A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy

Trial ID # NCT02346747; VITAL
Phase II
Drug Class Immunotherapy: Vaccine/TGFbeta
Drug Name Gemogenovatucel-T
Alternate Drug Names Vigil, bi-shRNA-furin/GMCSF-expressing autologous tumor cell vaccine, bi-shRNA-furin and granulocyte macrophage colony stimulating factor augmented autologous tumor cell vaccine, FANG vaccine
Drugs in Trial Gemogenovatucel-T
Eligible Participant

Stage IIIb/IIIc/IV disease with CR after first-line therapy

Patients Enrolled

91

Therapy Setting

Maintenance

Study Design

Double Blind, Randomized

Endpoints

RFS, OS

Efficacy

VIGIL (n=47) vs Placebo (n=44):
RFS (from time of randomization): 11.5 vs 8.4 months, HR: 0.69, p=0.078

BRCA WT patients:
VIGIL (n=39) vs Placebo (n=28):
RFS (from time of randomization): 12.7 vs 8.0 months, HR: 0.49, p=0.014
RFS (from time of surgery/procurement): NR vs 14.8 months
OS: NR vs 41.4 months, HR: 0.42, p=0.02
Relapsed patients at median follow up of 38.6 months: 51 vs 79%

HRP patients:
VIGIL (n=25) vs Placebo (n=20):
RFS (from time of randomization): 10.6 vs 5.7 months, HR: 0.39 (0.20-0.75, p=0.007)
OS: NR vs 26.9 months, HR: 0.34 (0.14-0.83, p=0.019)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: none

Conclusion

Vigil immunotherapy as maintenance after first-line therapy in stage III–IV ovarian cancer is well tolerated and shows clinical benefit, particularly for BRCA WT patients and HRP patients

Reference

Rocconi RP et al. Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Oncol (2020) 21(12):1661-1672
https://pubmed.ncbi.nlm.nih.gov/33271095/

Rocconi RP et al. Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer. Gynecol Oncol (2021) 161(3):676-680
https://pubmed.ncbi.nlm.nih.gov/33715892/

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