Repligen announces data for odronextamab in R/R FL from Phase 2 trial

Regeneron Pharmaceuticals announced positive data for odronextamab in patients with relapsed/refractory follicular lymphoma from a pivotal Phase 2 trial. These data – which include updated efficacy, safety and patient-reported outcomes – were presented at the 65th American Society of Hematology Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. As shared at ASH, longer-term data from the Phase 2 odronextamab trial continued to confirm high rates of durable responses in patients with R/R FL. As presented during an oral session at ASH, patients with R/R FL treated with odronextamab in the ELM-2 trial completed three validated questionnaires aimed at measuring health-related quality of life, functioning and symptoms. Pre-specified analyses were conducted across six scales. Overall, patients reported generally good HRQoL, functioning and low symptom burden at baseline as assessed across several scales. Key findings through Week 50 showed: Overall maintenance of moderate to high levels of functioning and HRQoL without detriments to patient-reported symptoms based on an analysis of changes in PRO scores from baseline over time, as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire scores. Median time to definitive deterioration in physical function and lymphoma-specific symptoms was not reached. In an individual patient-level analysis, more patients reported maintenance or clinically meaningful improvement in physical functioning and lymphoma-specific symptoms than deterioration at each assessment. Odronextamab is currently under regulatory review for the treatment of R/R FL and diffuse large B-cell lymphoma by the U.S. Food and Drug Administration, with a target action date of March 31, 2024, as well as by the European Medicines Agency (EMA). In the U.S., odronextamab has been granted Fast Track Designation by the FDA. In the European Union, odronextamab has been granted Orphan Drug Designation by the EMA. The potential use of odronextamab in R/R FL and R/R DLBCL is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.