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 language | English (US) |
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Pages (from-to) | 676-680 |
Number of pages | 5 |
Journal | Gynecologic oncology |
Volume | 161 |
Issue number | 3 |
DOIs | |
State | Published - Jun 2021 |
Keywords
- BRCA
- HRD
- HRP
- Homologous recombination
- Ovarian cancer
- Overall survival benefit
- Relapse free survival benefit
- Vigil immunotherapy
ASJC Scopus subject areas
- Oncology
- Obstetrics and Gynecology