Regeneron’s Ordspono (odronextamab) has been approved by the European Commission (EC) to treat two common subtypes of non-Hodgkin lymphoma.
The CD20xCD3 bispecific antibody has been specifically authorised to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), following at least two lines of systemic therapy.
The EC’s decision marks the first regulatory approval of Ordspono globally for these patients and follows a recent recommendation from the European Medicines Agency’s human medicines committee.
Approximately 15,000 FL cases and 31,000 DLBCL cases are diagnosed in Europe every year.
Regeneron’s Ordspono is designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
The approval of the drug was supported by positive results from the phase 1 ELM-1 and phase 2 ELM-2 trial, which Regeneron said demonstrated “robust and durable” response rates in adults with R/R FL or R/R DLBCL.
ELM-2 demonstrated an objective response rate (ORR) of 80% in R/R FL patients receiving Ordspono, with 73% achieving a complete response (CR).
In R/R DLBCL, results from ELM-2 showed an ORR of 52% and CR rate of 31% in patients who were CAR-T therapy naive. For those who had progressed after CAR-T therapy, an ORR of 48% was seen in ELM-1, with 32% achieving a CR.
“In clinical trials, Ordspono demonstrated remarkable CR rates in FL, as well as compelling efficacy results in DLBCL, including in the post-CAR-T setting,” said trial investigator Stefano Luminari, University of Modena and Reggio Emilia, and Arcispedale Santa Maria Nuova.
“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 added.
The approval comes five months after the US Food and Drug Administration declined to approve odronextamab for these indications.
Regeneron outlined in a statement at the time that the only “approvability issue” was related to the enrolment status of the drug’s confirmatory trials.
George Yancopoulos, board co-chair, president and chief scientific officer of Regeneron, said in the company’s latest statement: “Building upon [the EC’s] approval, we are excited about our OLYMPIA programme, which includes multiple phase 3 trials investigating Ordspono as a monotherapy and in various combinations, in earlier lines of therapy.”