Long-Term Follow-Up of Gemogenovatucel-T (Vigil) Survival and Molecular Signals of Immune Response in Recurrent Ovarian Cancer

Aim: To determine the relationship between gene expression profile (GEP) and overall survival (OS) by NanoString following treatment with Vigil. Patients and Methods: Recurrent ovarian cancer patients (n = 21) enrolled in prior clinical trials. Results: GEP stratified by TIS(HIGH) vs. TIS(LOW) demonstrated OS benefit (NR vs. 5.8 months HR 0.23; p = 0.0379), and in particular, MHC-II elevated baseline expression was correlated with OS advantage (p = 0.038). Moreover, 1-year OS was 75% in TIS(HIGH) patients vs. 25% in TIS(LOW) (p = 0.03795). OS was also correlated with positive γ-IFN ELISPOT response, 36.8 vs. 23.0 months (HR 0.19, p = 0.0098). Conclusion: Vigil demonstrates OS benefit in correlation with TIS(HIGH) score, elevated MHC-II expression and positive γ-IFN ELISPOT in recurrent ovarian cancer patients.