Investigational Immunotherapy Shows Promise for Treatment of Advanced Ovarian Cancer

Pharmacy Practice in Focus: OncologyApril 2021
Volume 3
Issue 2
Pages: 47

FDA grants a fast track designation to GEN-1, a DNA-mediated IL-12 immunotherapy.

New research indicates promising results for GEN-1, a DNA-mediated interleukin-12 (IL-12) immunotherapy being developed by Celsion Corporation for the treatment of advanced ovarian cancer.1,2

A poster presented at the Society of Gynecologic Oncology 2021 Virtual Annual Meeting on Women’s Cancer described findings from the phase 1/2 OVATION 2 study (NCT03393884). The trial combines GEN-1 with standard-of-care neoadjuvant chemotherapy in patients who have a new diagnosis of stage III/IV ovarian cancer.1-3

OVATION 2, an open-label, 1:1 randomized trial, is 80% powered to show the equivalent of a 33% improvement in progression-free survival, the primary end point, when comparing the treatment arm with the control arm. In early March, Celsion announced it had enrolled 34 of 130 anticipated participants, including 20 in the treatment arm and 14 in the control arm.1,3

According to the company, 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, followed by 3 adjuvant cycles of chemotherapy and up to 9 additional weekly treatments with GEN-1, with the goal of delaying progression and improving overall survival.1

Twenty-eight patients have had their interval debulking surgery thus far. 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. These interim data represent a 40% improvement in R0 resection rates for GEN-1 patients compared with control arm patients. Notably, the findings are consistent with the reported improvements in resection scores that investigators observed in the phase 1 OVATION 1 study.1 Recruitment for eligible patients is ongoing for phase 2 of the OVATION 2 study. Overall survival results are expected in the third quarter of 2021, with progression- free survival end point data projected for the first quarter of 2023.2

The company has received a fast track designation from the FDA for GEN-1.1


  1. Poster on Celsion Corporation’s phase I/II OVATION 2 Study to be presented at the Society of Gyne- cologic Oncology Virtual Annual Meeting on Women’s Cancer. News release. GlobeNewswire. March 2, 2021. Accessed March 22, 2021. 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. Poster presented at: Society of Gynecologic Oncology 2021 Virtual Annual Meeting
    on Women’s Cancer; March 19-25, 2021. Accessed March 23, 2021. meetings/virtual/hjtaFHqgCmejPGsrs
  3. Study of GEN-1 with NACT for treatment of ovarian cancer (OVATION 2). Updated March 1, 2021. Accessed March 23, 2021. ION+2&draw=2&rank=1
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