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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 (ORR) in evaluable patients at the 5.2 mg/kg starting dose – the selected dose for randomized portion (Part 2) of ongoing
About this update from Sutro Biopharma, Inc.
[{"type":"text","content":"- 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). \"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.\" REFRαME-O1 (Part 1) REFRαME-O1 (Part 1) evaluated luvelta in patients with PROC with low, medium, and high FRα expression levels. This includes patients with ≥25% Tumor Proportion Score (TPS), defined as at least 25% of tumor cells expressing FRα, at any staining intensity. In the dose-optimization (Part 1), patients were randomized 1:1 to a 5.2 mg/kg with prophylactic pegfilgrastim (G-CSF) for 2 cycles followed by 4.3 mg/kg for subsequent cycles (5.2 mg/kg group), or a 4.3 mg/kg dose of luvelta for all cycles (4.3 mg/kg group). We plan to present additional data at future medical meetings. Topline Results from Evaluable Patients (5.2 mg/kg group; N = 25): Achieved an objective response rate (ORR) of 32%, which includes one partial response that confirmed post data extraction1Disease control rate of 96%Approximately half of the patients treated were ineli...