Core Insights - IMUNON, Inc. announced positive topline results from the Phase 2 OVATION 2 Study of IMNN-001, demonstrating significant improvements in overall survival (OS) and progression-free survival (PFS) for patients with advanced ovarian cancer [1][4] Study Results - The Phase 2 OVATION 2 Study showed a hazard ratio of 0.74 for OS in the intent-to-treat (ITT) population, indicating a 35% improvement in survival compared to standard-of-care [2][3] - Patients receiving three or more doses of IMNN-001 experienced a median OS increase of 15.7 months, with a hazard ratio of 0.64, representing a 56% improvement in survival [2] - For nearly 40% of participants treated with a PARP inhibitor, the hazard ratio further decreased to 0.41, with median OS not yet reached in the IMNN-001 arm compared to 37.1 months in the control arm [2] Progression-Free Survival - The primary endpoint of the trial, PFS, showed a three-month improvement compared to standard-of-care, with a hazard ratio of 0.79, indicating a 27% improvement in delaying disease progression [3] Future Plans - IMUNON plans to initiate a registrational study in Q1 2025 and will hold an End-of-Phase 2 meeting with the U.S. FDA to discuss the protocol for a Phase 3 study [1][6] Company Background - IMUNON is a clinical-stage biotechnology company focused on innovative treatments utilizing non-viral DNA technology, with IMNN-001 being a key product in development for advanced ovarian cancer [12][13]
IMUNON Announces 11.1 Month Increase in Overall Survival in Patients with Newly Diagnosed, Advanced Ovarian Cancer Treated with IMNN-001