Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer.
BRCA
HRD
HRP
Homologous recombination
Ovarian cancer
Overall survival benefit
Relapse free survival benefit
Vigil immunotherapy
Journal
Gynecologic oncology
ISSN: 1095-6859
Titre abrégé: Gynecol Oncol
Pays: United States
ID NLM: 0365304
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
received:
03
12
2020
accepted:
04
03
2021
pubmed:
16
3
2021
medline:
4
1
2022
entrez:
15
3
2021
Statut:
ppublish
Résumé
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. 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. 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). Vigil exhibited clinical benefit in HRP molecular profile patients.
Identifiants
pubmed: 33715892
pii: S0090-8258(21)00229-8
doi: 10.1016/j.ygyno.2021.03.009
pii:
doi:
Substances chimiques
Modafinil
R3UK8X3U3D
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
676-680Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2021. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
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.