Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2021 Jun;161(3):676-680.
doi: 10.1016/j.ygyno.2021.03.009. Epub 2021 Mar 11.

Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer

Rodney P Rocconi  1 , Bradley J Monk  2 , Adam Walter  3 , Thomas J Herzog  4 , Evanthia Galanis  5 , Luisa Manning  6 , Ernest Bognar  6 , Gladice Wallraven  6 , Laura Stanbery  6 , Phylicia Aaron  6 , Neil Senzer  6 , Robert L Coleman  7 , John Nemunaitis  8
Affiliations
Clinical Trial

Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer

Rodney P Rocconi et al. Gynecol Oncol. 2021 Jun.

Erratum in

Abstract

Objective: Recently, Vigil showed significant clinical benefit with improvement in relapse free (RFS) and overall survival (OS) in pre-planned subgroup analysis in stage III/IV newly diagnosed ovarian cancer patients with BRCA wild type (BRCA-wt) molecular profile. Here we analyze homologous recombination (HR) status of patients enrolled in the Phase 2b VITAL study and determine clinical benefit of Vigil in HR proficient (P) patients.

Methods: Patients were previously enrolled in a Phase 2b, double-blind, placebo-controlled trial. All were in complete response with Stage III/IV high grade serious, endometroid or clear cell ovarian cancer. HR status was determined using MyChoice®CDx score (<42 = HRP) (Myriad Genetics, Inc., UT). Post-hoc analyses were carried out using Kaplan Meier and restricted mean survival time (RMST) analysis to evaluate RFS and OS based on HR deficiency (D) status.

Results: RFS was improved with Vigil (n = 25) in HRP patients compared to placebo (n = 20) (HR = 0.386; 90% CI 0.199-0.750; p = 0.007), results were verified by RMST (p = 0.017). Similarly, OS benefit was observed in Vigil group compared to placebo (HR = 0.342; 90% CI 0.141-0.832; p = 0.019). Results with OS were also verified with RMST (p = 0.008).

Conclusion: Vigil exhibited clinical benefit in HRP molecular profile patients.

Keywords: BRCA; HRD; HRP; Homologous recombination; Ovarian cancer; Overall survival benefit; Relapse free survival benefit; Vigil immunotherapy.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest RPR reports sponsored research related to this work. BJM reports personal fees from Abbvie, Advaxis, Agenus, Amgen, Aravive, AstraZeneca, Asymmetric Therapeutics, Boston Biomedical, ChemoCare, ChemoID, Circulogene, Clovis, Conjupro, Easai, Geistlich, Genmab/Seattle Genetics, GOG Foundation, Gradalis, ImmunoGen, Immunomedics, Incyte, Janssen/ Johnson & Johnson, Laekna Health Care, Mateon (formally Oxigene), Merck, Mersana, Myriad, Nucana, Oncomed, Oncoquest, Oncosec, Perthera, Pfizer, Precision Oncology, Puma, Regeneron, Roche/ Genentech, Samumed, Takeda, Tesaro/GSK, VBL, and Vigeo, outside the submitted work. EG reports personal fees or grant funding from MedImmune, Gradalis, Agios Pharmaceuticals, Karyopharm, Tracon, Genentech, Bristol Myers Squibb, outside the submitted work. All other authors declare no competing interests.

Publication types

MeSH terms