Press release
Ordspono™ (odronextamab) Approved in the European Union for the Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma
Approval of Ordspono is based on data demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma and diffuse large B-cell
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Approval of Ordspono is based on data demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, including in the post-CAR-T setting Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission TARRYTOWN, N.Y., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. This marks the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell. “The EC approval of Ordspono is a meaningful advancement for EU patients and their physicians as a new option to treat both indolent and aggressive lymphomas,” said Stefano Luminari, M.D., Professor of Oncology at the University of Modena and Reggio Emilia, hematologist at the Hematology Unit of Arcispedale Sant Maria Nuova in Reggio Emilia, and a trial investigator. “In clinical trials, Ordspono demonstrated remarkable complete response rates in follicular lymphoma, as well as compelling efficacy results in diffuse large B-cell lymphoma, including in the post-CAR-T setting. Physicians, especially in the community setting, will have an off-the-shelf option that can be administered out-patient – offering the chance for complete remission.” The approval is based on results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL: In R/R FL, results from ELM-2 (N=128) as assessed by an independent review committee (IRC) showed an objective response rate (ORR) of 80%, with 73% achieving a complete response (CR). Among complete responders, the median duration of response (DoR) was 25 months (95% confidence interval [CI]: 20 months to not estimable [NE]).In R/R DLBCL, results from ELM-2 (N=127) in patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR. Among complete responders the median DoR was 18...