CHMP Recommends Odronextamab for EU Approval to Treat Relapsed/Refractory Follicular and Diffuse Large B-cell Lymphomas

Regeneron Pharmaceuticals, Inc., headquartered in Tarrytown, N.Y., has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion recommending conditional marketing approval for odronextamab. This drug is intended for adults with relapsed or refractory (R/R) follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after undergoing at least two systemic therapies. The European Commission is expected to finalize the decision within the coming months.

Follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) are prevalent subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL, a slow-growing cancer, remains incurable and often relapses post-treatment. On the other hand, DLBCL is more aggressive, with a significant proportion of high-risk patients experiencing relapse or resistance to initial treatments. Annually, worldwide diagnoses of FL and DLBCL are approximately 120,000 and 163,000 cases, respectively. In Europe, these numbers are estimated to be around 15,000 FL cases and 31,000 DLBCL cases each year.

The CHMP's positive opinion is based on data from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which highlighted strong and enduring response rates alongside an acceptable safety profile for odronextamab in adults with R/R FL or DLBCL. Within a combined safety population, the most frequent severe adverse reactions included cytokine release syndrome, pneumonia, COVID-19, and fever.

Previously, the EMA has granted odronextamab Orphan Designation for both FL and DLBCL. Currently, odronextamab is still in the clinical development phase and has not yet received approval from any regulatory bodies.

Regeneron is actively exploring the potential of odronextamab both as a standalone treatment and in combination with other therapies for difficult-to-treat lymphomas. This includes studies from the ELM-1 and ELM-2 trials, the expansive Phase 3 OLYMPIA development program, as well as early-stage trials that aim to combine odronextamab with chemotherapy-free treatments.

Odronextamab is an investigational CD20xCD3 bispecific antibody designed to connect CD20 on cancer cells with CD3-expressing T cells, thereby facilitating localized T-cell activation and subsequent cancer cell destruction.

The ELM-1 trial is an ongoing, open-label, multicenter Phase 1 study assessing the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies who have previously undergone CD20-directed antibody therapy, including patients who have progressed post-CAR-T therapy.

The ELM-2 trial, an ongoing, open-label, multicenter Phase 2 study, is investigating odronextamab across five independent disease-specific cohorts, such as DLBCL, FL, mantle cell lymphoma, and marginal zone lymphoma. The primary endpoint is the objective response rate based on the Lugano Classification, with secondary endpoints including complete response, progression-free survival, overall survival, and duration of response.

Additionally, Regeneron is conducting investigations of odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and their PD-1 inhibitor cemiplimab for R/R aggressive B-NHL through the ATHENA-1 and CLIO-1 studies.

Regeneron Pharmaceuticals is a leading biotechnology firm that develops pioneering medicines for severe diseases. Founded by physician-scientists, the company has successfully translated scientific insight into numerous approved treatments and promising product candidates. The company's efforts span various medical conditions, including eye diseases, cancer, cardiovascular and metabolic disorders, and rare diseases.

Regeneron employs proprietary technologies such as VelociSuite® to expedite drug discovery and development, producing optimized fully human antibodies and new classes of bispecific antibodies. Their cutting-edge work includes utilizing data-driven insights from the Regeneron Genetics Center® to identify innovative targets and approaches to potentially treat or cure diseases.