RMAT Designation Granted by the FDA for Gemogenovatucel-T in Advanced Ovarian Cancer

By: JNCCN 360 Staff
Posted: Wednesday, February 12, 2025

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to the investigational cellular immunotherapy gemogenovatucel-T (Vigil) for use in the treatment of advanced ovarian cancer. RMAT designation is reserved for advanced cellular and engineered therapies that show potential to address serious or life-threatening conditions based on preliminary clinical evidence. This announcement was made on February 5, 2025, by Gradalis, Inc.

This first-in-class immunotherapy, designed to target clonal mutation signals that are contained within cancer cells, is the focus of the phase IIb VITAL trial in patients who have homologous recombination–proficient disease with high clonal tumor mutation burden. In this trial, gemogenovatucel-T was used as maintenance treatment of women with newly diagnosed, advanced stage IIIb or IV ovarian cancer who were in complete response after debulking surgery and front-line platinum-based doublet chemotherapy.

In the VITAL trial, gemogenovatucel-T showed a positive trend in the primary endpoint of recurrence-free survival in the overall population and a statistically significant improvement in the secondary endpoints of recurrence-free survival and overall survival in patients with the BRCA wild-type molecular profile. Additionally, phase I trial results in an “all-comer” clinical trial have shown signals of activity in 19 different tumor types, and some patients treated with gemogenovatucel-T remain in the study 48 months later.

BioSpace

---