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Importantly, we did not see any of the systemic toxicity [such as] cytokine release syndrome [CRS] or any of the barriers that have limited IL-12 therapies in the past.”

Jennifer Scalici, MD, professor, gynecologic oncology, Department of Gynecology and Obstetrics, Emory University School of Medicine, discusses findings from the phase 2 OVATION 2 trial (NCT03393884) evaluating IMNN-001 in combination with standard-of-care neoadjuvant and adjuvant chemotherapy vs chemotherapy alone in women with advanced ovarian cancer. Data from the study were presented at 

IMNN-001 is a nanoparticle-encased IL-12 DNA plasmid vector designed to enable cell transfection and IL-12 secretion. Enrolled patients were randomly assigned to receive IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy, or chemotherapy alone. The primary end point of the study was progression-free survival (PFS), and overall survival was a secondary end point. Notably, the study was not powered for statistical significance.

Results from the study showed that there was an 11.1-month improvement in OS in the IMNN-001 arm compared with chemotherapy alone, Scalici reports. The median OS was 40.5 months in the experimental arm vs 29.4 months in the control arm (HR, 0.74). The median PFS was 14.9 months for patients treated with the IMNN-001 regimen vs 11.9 months for those given chemotherapy alone (HR, 0.79).

Regarding safety, IMNN-001 was well tolerated, according to Scalici. No instances of CRS or other severe immune-related adverse effects (AEs) were reported. The most common AEs were abdominal discomfort, nausea, and vomiting, which Scalici notes are toxicities that are typically associated with intraperitoneal chemotherapy, adding that these toxicities were manageable.

Scalici highlights that, although the improvement in PFS was modest, the OS benefit was notable, particularly in the first-line setting for advanced ovarian cancer. Although not statistically significant, the OS data indicate a strong signal for efficacy, warranting further exploration in a larger, randomized trial, she concludes.

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Jennifer Scalici, MD, discusses data for IMNN-001plus chemotherapy in advanced ovarian cancer.

Jennifer Scalici, MD

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Dr Scalici on Data for IMNN-001 Plus SOC Chemotherapy in Advanced Ovarian Cancer