Regeneron’s Odronextamab Receives Positive CHMP Opinion for Relapsed/Refractory Lymphoma
Introduction
On Friday, Regeneron Pharmaceuticals Inc announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional approval of odronextamab for relapsed/refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. This approval marks a significant step forward in the treatment of patients with relapsed/refractory lymphoma, and here’s everything you need to know about it.
Follicular Lymphoma and Diffuse Large B-cell Lymphoma: The Two Most Common Subtypes of B-cell Non-Hodgkin Lymphoma (B-NHL)
Relapsed/refractory (R/R) follicular lymphoma (FL) refers to cases where FL comes back after initial treatment (relapsed) or doesn’t respond to treatment (refractory). Similarly, R/R diffuse large B-cell lymphoma (DLBCL) occurs when DLBCL relapses or doesn’t respond to therapy. FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). It is estimated that approximately 120,000 FL cases and 163,000 DLBCL cases are diagnosed annually worldwide. In Europe, it is estimated that approximately 15,000 FL cases and 31,000 DLBCL cases are diagnosed each year.
The Positive CHMP Opinion is Supported by Results from Phase 1 ELM-1 and Phase 2 ELM-2 Trials
The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab. Odronextamab is a humanized, bispecific antibody that targets CD20 and CD3, two proteins that are expressed on the surface of B cells and T cells, respectively. The binding of odronextamab to CD20 on the surface of B cells leads to the recruitment of CD3-positive T cells, which then directly attack and kill the malignant B cells. This mechanism of action is different from that of traditional monoclonal antibodies, such as rituximab, which only target CD20 and do not engage T cells.
Regeneron Continues to Evaluate the Use of Odronextamab for Challenging-to-Treat Lymphomas
Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs, and early-stage trials with chemotherapy-free combinations. For instance, Regeneron is investigating odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and Regeneron’s cemiplimab for R/R aggressive B-NHL through the ATHENA-1 and CLIO-1 studies, respectively.
Conclusion
The positive CHMP opinion regarding odronextamab for relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma is a significant development in the treatment of lymphoma. As Regeneron continues to evaluate the use of odronextamab in earlier lines of therapy and additional B-NHLs, we can only hope for similar positive results, which will improve the prognosis for those suffering from these challenging-to-treat types of lymphoma.
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