Highlights
- •Limited treatment options exist for homologous recombination proficient ovarian cancer.
- •Vigil is an anticancer immuno-therapeutic.
- •Vigil provides neoantigen education, GMCSF activation and TGFβ suppression reversal.
- •Vigil vs. placebo shows benefit of RFS and OS (HR = 0.386, p = 0.007; HR = 0.342, p = 0.019).
- •Vigil demonstrated no Grade 3/4 toxicity compared to placebo.
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
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Article info
Publication history
Published online: March 11, 2021
Accepted:
March 4,
2021
Received:
December 3,
2020
Identification
Copyright
© 2021 Published by Elsevier Inc.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Corrigendum to “Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer” [Gynecologic Oncology Volume 161, Issue 3, June 2021, Pages 676-680]Gynecologic OncologyVol. 169
- PreviewThe authors regret that there was an error on the demographics table (Table 1) in the published version. The number of neoadjuvant and adjuvant patients was incorrect. This error did not affect the results or interpretation of the manuscript, and did not alter the statistical significance of the primary endpoints (PFS and OS) of the study.
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