ASH 2020 | A first-in-human trial of REGN5458 in R/R myeloma: updated Phase I data
Deepu Madduri, MD, Icahn School of Medicine at Mount Sinai, New York, NY, shares updated data from a first-in-human Phase I trial (NCT03761108) of REGN5458 in relapsed/refractory (R/R) multiple myeloma patients. REGN5458 is a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, thus allowing T-cell targeted killing of BCMA-expressing multiple myeloma cells. Trial results indicate an acceptable safety and tolerability profile for REGN5458, with the most common treatment-related adverse event being low-grade cytokine release syndrome (CRS). Efficacy results from the 49 heavily pretreated R/R multiple myeloma patients that took part in the dose escalation study demonstrated early, deep and durable responses, with a total overall response rate (ORR) of 39% and 42% of responders achieving a complete response. Importantly, 37% of responders maintained their response for 8 months or more. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Disclosures
Dr Deepu Madduri, MD, has received research support from Regeneron Pharmaceuticals, Inc., Amgen, Allogene, Celgene, Bristol Myers Squibb and Janssen; has done consultancy work with Bristol Myers Squibb, Celgene, GlaxoSmithKline, Kinevant, Janssen, Legend, Millennium/Takeda and Sanofi Genzyme; and has participated in scientific advisory boards with Bristol Myers Squibb, Celgene, GlaxoSmithKline, Kinevant, Janssen, Legend and Sanofi Genzyme.
