · 年份：2024 · DOI：10.1182/blood-2024-198700 · 被引用次数：4 · 研究领域：Lymphoma Diagnosis and Treatment、Chronic Lymphocytic Leukemia Research、Monoclonal and Polyclonal Antibodies Research

Introduction: Outcomes for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) are poor, especially for those ineligible for autologous stem cell transplantation. Despite the high response rate with chimeric antigen receptor T-cell therapy (CAR T), not all patients are able to receive CAR T due to fitness/comorbidities, geographical access, manufacturing constraints, or reimbursement. Epcoritamab is a subcutaneous (SC) CD3xCD20 bispecific antibody approved in various regions including the US, Europe, and Japan for patients with R/R DLBCL. Lenalidomide is an immunomodulatory agent that has demonstrated single-agent activity and is approved in combination with other agents for patients with DLBCL. Given the converging effects on T-cell activation and tumor suppression, it is hypothesized that combination of epcoritamab and lenalidomide (E-Len) may further enhance tumor killing. In the ongoing phase 1b/2 EPCORE NHL-5 study (NCT05283720), E-Len demonstrated high response rates (overall response rate, 18/24 [75.0%]; complete response rate, 14/24 [58.3%]) in patients with R/R DLBCL and a manageable safety profile (Avivi ASH 2023, abstract 438). Here, we describe the phase 3, open-label, randomized, global study (NCT06508658) comparing E-Len to rituximab plus gemcitabine and oxaliplatin (R-GemOx). We evaluated the efficacy and safety of E-Len versus R-GemOx in patients with R/R DLBCL. Methods: Eligible patients (age ≥18 years) must have histologically confi...