Study Demonstrates Promising Results for GEN-1 in Advanced Ovarian Cancer

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

REFERENCE

1. Poster on Celsion Corporation’s Phase I/II OVATION 2 Study to be Presented at the Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer [news release]. Celsion Corporation; March 2, 2021. Accessed March 22, 2021. https://www.globenewswire.com/news-release/2021/03/02/2185367/0/en/Poster-on-Celsion-Corporation-s-Phase-I-II-OVATION-2-Study-to-be-Presented-at-the-Society-of-Gynecologic-Oncology-Virtual-Annual-Meeting-on-Women-s-Cancer.html
2. Thaker PH, Holloway RW, Kuroki L, et al.. A phase 1/11 study evaluating intraperitoneal GEN-1 in combination with neoadjuvant chemotherapy in patients with newly diagnosed advanced epithelial ovarian cancer (EOC). Poster presented at: SGO 2021 Virtual Annual Meeting on Women’s Cancer. March 19, 2021. Accessed March 23, 2021. https://sgomtg.us2.pathable.com/meetings/virtual/hjtaFHqgCmejPGsrs