IMNN-001 May Show Enhanced Benefit in HRD-Positive Ovarian Cancer Subgroup

Premal H. Thaker, MD, MS, spoke with CancerNetwork^® at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting about subgroup findings and potential next steps for research associated with IMNN-001 for patients with advanced epithelial ovarian cancer in the phase 1/2 OVATION-2 study (NCT03393884). During a rapid oral abstract session at the meeting, Thaker presented updated survival analysis findings from OVATION-2, which evaluated the agent plus neoadjuvant chemotherapy for this population.¹

Regarding potential patient subgroups that may benefit from treatment with IMNN-001, Thaker, 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 School of Medicine in St Louis, Missouri, highlighted potentially improved outcomes in those with homologous recombination deficiency (HRD)–positive disease or BRCA mutations. She stated that the study was not powered to verify specific subgroup benefits, and that the future phase 3 OVATION-3 trial may further determine efficacy signals associated with IMNN-001 in this ovarian cancer population.

Additionally, Thaker said that the OVATION-2 trial included a translational sample analysis, the data of which are slated for presentation at the European Society for Medical Oncology (ESMO) Gynaecological Cancers Congress 2025.² Findings from this translational analysis may corroborate the clinical results that have been reported so far with IMNN-001.

Transcript:

We do think patients who have an HRD signature or a BRCA mutation may even do better with this therapy—at least, that’s what we see from our subset analysis. It’s not powered, so that’s why, in the actual [phase 3 OVATION-3 trial (NCT06915025)], we’re trying to power for that more effectively, and do that earlier in the trial. If we do see a signal, hopefully, that could be a path for us to get an accelerated approval quicker, so we can actually get this to patients more expeditiously.

We’ve always known that ovarian cancer is a cancer that should be responsive to immunotherapy, and now that we’re able to affect more parts of our immune system, I think that’s what we’re seeing much more [often]. Then, on top of that, we did have a subset from OVATION-2 where we looked at translational samples, and those data should be released for [the 2025 ESMO congress in June] in Vienna, Austria. There should be a poster talking about the translational effects that we see, which also corroborates what findings we’re seeing clinically.

References

1. Thaker P, Richardson D, Hagemann A, et al. A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): updated survival analysis from OVATION-2 trial. J Clin Oncol. 2025;43(suppl 16):5516. doi:10.1200/JCO.2025.43.16_suppl.5516
2. Imunon invited to present translational data in supporting remarkable phase 2 ovarian cancer survival results at ESMO Gynaecological Cancers Congress 2025. News release. Imunon, Inc. May 27, 2025. Accessed June 2, 2025. https://tinyurl.com/rwakj934