Regeneron's Ordspono: - EC Decision in 3L r/r FL & DLBCL

The European Comission has granted its Decision for Ordspono (odronextamab) to treat 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.

The approval is based on results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated durable response rates in adults with r/r FL or r/r DLBCL: 

• In r/r FL, results from ELM-2 (N=128) as assessed by an independent review committee (IRC) showed an objective response rate (ORR) of 80%, with 73% achieving a complete response (CR). Among complete responders, the median duration of response (DoR) was 25 months (95% confidence interval [CI]: 20 months to not estimable [NE]).
• In r/r DLBCL,
  • results from ELM-2 (N=127) 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 (95% CI: 10 months to NE).
  • results from ELM-1 (N=60) in patients who had progressed after CAR-T therapy, as assessed by an IRC showed 48% ORR, with 32% achieving a CR. Among responders (n=29), the median DoR was 15 months (95% CI: 3 months to NE).

Reference link: Regeneron press release