REFRaME-O1/ENGOT-OV79/GOG-3086: A phase II/III, open-label study evaluating the efficacy and safety of luveltamab tazevibulin versus investigator's choice of chemotherapy in women with relapsed platinum-resistant epithelial ovarian cancer expressing folate receptor alpha (SGO 2024) - Feb 4, 2024 - Abstract #2157; Pres time: Mar 18, 2024; 11:45 AM - 12:45 PM; "Part 1 consists of a dose-optimization stage and will randomize ~50 subjects 1:1 to the treatment of luvelta at 4.3 mg/kg Q3W or luvelta 5.2 mg/kg Q3W + prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg Q3W. Key inclusion criteria are progressive PROC, up to 3 prior regimens, tumor proportion score by immunohistochemistry of ≥25% for FolRα expression, and measurable radiologic disease. Key exclusion criteria are primary platinum refractory disease and prior treatment with a FolRα targeting antibody drug conjugate (ADC) or ADC containing a tubulin inhibitor."
Clinical • P2/3 data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • PROC
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R. Wendel Naumann; MD; Levine Cancer; Atrium Health; Charlotte; NC; GYN Oncology; Jung-Yun Lee; MD; PhD; Thomas J. Herzog; MD; Robert Coleman; MD; Isabelle Ray Coquard; MD; PhD; Rowan E. Miller; MD; PhD; Lin Lu; PhD; Craig Berman; MD; Muaz Sadeia; PharmD; Ana Oaknin; MD; PhD
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