biostudies-literatureUnknown16(21-22)Zhu FImmunoGen<b>Aim:</b> The aim of this research was to evaluate the immunogenicity of mirvetuximab soravtansine (MIRV), an antibody-drug conjugate in patients with folate receptor alpha-positive ovarian cancer across four clinical studies.<b>Materials & methods:</b> An assay was developed and validated for the detection of antidrug antibodies (ADAs) against MIRV. A cell-based method was also developed and validated for the detection of neutralizing anti-MIRV antibodies (NAbs). Both ADAs and NAbs were assessed across four clinical studies in 734 patients.<b>Results:</b> Across studies, MIRV demonstrated low immunogenicity with 7.8% of patients with treatment-emergent ADAs, 7.2% with treatment-unaffected ADAs, and 0.5% with treatment-enhanced ADAs. MIRV trough concentrations were comparable in ADA-negaBioanalysis1101-1113https://www.ebi.ac.uk/biostudies/studies/S-EPMC11583603biostudies-literatureAssessment of mirvetuximab soravtansine immunogenicity in patients with folate receptor alpha-positive ovarian cancer.PMC11583603Tu YPZhu FSloss CWang YfalseAssessment of mirvetuximab soravtansine immunogenicity in patients with folate receptor alpha-positive ovarian cancer.<b>Aim:</b> The aim of this research was to evaluate the immunogenicity of mirvetuximab soravtansine (MIRV), an antibody-drug conjugate in patients with folate receptor alpha-positive ovarian cancer across four clinical studies.<b>Materials & methods:</b> An assay was developed and validated for the detection of antidrug antibodies (ADAs) against MIRV. A cell-based method was also developed and validated for the detection of neutralizing anti-MIRV antibodies (NAbs). Both ADAs and NAbs were assessed across four clinical studies in 734 patients.<b>Results:</b> Across studies, MIRV demonstrated low immunogenicity with 7.8% of patients with treatment-emergent ADAs, 7.2% with treatment-unaffected ADAs, and 0.5% with treatment-enhanced ADAs. MIRV trough concentrations were comparable in ADA-nega2024-01-01T00:00:00Z20242026-04-24T03:25:22.181Z2025-04-03T23:56:44.634ZS-EPMC115836033937805610.1080/17576180.2024.2407228