Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of 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, including in the post-CAR-T setting.
Ordspono, which targets both CD20 and CD3, aims to bridge cancer cells expressing CD20 with CD3-expressing T cells, thereby activating local T-cells to induce cancer cell death.
This approval follows a setback earlier this year when the U.S. FDA declined to approve the drug in March, citing concerns related to clinical trial design rather than safety or efficacy issues. Regeneron based its EU and FDA submissions on data from the Phase I ELM-1 and pivotal Phase II ELM-2 trials. In the ELM-2 study, 128 patients with R/R FL exhibited an impressive objective response rate (ORR) of 80%, with 73% achieving a complete response (CR) and a median duration of response (DoR) of 25 months. For R/R DLBCL, CAR-T therapy-naive patients showed a 52% ORR and a 31% CR, with a median DoR of 18 months. Among those previously treated with CAR-T, the ORR was 48%, with 32% achieving CR and a median DoR of 15 months.
The FDA issued two Complete Response Letters (CRLs) in March, focusing on the patient enrollment status of the confirmatory OLYMPIA trial, emphasizing that full enrollment must be completed before reconsidering approval based solely on Phase I/II data. Regeneron plans to address these concerns and re-file in the near future.- Flcube.com
