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IMUNON Announces 11.1 Month Increase in Overall Survival in Patients with Newly Diagnosed, Advanced Ovarian Cancer Treated with IMNN-001
Phase 2 OVATION 2 Study of IMNN-001 administered with standard-of-care chemotherapy as first-line treatment demonstrates a hazard ratio of 0.74 in overall
About this update from Imunon, Inc.
[{"type":"text","content":"Phase 2 OVATION 2 Study of IMNN-001 administered with standard-of-care chemotherapy as first-line treatment demonstrates a hazard ratio of 0.74 in overall survival (OS) in the intent-to-treat patient population compared with the standard-of-care control armOS was extended by 15.7 months in patients receiving three or more doses of IMNN-001 in the 17-dose protocol Patients also receiving maintenance PARP inhibitor therapy demonstrated an OS hazard ratio of 0.41 in the IMNN-001 trial arm with median OS not yet reached at the time of data lockRobust and durable benefit of IMNN-001 observed in OS supported by a three-month improvement in the primary endpoint of progression-free survival (PFS)IMUNON expects to initiate a registrational study in Q1 2025 Conference call begins today at 8:30 a.m. Eastern time LAWRENCEVILLE, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, announces positive topline results from the Phase 2 OVATION 2 Study with IMNN-001 in patients with advanced ovarian cancer. OVATION 2 is a randomized study of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) inclusive of interval debulking or cytoreductive surgery compared with a control arm of standard-of-care NACT alone. IMNN-001 is the Company’s interleukin-12 (IL-12) immunotherapy based on its TheraPlas™ technology. Highlights from patients treated with IMNN-001 plus standard-of-care in a first-line treatment setting include: An 11.1 month increase in median OS compared with standard-of-care alone in the intent-to-treat population (ITT).A hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival.Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival.For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm. The...