Sutro Biopharma Announces Selected Dose For Luvelta And Topline Results From Dose-Optimization Portion Of REFRαME-O1 Trial In Platinum Resistant Ovarian Cancer; 32% Objective Response Rate 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
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 -
SOUTH SAN FRANCISCO, Calif., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ:STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced the selected dose from the dose-optimization portion (Part 1) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), following a meeting with the U.S. Food and Drug Administration (FDA).