Core Insights - IMUNON, Inc. announced positive topline results from the Phase 2 OVATION 2 Study of IMNN-001, demonstrating a significant improvement in overall survival (OS) for patients with advanced ovarian cancer compared to standard-of-care treatment [1][3][8] - The study showed a hazard ratio of 0.74 in the intent-to-treat population, indicating a 35% improvement in survival, with a median OS increase of 11.1 months [7][19] - IMUNON plans to initiate a registrational study in Q1 2025 and is preparing for an End-of-Phase 2 meeting with the U.S. FDA [1][10] Study Design and Results - The OVATION 2 Study was a randomized trial evaluating the safety and efficacy of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer [2][12] - A total of 112 patients were enrolled and randomized 1:1 to receive either IMNN-001 plus standard-of-care chemotherapy or standard-of-care alone [2] - The primary endpoint of progression-free survival (PFS) showed a three-month improvement for the IMNN-001 treatment arm, with a hazard ratio of 0.79, indicating a 27% improvement in delaying progression [17] Clinical Significance - The results indicate that the addition of IMNN-001 could extend median OS from 29 months with standard treatment to 40 months, which is considered clinically meaningful [3][19] - Among patients receiving three or more doses of IMNN-001, there was a further increase in median OS by 15.7 months, with a hazard ratio of 0.64, representing a 56% improvement in survival [7][9] - For patients treated with a PARP inhibitor, the hazard ratio decreased to 0.41, with median OS not yet reached in the IMNN-001 arm compared to 37.1 months in the control arm [7][19] Future Directions - IMUNON aims to advance IMNN-001 into a Phase 3 pivotal study as soon as possible, with plans to present full study results at an upcoming medical conference [8][10] - The company is focused on addressing the unmet medical needs of over 300,000 women diagnosed with advanced ovarian cancer annually [8][12]
IMUNON Announces 11.1 Month Increase in Overall Survival in Patients with Newly Diagnosed, Advanced Ovarian Cancer Treated with IMNN-001