Sutro Biopharma, Inc. announced that the randomized portion (Part 2) of REFRaME-O1, the registration-directed trial of luvelta (luvelta) in platinum-resistant ovarian cancer (PROC), is now open for enrollment, and the planned 50 patients in Part 1 of the trial have been enrolled. Luvelta is a novel Folate Receptor-a (FRa) targeting ADC with the potential to benefit 8 out of 10 PROC patients, including addressing high unmet medical need in patients with low-medium FRa expression. REFRaME-O1 is a global registration-directed study evaluating the efficacy and safety of luvelta versus chemotherapy in women with PROC with FRa expression =25% Tumor Proportion Score (TPS), defined as at least 25% or greater of tumor expressing FRa, at any intensity (1+,2+,3+).

In Part 2, approximately 500 patients will be enrolled and randomized 1:1 to the selected luvelta dose or investigators? choice of chemotherapy. The trial includes a planned interim analysis to support a potential application for accelerated approval.