IMUNON advances IMNN-001 ovarian cancer program with Phase 2 survival data

• IMUNON (NASDAQ:IMNN) reported updated survival results from the Phase 2 OVATION 2 study of IMNN-001 in advanced ovarian cancer.
• Median overall survival was 45.1 months with IMNN-001 plus chemotherapy versus 30.4 months with standard treatment alone, although the study was not designed to statistically evaluate survival.
• The company’s Phase 3 OVATION 3 trial is enrolling approximately 500 patients, with enrollment expected to complete in the first quarter of 2029.

IMUNON (NASDAQ:IMNN) presented Phase 2 survival results and Phase 3 enrollment updates for IMNN-001, its investigational therapy for advanced ovarian cancer.

The company reported results from the 112-patient randomized OVATION 2 study, which evaluated IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy compared with standard-of-care chemotherapy alone.

Median overall survival was 45.1 months for patients receiving IMNN-001 plus chemotherapy compared with 30.4 months for patients receiving standard treatment alone, representing a difference of 14.7 months.

IMUNON noted that OVATION 2 was not powered to assess overall survival, meaning the survival analysis was exploratory rather than a definitive efficacy measure.

The company is continuing development through OVATION 3, a randomized Phase 3 trial expected to enroll approximately 500 patients. Overall survival is the primary endpoint, with two planned event-driven interim analyses.

IMUNON said enrollment is progressing at approximately 0.5 patients per site per month, above the original planning assumption of 0.3 patients per site per month.

The company expects enrollment completion in the first quarter of 2029.

In a separate preliminary minimal residual disease study, 4 of 9 evaluable patients receiving IMNN-001 had residual disease compared with 6 of 9 patients in the control group.

IMUNON said the small sample size prevents conclusions regarding treatment effectiveness.

The company also reported that OVATION 2 showed no cases of cytokine release syndrome or serious systemic immune-related adverse events.