Regeneron Highlights Its First Phase 2 Data To Build Case In CD20xC3 Bispecific Space

  • Regeneron Pharmaceuticals Inc REGN announced updated data from a Phase 1 and Phase 2 trial (ELM-1 and ELM-2) evaluating investigational odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). 
  • These included first data from a Phase 2 cohort of CAR-T naïve patients and updated data from a dose expansion cohort of a Phase 1 trial in patients who had progressed on CAR-T therapy.
  • In the first look at the Phase 2 portion, Regeneron said the objective response rate was 49% for 130 patients with diffuse large B-cell lymphoma. The complete response was 31%.
  • Investigators reported that the median duration of complete response was 18 months. 
  • In the patients who’d previously received CAR-T therapy, the overall response rate was 48% and CR 32%.
  • The median duration of the complete response has not been reached.
  • Patients were treated with a step-up regimen of odronextamab in the first cycle to help mitigate the risk of cytokine release syndrome (CRS) before receiving the full dose of 160 mg.
  • Treatment-related adverse events led 10% of 140 patients to discontinue, with more than 50% of patients reporting some level of cytokine release syndrome. There were no Grade 4 or 5 cases.
  • Price Action: REGN shares closed at $750.06 on Friday.
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