Sutro Biopharma (STRO) announced the selected dose from the dose-optimization portion of REFRalphaME-O1, the registration-directed trial of luveltamab tazevibulin 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 FRalpha 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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