CHMP Recommends Regeneron's Odronextamab for Certain Lymphomas

Regeneron Pharmaceuticals has revealed that its experimental CD20xCD3 bispecific antibody has received a recommendation from the European Medicine Agency’s (EMA) human medicines committee for treating specific types of lymphomas.

The Committee for Medicinal Products for Human Use (CHMP) has advocated for the use of odronextamab in adults with either relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after they have undergone two or more lines of systemic treatment.

FL and DLBCL are recognized as the most prevalent subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL, known for its slow progression, accounts for an estimated 120,000 new cases each year globally, whereas DLBCL, an aggressive form, is responsible for 163,000 annual cases.

The endorsement is grounded on findings from the phase 1 ELM-1 and phase 2 ELM-2 clinical trials, which are part of the broader odronextamab clinical research initiative. This program has been evaluating the performance of the investigational drug in patients with CD20+B-cell malignancies who have previously received CD20-directed antibody therapy, including those who failed to respond after CAR-T therapy (ELM-1). The ELM-2 trial included adults diagnosed with various subtypes of B-NHL such as DLBCL, FL, mantle cell lymphoma, and marginal zone lymphoma.

Odronextamab is engineered to connect CD20 on cancer cells with CD3-expressing T cells, thereby promoting local T-cell activation and subsequent destruction of the cancer cells.

Data from these trials indicated strong and lasting response rates in both R/R FL and R/R DLBCL along with a tolerable safety profile. Specifically, an evaluation from the ELM-1 trial involving 44 patients, 73% of whom were resistant to CAR T-cell therapy, exhibited a 48% overall response rate (ORR) and a 30% complete response (CR) rate. At the 2023 American Society of Hematology Annual Meeting, updated results from the ELM-2 trial were presented, showing an 80% ORR and 73% CR rate among 128 patients with R/R FL. Additionally, in the primary phase 2 analysis of ELM-2, 127 patients with DLBCL exhibited a 52% ORR and a 31% CR rate.

This recommendation follows the EMA's previous decision to grant odronextamab Orphan Designation for FL and DLBCL. The drug was also accepted for priority review by the US Food and Drug Administration in 2023 for the treatment of certain NHL patients.

Regeneron continues to explore the potential of odronextamab as both a standalone treatment and in combination with other therapies across various stages of treatment for challenging lymphomas. This ongoing research includes the ELM-1 and ELM-2 studies as well as the phase 3 OLYMPIA development program.