Regeneron Pharmaceuticals has announced that its investigational CD20xCD3 bispecific antibody has been recommended by the European Medicine Agency’s (EMA) human medicines committee to treat certain lymphomas.
The Committee for Medicinal Products for Human Use (CHMP) has recommended odronextamab to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), following two or more lines of systemic therapy.
Recognised as the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL), FL, a slow-growing subtype, is estimated to be responsible for approximately 120,000 annual diagnoses globally , while DLBCL, an aggressive subtype, is responsible for 163,000.
The recommendation was based on results from the phase 1 ELM-1 and phase 2 ELM-2 trials, as part of the odronextamab clinical trial programme, which has been assessing the investigational drug in patients with CD20+B-cell malignancies following CD20-directed antibody therapy, including patients who had progressed after CAR-T therapy (ELM-1) and in adults living with DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL (ELM-2).
Odronextamab is designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer cell killing.
Results from both trials demonstrated robust and durable response rates in both R/R FL and R/R DLBCL, as well as an acceptable safety profile.
An analysis from ELM-1 among 44 efficacy-evaluable patients, of whom 73% were refractory to CAR T-cell therapy , showed a 48% overall response rate (ORR) and a 30% complete response (CR) rate.
Presented at the 2023 American Society of Hematology Annual Meeting, updated findings from ELM-2 showed an 80% ORR and 73% CR rate among 128 patients with R/R FL, while findings from the primary phase 2 analysis of ELM-2 showed a 52% ORR and 31% CR rate among 127 patients with DLBCL.
The recommendation comes after the EMA granted odronextamab Orphan Designation for FL and DLBCL and was previously accepted for priority review by the US Food and Drug Administration in 2023 to treat certain NHL patients.
Regeneron is currently investigating odronextamab as a monotherapy and in combination across earlier lines of therapy in hard-to-treat lymphomas, including the ELM-1 and ELM-2 studies, as well as the phase 3 OLYMPIA development programme.