Vor Bio announced updated clinical data from its ongoing Phase 1/2 VBP101 study of patients with relapsed/refractory AML receiving trem-cel followed by Mylotarg™, presented at the American Society of Hematology (ASH) Annual Meeting on December 8, 2024. The data, with a cut-off of November 1, 2024, included 25 patients, 15 of whom received Mylotarg.
The results demonstrated durable engraftment, effective shielding from Mylotarg on-target toxicity, and a broadened therapeutic window for Mylotarg. Early evidence also suggested improved relapse-free survival compared to published high-risk AML comparators, indicating potential clinical benefits for patients.
Furthermore, Vor Bio received supportive feedback from the FDA in a Type C meeting regarding a proposed registrational clinical trial synopsis. The FDA agreed that trem-cel engrafts neutrophils and platelets, has a similar safety profile to unedited CD34+ grafts, and concurred with the proposed registrational trial design elements including study population, control arm, primary endpoint, stratification factors, and statistical design.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.