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

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

91

Maintenance

Double Blind, Randomized

RFS, OS

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: 0.41, p=0.011
OS: NR vs 26.9 months, HR: 0.42, p=0.020
3 year OS: 70 vs 40%

Exploratory analysis; CD39 status:
CD39 RNA levels above median:
VIGIL (n=23) vs Placebo (n=23):
RFS (from time of randomization): NR vs 8.1 months, p=0.00007
OS: NR vs 41.4 months, p=0.013

HRP and CD39 RNA levels above median:
VIGIL (n=11) vs Placebo (n=9):
RFS (from time of randomization): 21.1 vs 5.6 months, HR: 0.18, p=0.004
OS: NR vs 27 months, HR: 0.23, p=0.025

Serious AE: none
Grade 3-4 AE: none

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

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/

Walter A et al. Gemogenovatucel-T (Vigil) maintenance immunotherapy: 3-year survival benefit in homologous recombination proficient (HRP) ovarian cancer. Gynecol Oncol (2021) 163(3):459-464
https://pubmed.ncbi.nlm.nih.gov/34702567/

Rocconi RP et al. ENTPD1/CD39 as a predictive marker of treatment response to gemogenovatucel-T as maintenance therapy in newly diagnosed ovarian cancer. Commun Med (Lond) (2022) 2:106
https://pubmed.ncbi.nlm.nih.gov/36051466/