Regeneron Pharmaceuticals has secured European Commission (EC) approval for Ordspono (odronextamab) to treat relapsed or refractory (R/R) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL).
 
Ordspono, a bispecific antibody, targets lymphoma cells and links them to killer T cells.
This marks the first global regulatory approval for Ordspono in these indications.
 
“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 Santa 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 EC approval is based on data from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials. In R/R FL, the objective response rate (ORR) was 80% in ELM-2, with 73% achieving complete response. For R/R DLBCL, the ORR was 52% in CAR-T therapy-naive patients and 48% in those who had progressed after CAR-T therapy.
 
“Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. “Building upon this approval, we are excited about our OLYMPIA program, which includes multiple Phase 3 trials investigating Ordspono as a monotherapy and in various combinations, in earlier lines of therapy. We’re also excited to be advancing our broader pipeline of CD3 and other bispecific therapies, both to additional hematologic cancers such as myeloma, as well as to solid tumors.”
 
The approval of Ordspono represents a significant advancement in the treatment of R/R FL and DLBCL. It offers a new option for patients who have exhausted other treatment options and may improve outcomes for these challenging diseases. The approval also highlights the potential of bispecific antibodies as a promising therapeutic approach for various cancers.