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Protocol in Place for Phase 3 Trial of IMNN-001 in Ovarian Cancer
On March 24, 2025, Imunon, Inc. (NASDAQ:IMNN) announced it reached alignment with the U.S. FDA on the protocol for a Phase 3 clinical trial, referred to as OVATION 3, of its lead candidate IMNN-001 for the treatment of women with newly diagnosed advanced ovarian cancer. Trial sites are currently being initiated with the first patient to be enrolled in the near term.
The following slide provides the overall design of the trial. Eligible patients will have either Stage IIIc and IV advanced ovarian cancer and will be randomized to receive neoadjuvant chemotherapy (NACT), interval debulking surgery, and adjuvant chemotherapy. Patients who are positive for homologous recombination deficiency (HDR) are also eligible and will receive poly ADP-ribose polymerase (PARP) inhibitor therapy as part of standard-of-care (SOC) maintenance therapy. The primary endpoint is overall survival (OS), with secondary endpoints evaluating surgical response score, chemotherapy response score, clinical response (ORR), and time to second-line treatment.
The company is utilizing a statistical design with two planned interim analyses. The goal is to minimize risk and maximize the chance for success. The FDA has agreed with both the overall study design and the statistical plan, which in the literature is referred to as a Group Sequential Design (GSD) (Hatfield et al., 2016). GSD has been utilized in a number of other clinical trials. For example, in a study of blinatumomab (a CD3/CD19 bi-specific T cell engager) in children with high-risk first-relapse B cell acute lymphoblastic lymphoma (B-ALL) the trial was terminated during the first prespecified interim analysis after only enrolling half of its maximum sample size as children receiving blinatumomab had significantly improved event-free survival compared to those receiving standard chemotherapy (Locatelli et al., 2021). Thus, we do not anticipate any additional regulatory risk from the use of a GSD in the OVATION 3 trial.
The study was designed to maximize operational flexibility as it is powered at >95% to examine either a 250-patient cohort of HRD positive individuals or a 500-patient all-comers population. The company has decided to initially focus on the HRD positive subgroup as it potentially offers cost savings of up to 40% and could lead to a data readout up to two years earlier. HRD positive patients constitute approximately 50% of the advanced ovarian cancer population, thus it is still a sizeable market opportunity. The company is still committed to examining IMNN-001 in a broader population of patients, however that will need to come at a later time when sufficient financing is available to conduct that study. The decision to target the HRD positive subgroup will help to conserve cash, targeting the highest probability subgroup, and delivering results as quickly as possible. In summary, this design allows Imunon to decrease the initial investment required, decrease the timeline to data readout, and allows the company to be more aggressive with site engagement.