FDA Grants Fast Track Designation to GEN-1 Immunotherapy for Treatment of Advanced Ovarian Cancer

The FDA granted fast track designation to a DNA-mediated interleukin-12 (IL-12) immunotherapy, GEN-1, to treat patients with advanced ovarian cancer, according to a press release from Celsion Corporation.

The drug is currently in phase 2 development and was designed using Celsion’s non-viral nanoparticle delivery system platform, TheraPlas.

“Fast Track designation is an important step in developing GEN-1 for advanced ovarian cancer. Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market,” Michael H. Tardugno, chairman, president, and chief executive officer of Celsion, said in a press release. “Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical trial design.”

Currently, GEN-1 is being investigated in the phase 1/2 OVATION 2 study (NCT03393884) investigating the combination of GEN-1 with standard-of-care neoadjuvant chemotherapy to treat patients with newly diagnosed stage III or IV ovarian cancer. With neoadjuvant chemotherapy, the goal is to shrink the tumor for 3 cycles to allow for surgical removal.

In this open-label, 1:1 randomized trial, the population underwent interval debulking surgery after neoadjuvant chemotherapy, followed by 3 cycles of chemotherapy and up to 9 cycles of treatment with GEN-1. The primary end point of the trial is progression-free survival improvement with active treatment versus the control arm, with attention also paid to overall survival.

Data for the phase 1 portion of the OVATION 2 trial was shared with the FDA prior to the fast track designation, finding a complete tumor resection was achieved in 7 of the 8 patients (88%) receiving GEN-1 treatment. The control arm featuring treatment with neoadjuvant chemotherapy saw a complete tumor resection rate of 50%.

“In addition, should criteria be met, Fast Track-designated drugs are eligible for rolling review, a process whereby the drug’s sponsor can separately submit sections of its New Drug Application to the FDA,” Tardugno said. “They also are eligible for accelerated approval and priority review, under which drugs for serious conditions fulfilling an unmet medical need can be approved based on a surrogate end point. We are optimistic that GEN-1 represents a game-changer for women with advanced ovarian cancer who have limited treatment options.”

The completed phase 1b dose-escalation OVATION 1 study also saw 100% of patients in the high-dose cohort experience a complete or partial response. Moreover, in the lower-dose cohort, 67% of patients experienced a complete or partial response to treatment. The high-dose population had a complete tumor resection rate of 88% compared to 33% in the lower-dose population.

When comparing data from the OVATION 1 study to a synthetic control arm, research found that the GEN-1 arm almost doubled control of cancer compared with patients in the synthetic control arm. With that being said, the small sample size kept this data form being statistically significant.

The FDA emphasizes that a fast-track designation “must show some advantage over available therapy.” This can include “showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes; avoiding serious side effects of an available therapy; or decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment.”

Reference:

Celsion Corporation Receives FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer. News release. Celsion Corporation. Published February 22, 2021. Accessed February 22, 2021. https://www.globenewswire.com/news-release/2021/02/22/2179451/0/en/Celsion-Corporation-Receives-FDA-Fast-Track-Designation-for-GEN-1-in-Advanced-Ovarian-Cancer.html