Tuesday, July 16, 2024

New Hope for Lymphoma Treatment: Positive EMA Opinion for Odronextamab

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Lymphoma treatment with odronextamab has received a positive opinion for conditional marketing authorization from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), as announced by Regeneron Pharmaceuticals. This recommendation aims to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The final decision by the European Commission is expected in the coming months.

Follicular lymphoma and diffuse large B-cell lymphoma are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing but incurable disease, with most patients experiencing relapse after initial treatment. DLBCL, on the other hand, is aggressive, with up to 50% of high-risk patients facing disease progression after first-line treatment. Globally, approximately 120,000 FL cases and 163,000 DLBCL cases are diagnosed annually, with about 15,000 FL cases and 31,000 DLBCL cases diagnosed each year in Europe.

The CHMP’s positive opinion is backed by data from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust and durable response rates along with an acceptable safety profile for odronextamab in adults with R/R FL or R/R DLBCL. In the pooled safety population, the most common serious adverse reactions included cytokine release syndrome, pneumonia, COVID-19, and pyrexia.

Odronextamab Granted Orphan Designation by EMA and Shows Promise in Lymphoma Trials

Odronextamab had previously been granted Orphan Designation by the EMA for both FL and DLBCL. Although currently under clinical development and not yet approved by any regulatory authority, Regeneron is actively evaluating odronextamab both as a monotherapy and in combination therapies across earlier lines of treatment for challenging lymphomas. This includes the Phase 3 OLYMPIA development program, one of the largest clinical programs in lymphoma, as well as early-stage trials with chemotherapy-free combinations.

Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells, facilitating local T-cell activation and cancer-cell killing. The ELM-1 trial is an ongoing, open-label, multicenter Phase 1 study investigating the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies who have previously been treated with CD20-directed antibody therapy, including those who have progressed after CAR-T therapy.

The ELM-2 trial is an ongoing, open-label, multicenter Phase 2 study investigating odronextamab across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma, and other subtypes of B-NHL. The primary endpoint is the objective response rate according to the Lugano Classification as assessed by an independent review committee. Secondary endpoints include complete response, progression-free survival, overall survival, and duration of response.

Lymphoma

Regeneron Expands Lymphoma Research with Innovative Bispecific Antibody and PD-1 Inhibitor Studies

In addition to the Phase 3 OLYMPIA development program, Regeneron is investigating odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and Regeneron’s PD-1 inhibitor cemiplimab for R/R aggressive B-NHL through the ATHENA-1 and CLIO-1 studies, respectively.

Regeneron is dedicated to applying over three decades of biological expertise and its proprietary VelociSuite® technologies to develop treatments for diverse blood cancers and rare blood disorders. The company’s research in blood cancers focuses on bispecific antibodies, investigated both as monotherapies and in combination with other emerging therapeutic modalities. This approach provides unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.

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In collaboration with other research entities, Regeneron is also exploring potential treatments for rare blood disorders. This includes work in antibody medicine, gene editing, gene-knockout technologies, and investigational RNA approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.

 

Resource: Regeneron Pharmaceuticals, June 28, 2024

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