(RTTNews) - Sutro Biopharma Inc. (STRO) announced expanded data in a late-breaking oral presentation from the dose-optimization portion of the REFRaME-O1 trial with luveltamab tazevibulin (luvelta) in patients with platinum resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer. In the study, luvelta demonstrated encouraging antitumor activity in patients with late-stage ovarian cancer across all levels of Folate Receptor-a or FRa expression of 25% or greater, including an improved overall response rate (ORR), a low discontinuation rate, and a consistent safety profile across dose levels. Based on the findings, Sutro selected the optimized dose of luvelta: 5.2 mg/kg + G-CSF for two cycles then continued on 4.3 mg/kg.
At the selected optimized dose (5.2 mg/kg), luvelta achieved an ORR of 32%1 and a disease control rate (DCR) of 96% compared to an ORR of 13.8% and a DCR of 69% for the 4.3 mg/kg group.
The company noted that the demonstrated clinical activity in the 5.2 mg/kg group was consistent in patients across all levels of FRa expression of 25% or greater, with an ORR of 30.8% and a DCR of 100% for positive staining (PS) 2+ =75% (eligible for approved FRa-targeting ADC) and an ORR of 33.3%1 and DCR of 91.7%1 for PS2+ 75%.
According to the company, safety was consistent across dosing groups, with no new safety signals observed and neutropenia well-managed.
The majority of patients across both dose cohorts received prior bevacizumab.
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