PRESS RELEASE
For Immediate Release
GOG-3086 (REFRaME-01)
Sutro Biopharma Announces Selected Dose for Luvelta and Topline Results from Dose-Optimization Portion of REFRαME-O1 Trial in Platinum Resistant Ovarian Cancer
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).
“The topline results confirm luvelta’s favorable safety and efficacy profile at the starting dose of 5.2 mg/kg, further supporting our confidence that it can improve clinical outcomes compared to chemotherapy in our ongoing registrational trial,” said Anne Borgman, M.D., Sutro’s Chief Medical Officer. “Consistent response rates were observed in patients across all levels of FRα expression of 25% or greater, reconfirming luvelta’s potential to expand the benefit of a targeted treatment to 8 out of 10 PROC patients.”
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