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

Rodney P. Rocconi, Bradley J. Monk, Adam Walter, Thomas J. Herzog, Evanthia Galanis, Luisa Manning, Ernest Bognar, Gladice Wallraven, Laura Stanbery, Phylicia Aaron, Neil Senzer, Robert L. Coleman, John Nemunaitis

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
JournalGynecologic oncology
DOIs
StateAccepted/In press - 2021

Keywords

  • BRCA
  • Homologous recombination
  • HRD
  • HRP
  • Ovarian cancer
  • Overall survival benefit
  • Relapse free survival benefit
  • Vigil immunotherapy

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Fingerprint Dive into the research topics of 'Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer'. Together they form a unique fingerprint.

Cite this