A new global, multicenter study is enrolling patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) to evaluate the efficacy and safety of epcoritamab plus standard chemotherapy. Researchers presented their plans for the study, called EPCORE DLBCL-2, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
Standard treatment for DLBCL currently consists of R-CHOP. That regimen is associated with a five-year progression-free survival (PFS) of:
- 0% for patients with an International Prognostic Index (IPI) score of 2
- 4% for those with an IPI of 3
- 8% for patients with an IPI of 4–5
Epcoritamab is a monoclonal antibody that is administered subcutaneously and has been shown to kill malignant CD20-positive B cells. Previous investigations of epcoritamab have found that patients with aggressive relapsed or refractory large B-cell lymphoma tolerated the medication well and had an overall response rate (ORR) of 63%, as well as a complete response rate of 39%.
An ongoing phase I/II study is examining the drug’s effectiveness in high-risk (IPI 3–5) patients with newly diagnosed DLBCL. Thus far, results have shown that epcoritamab is effective and safe in that population. ORR has been 100%, with complete metabolic response (CMR) of 77%. Although about half of the patients have experienced cytokine release syndrome (CRS), most cases were low grade and did not require dose discontinuation.
Laurie Sehn, MD, of the BC Cancer Centre for Lymphoid Cancer and University of British Columbia in Vancouver, Canada, and colleagues believe these data support additional investigations of epcoritamab’s effectiveness in DLBCL. They are launching a phase III study to examine efficacy and safety of epcoritamab plus R-CHOP in about 900 adults newly diagnosed with one of several CD20-positive subtypes of DLBCL. Subjects must also have an IPI score of 2 or higher, an ECOG Performance Status score of 0–2, and one or more measurable disease sites. Patients will be randomized 2:1 to either six cycles of R-CHOP followed by two cycles of epcoritamab or six cycles of R-CHOP followed by two cycles of rituximab.
Analyses will focus on PFS, event-free survival, CMR, overall survival, and measureable residual disease negativity. The researchers also will track the incidence and severity of adverse events, including CRS, immune cell–associated neurotoxicity syndrome (also known as ICANS), and clinical tumor lysis syndrome.
Sehn LH, Chamuleau M, Lenz G, et al. Phase 3 trial of subcutaneous epcoritamab + R-CHOP versus R-CHOP in patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL): EPCORE DLBCL-2. Abstract #TPS7592. Presented at the 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, Illinois.