With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
The European Commission on Monday signed off on Regeneron’s odronextamab, which will now be marketed as Ordspono, for the treatment of relapsed or refractory follicular lymphoma and diffuse large B cell lymphoma.
The EC’s green light marks the first approval of Ordspono worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform. The treatment is indicated for patients who had undergone at least two prior lines of systemic therapy.
Stefano Luminari, professor of oncology at the University of Modena and Reggio Emilia, in a statement called Ordspono’s approval “a meaningful advancement” for patients in the European Union, who will now have a new and effective treatment option for indolent and aggressive lymphomas.
“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,” Luminari said.
The EC’s decision was backed by data from the Phase I ELM-1 and pivotal Phase II ELM-2 studies, which showed that Ordspono treatment resulted in high and durable response rates in relapsed or refractory (R/R) follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL).
R/R FL patients in ELM-2 hit an objective response rate (ORR) of 80% following Ordspono treatment, with 73% showing complete response (CR)—the complete disappearance of all signs of the malignancy. In patients with complete response, median duration was 25 months. Response rates were lower for CAR T-naïve R/R DLBCL patients, in whom ORR was 48% and CR was 32%.
In ELM-1, R/R DLBCL patients who had progressed following CAR T therapy achieved a 48% ORR following Ordspono treatment, including 32% complete responders.
In terms of safety, the studies found that more than half of treated patients developed cytokine release syndrome, which in some cases can be serious or life-threatening. The bispecific antibody can also lead to “serious or fatal infections,” according to the pharma. Other common adverse events included pyrexia, anemia and thrombocytopenia.
Designed to connect the CD20 antigen on cancer cells and CD3 protein on T-cells, Ordspono is a bispecific antibody that works by bringing the body’s cancer-killing agents closer to their targets. Ordspono also activates the local T cell activity, in turn boosting the patients’ anti-cancer response.
In March 2024, the FDA rejected Regeneron’s application for Ordspono—also for R/R FL and R/R DLBCL—citing issues “related to the enrollment status of the confirmatory trials,” the pharma said at the time. The FDA did not flag problems with Ordspono’s safety or efficacy data, trial design, labelling or manufacturing.
In addition to ELM-1 and ELM-2, Regeneron is also running a broad late-stage development program for Ordspono, including studies that evaluate the bispecific antibody in earlier treatment settings and in other B cell cancers.
