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

Rodney P Rocconi; Laura Stanbery; Luciana Madeira da Silva; Robert A Barrington; Phylicia Aaron; Luisa Manning; Staci Horvath; Gladice Wallraven; Ernest Bognar; Adam Walter; John Nemunaitis

doi:10.3390/vaccines9080894

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

Vaccines (Basel). 2021 Aug 12;9(8):894. doi: 10.3390/vaccines9080894.

Affiliations

¹ Mitchell Cancer Institute, Division of Gynecologic Oncology, University of South Alabama, Mobile, AL 36604, USA.
² Gradalis, Inc., 2545 Golden Bear Drive, Suite 110, Carrollton, TX 75006, USA.
³ Department of Microbiology and Immunology, University of South Alabama, Mobile, AL 36688, USA.
⁴ Promedica, Sylvania, OH 43560, USA.

Abstract

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.

Keywords: NanoString; TIS; Vigil; gene expression profile; immune response; immunotherapy; ovarian cancer.