Characterization of folate receptor alpha (FRα) expression in archival tumor and biopsy samples from relapsed epithelial ovarian cancer patients: A phase I expansion study of the FRα-targeting antibody-drug conjugate mirvetuximab soravtansine

摘要: Abstract Purpose To characterize folate receptor alpha (FRα) expression in archival and fresh biopsy tumor samples from relapsed ovarian cancer patients. Methods Patients with tumors amenable to were eligible enroll. Eligibility included a minimum requirement of FRα positivity (≥25% cells ≥2+ staining intensity). received mirvetuximab soravtansine at 6mg/kg once every 3weeks. Core needle biopsies collected before after treatment levels assessed by immunohistochemistry. Descriptive statistics used summarize the association between response. Results Twenty-seven heavily pre-treated patients enrolled. Six individuals (22%) did not have evaluable pre-treatment due insufficient cells. The concordance tissues was 71%, no major shifts seen matched pre- post-treatment samples. Adverse events generally mild (≤grade 2) keratopathy (48%), fatigue (44%), diarrhea, blurred vision (each 37%) being most common treatment-related toxicities. confirmed objective response rate (ORR) 22%, including two complete responses four partial responses. Superior efficacy measures observed subset highest (ORR, 31%; progression-free survival, 5.4months). Conclusion Concordance versus suggests that tissue can reliably identify receptor-positive is appropriate for patient selection clinical trials. Regardless source analyzed, higher associated greater antitumor activity.