Gemogenovatucel-T (Vigil) Immunotherapy as Maintenance in Frontline Stage III/IV Ovarian Cancer (VITAL): A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Trial

摘要

Standard-of-care treatment for stages III and IV newly diagnosed ovarian cancer involves primary debulking surgery followed by adjuvant paclitaxel and carboplatin or neoadjuvant chemotherapy with interval debulking surgery. Despite this protocol commonly resulting in complete remission, approximately 75% of patients will relapse within 2 years. Poly (ADP-ribose) polymerase (PARP) inhibitors are indicated as frontline maintenance for ovarian cancer but are much more efficacious in patients with BRCA germline and somatic mutations. Gemogenovatucel-T is an autologous tumor cell vaccine manufactured from harvested tumor tissue that specifically reduces expression of furin and downstream transforming growth factors beta 1 and beta 2. Phase 1 testing of gemogenovatucel-T in recurrent or refractory solid tumors showed safe administration and upregulation of immune response to self-tumor antigens, while a recurrence-free survival benefit was shown in a phase 2a study of gemogenovatucel-T as frontline maintenance therapy in stage III or IV resectable ovarian cancer.