Rodney P Rocconi1, Bradley J Monk2, Adam Walter3, Thomas J Herzog4, Evanthia Galanis5, Luisa Manning6, Ernest Bognar6, Gladice Wallraven6, Laura Stanbery6, Phylicia Aaron6, Neil Senzer6, Robert L Coleman7, John Nemunaitis8. 1. University of South Alabama - Mitchell Cancer Institute, Mobile, AL, United States of America. 2. Arizona Oncology, Phoenix, AZ, United States of America. 3. ProMedica, Toledo, OH, United States of America. 4. University of Cincinnati Cancer Center, Cincinnati, OH, United States of America. 5. Mayo Clinic, Rochester, MN, United States of America. 6. Gradalis, Inc., Carrollton, TX, United States of America. 7. US Oncology Research, The Woodlands, TX, United States of America. 8. Gradalis, Inc., Carrollton, TX, United States of America. Electronic address: jnemunaitis@gradalisinc.com.
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.
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.
Authors: Elyssa Sliheet; Molly Robinson; Susan Morand; Khalil Choucair; David Willoughby; Laura Stanbery; Phylicia Aaron; Ernest Bognar; John Nemunaitis Journal: Cancer Gene Ther Date: 2021-11-16 Impact factor: 5.854
Authors: Justin Fortune Creeden; Nisha S Nanavaty; Katelyn R Einloth; Cassidy E Gillman; Laura Stanbery; Danae M Hamouda; Lance Dworkin; John Nemunaitis Journal: BMC Cancer Date: 2021-10-28 Impact factor: 4.430
Authors: Rodney P Rocconi; Laura Stanbery; Min Tang; Adam Walter; Bradley J Monk; Thomas J Herzog; Robert L Coleman; Luisa Manning; Gladice Wallraven; Staci Horvath; Ernest Bognar; Neil Senzer; Scott Brun; John Nemunaitis Journal: Commun Med (Lond) Date: 2022-08-29