On July 30, 2024, Imunon, Inc. (IMNN) announced positive topline results for the Phase 2 OVATION 2 Trial of IMNN-001 in patients with advanced ovarian cancer. The company reported an 11.1 month increase in median overall survival (OS) compared with standard-of-care alone in the intent-to-treat (ITT) population with a hazard ratio (HR) of 0.74, which indicates a 35% improvement in survival. For the 40% of trial participants treated with a PARP inhibitor, the HR dropped to 0.41, with a median OS in the IMNN-001 treatment arm that had not yet been reached at the time of database lock, compared with a median OS of 37.1 months in the standard-of-care arm. The company will be meeting with the FDA to discuss the protocol for a Phase 3 study, which we anticipate initiating in the first quarter of 2025.

15 Aug 2024
IMNN: Positive Results for OVATION 2 Trial Supports Advancing IMNN-001 Into Phase 3 Study

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IMNN: Positive Results for OVATION 2 Trial Supports Advancing IMNN-001 Into Phase 3 Study
On July 30, 2024, Imunon, Inc. (IMNN) announced positive topline results for the Phase 2 OVATION 2 Trial of IMNN-001 in patients with advanced ovarian cancer. The company reported an 11.1 month increase in median overall survival (OS) compared with standard-of-care alone in the intent-to-treat (ITT) population with a hazard ratio (HR) of 0.74, which indicates a 35% improvement in survival. For the 40% of trial participants treated with a PARP inhibitor, the HR dropped to 0.41, with a median OS in the IMNN-001 treatment arm that had not yet been reached at the time of database lock, compared with a median OS of 37.1 months in the standard-of-care arm. The company will be meeting with the FDA to discuss the protocol for a Phase 3 study, which we anticipate initiating in the first quarter of 2025.