The company received Fast Track designation from the FDA for GEN-1, a DNA-mediated interleukin-12 (IL-12) immunotherapy.
New research presented by Celsion Corporation has found promising results for GEN-1, a DNA-mediated interleukin-12 (IL-12) immunotherapy, in the treatment of advanced ovarian cancer.1,2 The company has received Fast Track designation from the FDA for GEN-1.1
A research poster was presented at the Society of Gynecologic Oncology 2021 Virtual Annual Meeting on Women’s Cancer.2 It describes findings from the OVATION 2 study, which combines GEN-1 with standard-of-care neoadjuvant chemotherapy in patients newly diagnosed with stage III/IV ovarian cancer.1,2
The OVATION 2 study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival, the primary endpoint, when comparing the treatment arm with the control arm. In early March, the company announced it had enrolled approximately one-third of the anticipated 110 patients to be enrolled in the study, 20 of whom are in the treatment arm and 14 of whom are the control.1
According to Celsion, neoadjuvant chemotherapy is designed to shrink the cancer as much as possible for optimal surgical removal following 3 cycles of chemotherapy. After receiving chemotherapy, patients undergo interval debulking surgery, following by 3 adjuvant cycles of chemotherapy and up to 9 additional weekly treatments with GEN-1, the goal of which is to delay progression and improve overall survival.1
According to the company, 28 patients have had their interval debulking surgery. Of these, 81% of patients treated with GEN-1 had a microscopically margin-negative (R0) resection, indicating a complete resection in which no gross or microscopic tumor remains in the tumor bed. Furthermore, 58% of patients in the control arm had an R0 resection.1
This interim data represents a 40% improvement in R0 resection rates for GEN-1 patients compared with control arm patients. Notably, these findings are consistent with the reported improvements in resection scores noted in the phase 1 OVATION 1 study.1
Recruitment for eligible patients is ongoing for phase 2 of the study. Overall survival endpoint results are expected in the third quarter of 2021, with progression-free survival endpoint data projected for the first quarter of 2023.2