Dr Thaker on IMNN-001 Plus Neoadjuvant Chemo in Newly Diagnosed Ovarian Cancer

“We [improved] PFS by 3 months [with IMN-001 plus neoadjuvant chemotherapy vs chemotherapy alone]. However, most importantly, we [increased] OS by 13 months. We’re optimistic that as the data continue to mature, we may see even better OS.”

Premal H. Thaker, MD, MS, the David G. and Lynn Mutch Distinguished Professor of Obstetrics and Gynecology, director of Gynecological Oncology Clinical Research, and interim chief of the Division of Gynecologic Oncology at Siteman Cancer Center of Washington University in St. Louis, discussed findings from an updated survival analysis of the phase 1/2 OVATION-2 trial (NCT03393884) of IMN-001 in combination with neoadjuvant chemotherapy in patients with newly diagnosed epithelial ovarian cancer.

In OVATION-2, patients received standard-of-care neoadjuvant chemotherapy alone or in combination with the novel IL-12 gene therapy IMN-001. The primary end points in phase 2 were safety and progression-free survival (PFS). Secondary end points included overall survival (OS), overall response rate, surgical response, chemotherapy response score, and serologic response rates.

Findings from OVATION-2 presented during the 2025 ASCO Annual Meeting showed that patients in the investigational arm (n = 58) achieved a median PFS of 14.9 months (95% CI, 12.55-21.19) vs 11.9 months (95% CI, 10.09-14.92) in the control arm, representing a difference of 3 months (HR, 0.79; 95% CI, 0.51-1.23; P = .2933), Thaker said. Notably, with 31 months of follow-up, the median OS was 46.0 months (95% CI, 39.20-not evaluable [NE]) in the investigational arm compared with 33.0 months (95% CI, 27.14-NE) for a difference of 13 months (HR, 0.69; 0.40-1.19; P = .1865), she added.

Study authors are excited by the findings, Thaker said. She noted that the OS data are not yet fully mature and the OS may continue to improve over time in favor of the investigational arm. These findings led investigators to initiate the randomized phase 3 OVATION-3 study (NCT06915025) in a larger patient population, she concluded.