Efficacy and safety of luveltamab tazevibulin vs investigator's choice of chemotherapy in patients with recurrent platinum-resistant ovarian cancer (PROC) expressing folate receptor alpha (FRα): The REFRaME-01 (GOG-3086, ENGOT-79ov, and APGOT-OV9) phase 2/3 study. (ASCO 2024) - Apr 25, 2024 - Abstract #TPS5637; Pres time: Jun 3, 2024; 09:00 AM - 12:00 PM; Location: Hall A; Poster Bd #: 500a; P2/3 | "Eligible pts are adults (≥18 years) with relapsed PROC, 1–3 prior lines of therapy (which must include bevacizumab), measurable disease, Eastern Cooperative Oncology Group performance status ≤1, and TPS for FRα expression ≥25% using Ventana validated IHC assay...In part 2 (phase 3) ~550 pts will be enrolled and randomized 1:1 to the optimal luvelta dosing regimen or IC chemotherapy (gemcitabine, paclitaxel, pegylated liposomal doxorubicin, or topotecan). Primary endpoints are PFS and ORR, with response evaluated per RECIST v1.1. Secondary endpoints include overall survival, DOR, safety, and quality of life."
Clinical • P2/3 data • Anemia • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • PROC
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Ana Oaknin; Jung-Yun Lee; David Cibula; Yeh Chen Lee; Russell J. Schilder; Annika Auranen; Bo Gao; David Shao Peng Tan; Amit M. Oza; Rowan Miller; Vanda Salutari; Giulia Tasca; David M. O'Malley; Bradley J. Monk; Bhavana Pothuri; Lin Lu; Craig Berman; Anne Borgman; R. Wendel Naumann
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