Sutro Biopharma Announces Selected Dose for Luvelta and Topline Results from Dose-Optimization Portion of REFRαME-O1 Trial in Platinum Resistant Ovarian Cancer (GlobeNewswire) - Dec 10, 2024 - P2/3 | N=600 | REFRaME-O1 (NCT05870748) | Sponsor: Sutro Biopharma, Inc. | "32% objective response rate (ORR) in evaluable patients at the 5.2 mg/kg starting dose – the selected dose for randomized portion (Part 2) of ongoing registrational REFRαME-O1 trial; These data confirm luvelta’s robust response rate in patients with late-stage ovarian cancer expressing a broad range of folate receptor alpha (FRα); Neutropenia well-managed; no new safety findings; Luvelta is positioned for an Accelerated Approval application in mid-2027."
FDA filing • P2/3 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor
|