Core Insights - Sutro Biopharma has initiated the REFRαME-P1 study for luveltamab tazevibulin (luvelta) targeting pediatric patients with CBFA2T3::GLIS2 acute myeloid leukemia (AML) [1][4] - The trial aims to address a significant unmet need in treating a rare and aggressive form of leukemia in infants and toddlers [2][3] - Luvelta has shown promising results in previous compassionate use cases, with a 42% complete remission rate in pediatric patients [2][3] Company Overview - Sutro Biopharma is a clinical-stage oncology company focused on developing site-specific antibody-drug conjugates (ADCs) [1][8] - The company utilizes its proprietary XpressCF® platform for the development of its therapeutics, including luvelta [6][8] - Sutro has multiple clinical-stage candidates and is engaged in various trials for different cancer types, including ovarian and endometrial cancers [6][8] Clinical Development - The REFRαME-P1 study is a global registration-enabling trial for luvelta in children under 12 years with CBF/GLIS AML [4] - The study is expected to have most sites operational by the end of 2024 [4] - Luvelta has received Fast Track designation from the FDA for ovarian cancer and Orphan and Rare Pediatric Disease designations for CBF/GLIS pediatric AML [7]
Sutro Biopharma Announces Initiation of the Registration-enabling REFRαME-P1 Trial with Luvelta for Pediatric Patients with CBF/GLIS AML