Regeneron announces EC approved Ordspono for adults

Regeneron Pharmaceuticals announced that the European Commission, EC, has approved Ordspono to treat adult patients with relapsed or refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, DLBCL, after two or more lines of systemic therapy. This marks the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell. The approval is based on results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL: In R/R FL, results from ELM-2 as assessed by an independent review committee showed an objective response rate of 80%, with 73% achieving a complete response. Among complete responders, the median duration of response was 25 months. In R/R DLBCL, results from ELM-2 in patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR. Among complete responders the median DoR was 18 months. results from ELM-1 in patients who had progressed after CAR-T therapy, as assessed by an IRC showed 48% ORR, with 32% achieving a CR. Among responders, the median DoR was 15 months. The most common adverse reactions were cytokine release syndrome, neutropenia, pyrexia, anemia, thrombocytopenia, diarrhea and COVID-19. The most common serious adverse reactions were CRS, pneumonia, COVID-19 and pyrexia. Ordspono can cause serious or fatal infections, and CRS, which may be serious or life-threatening.