Safety Findings Appear Encouraging for REGN5458 in Relapsed/Refractory Myeloma
Deepu Madduri, MD, discusses the safety findings from a first-in-human phase 1 study of REGN5458, a BCMA x CD3 bispecific monoclonal antibody, as treatment of patients with relapsed/refractory multiple myeloma.
Deepu Madduri, MD, assistant professor of medicine, hematology and medical oncology and assistant professor of urology at Mount Sinai, discusses the safety findings from a first-in-human phase 1 study (NCT03761108) of REGN5458, a BCMA x CD3 bispecific monoclonal antibody, as treatment of patients with relapsed/refractory multiple myeloma.
Cytokine release syndrome (CRS) and cytopenias are a big concern with bispecifics, says Madduri. Most grade 3 or higher toxicities observed in this trial were hematological, as expected, but the infection rate of grade 3 or higher was only 18%. The median time to onset of CRS was about 18 hours, but this event only occurred in 19 of the 49 patients. All cases of CRS were grade 1/2, and no grade 3 or higher CRS were observed.
According to Madduri, there was no relationship observed between the dose and CRS, nor CRS and response.
Age, Disease Burden Are Factors in Early Use of Selinexor in Multiple Myeloma
April 22nd 2024During a Case-Based Roundtable® event, Jonathan L. Kaufman, MD, discussed treatment approaches and the tolerability of a selinexor-containing regimen in a patient with relapsed/refractory multiple myeloma in the first article of a 2-part series.
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