The European Commission granted approval to Regeneron’s bispecific antibody, Ordspono, on Monday, marking its first regulatory success worldwide. Ordspono is now authorized for treating relapsed or refractory follicular lymphoma and diffuse large B cell lymphoma in patients who have undergone at least two prior lines of systemic therapy.
This approval is a significant milestone for Regeneron’s bispecific antibody platform. Stefano Luminari, professor of oncology at the University of Modena and Reggio Emilia, hailed Ordspono’s approval as a “meaningful advancement” for patients in the EU, providing a new and effective option for both indolent and aggressive lymphomas.
The European Commission's decision was based on data from the Phase I ELM-1 and pivotal Phase II ELM-2 trials, which demonstrated high and durable response rates in relapsed or refractory (R/R) follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL). In the ELM-2 study, R/R FL patients had an 80% objective response rate (ORR) and a 73% complete response (CR) rate. For those achieving CR, the median duration was 25 months. In CAR T-naïve R/R DLBCL patients, the ORR was 48% with a 32% CR rate. In ELM-1, R/R DLBCL patients who had progressed after CAR T therapy had a 48% ORR and 32% CR rate.
Ordspono, designed to bind the CD20 antigen on cancer cells and CD3 protein on T-cells, brings these elements closer together, thereby enhancing the body’s anti-cancer response. However, over half of the treated patients experienced cytokine release syndrome, which can be severe or life-threatening, and the bispecific antibody may also lead to serious or fatal infections. Other common side effects include pyrexia, anemia, and thrombocytopenia.
The FDA had rejected Regeneron’s application for Ordspono in March 2024 due to issues with the enrollment status of confirmatory trials but did not raise concerns regarding the drug’s safety, efficacy, trial design, labeling, or manufacturing.
Regeneron continues to advance Ordspono through a broad late-stage development program, including studies in earlier treatment settings and other B cell cancers.