Open Label Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage III/IV Ovarian Cancer

Trial ID # NCT01309230
Phase II
Drug Class Immunotherapy: Vaccine
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
Patients Enrolled

42

Therapy Setting

Maintenance

Study Design

Open-Label, Randomized

Endpoints

RFS, evaluated per RECIST

Efficacy

FANG maint vs Placebo:

RFS (from time of procurement): mean/median: 27.5/20.1 (n=31) vs 16.0/12.6 months (n=11), HR: 0.43 (0.19-0.96, p=0.039)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: none

Conclusion

FANG vaccine shows encouraging anti-tumor activity and increased RFS with remarkable safety

Reference

Oh J et al. Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer. Gynecol Oncol (2016) 143(3):504-510
https://www.ncbi.nlm.nih.gov/pubmed/27678295