Imunon announces increase in survival in patients treated with IMNN-001

Imunon 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 inclusive of interval debulking or cytoreductive surgery compared with a control arm of standard-of-care NACT alone. 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. 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 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 PFS results, the trial’s primary endpoint, support the OS results with: A three-month improvement in PFS compared with standard-of-care alone. A hazard ratio in the intent-to-treat population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm. OS 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 lock.