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15 Randomized double-blind placebo controlled trial of frontline maintenance vigil immunotherapy (VITAL study) in stage III/IV ovarian cancer: efficacy assessment in BRCA1/2-wt patients
  1. R Rocconi1,
  2. E Grosen2,
  3. S Ghamande3,
  4. J Chan4,
  5. M Barve5,
  6. J Oh6,
  7. D Tewari7,
  8. P Morris8,
  9. E Stevens9,
  10. J Bottsford-Miller9,
  11. M Tang10,
  12. P Aaron11,
  13. G Wallraven11,
  14. E Bognar11,
  15. L Manning11,
  16. J Nemunaitis11,
  17. B Slomovitz12,
  18. T Herzog13,
  19. B Monk14 and
  20. R Coleman15
  1. 1University of South Alabama – Mitchell Cancer Institute, USA
  2. 2Cancer Care Northwest, USA
  3. 3Georgia Regents University, USA
  4. 4California Pacific Medical Center Research Institute, USA
  5. 5Mary Crowley Cancer Research Centers, USA
  6. 6Texas Oncology, USA
  7. 7Kaiser Permanente, USA
  8. 8Nebraska Methodist Hospital, USA
  9. 9Billings Clinic, USA
  10. 10StatBeyond Consulting, LLC., USA
  11. 11Gradalis, Inc., USA
  12. 12University of Miami – Sylvester Comprehensive Cancer Center, USA
  13. 13University of Cincinnati Cancer Institute, USA
  14. 14Arizona Oncology, USA
  15. 15MD Anderson Cancer Center, USA


Introduction Vigil is an autologous tumor cell vaccine constructed from tumor tissue transfected with a DNA plasmid encoding GMCSF and bi-shRNA-furin thereby reducing TGFβ expression.

Methods A randomized double-blind placebo-controlled trial of Vigil was performed in advanced stage frontline (1L) Ovarian Cancer (OC) patients. Relapse-free survival (RFS), overall survival (OS), and safety were endpoints. Patients were randomized [1:1 to placebo (control group, CG) or Vigil (Vigil group, VG), 1 × 10e7 cells/dose for up to 12 doses] after complete response to 1L surgery and chemotherapy.

Abstract 15 Figure 1

RFS from randomization. (A) RFS of all PP. (B) RFS of BRCA1/2-wt population

Results 91 patients were randomized in the per-protocol population (PP), (VG: n=46; CG: n=45). VG demonstrated no Grade 3 or 4 toxicity. From time of randomization median RFS (mRFS) for all 91 patients was favorable in the VG (HR 0.67, one-sided p 0.065). All 91 patients were tested for BRCA1/2 status. An advantage in mRFS was seen in the BRCA1/2-wt patients in VG (12.7 mo) compared to CG (8 mo), (HR 0.493, 90% CI [0.287 to 0.846], one-sided p 0.014) from time of randomization as well as OS benefit in VG (median not reached) vs. CG (41.4 mo) (HR of 0.417, 90% CI [0.202 to 0.86], p 0.02). 51% BRCA1/2-wt Vigil treated patients relapsed compared to 79% of placebo (median follow-up of 38.6 mo for PP). Homologous recombination deficiency status (HRD) and further determination of predictive biomarkers of response are underway.

Conclusion Vigil immunotherapy as 1L maintenance in Stage III/IV ovarian cancer is well tolerated and showed significant RFS clinical benefit, particularly in BRCA1/2-wt disease.

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