Shots:
- The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT
- Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all pts & its 2EPs of improved RFS & OS in pts with BRCAwt molecular profile; Data published in the Lancet Oncology & the Gynecologic Oncology
- Vigil is an immunotherapy platform that utilizes bi-shRNA for modifying pts’ tumors & maximizes GM-CSF expression to stimulate the immune system with the activation of key immune response cells incl. T-cells
Ref: Globenewswire | Image: Gradalis
Related News:- Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
