IMMN-001 Shows Promise in Treating Ovarian Cancer, Phase 2 Study Shows

Ovarian cancer: © Dr_Microbe - stock.adobe.com

IMMN-001, an interleukin-12 immunotherapy, led to an 11.1-month increase in median overall survival (OS) vs the standard of care in patients with advanced ovarian cancer, according to findings from the phase 2 OVATION 2 study (NCT03393884).¹ This improvement correlated with a 35% improvement in survival (HR, 0.74).

Further, among the 90% of patients who received at least 20% of the specified treatment protocol, there was a 15.7-month increase in median OS, demonstrating a 56% improvement in survival (HR, 0.64). Among almost 40% of patients treated with a PARP inhibitor, the median OS had not yet been reached (HR, 0.41) compared with a median OS of 37.1 months among patients treated with the standard-of-care (SOC).

“These strong and clinically meaningful phase 2 results are highly encouraging, suggesting that IMNN-001 may improve the outcomes for women with advanced ovarian cancer. In the near term, we look forward to advancing our therapeutic into a phase 3 pivotal study as soon as possible,” said Stacy Lindborg, PhD, president and chief executive officer of Imunon, in a press release. “Advancements in treatment options for advanced ovarian cancer in women who require neoadjuvant treatment have been limited over the years, and these patients continue to have poor prognoses. Our goal is for IMNN-001 to play an important role in the treatment regimen for the more than 300,000 women diagnosed with this deadly disease.”

Additionally, there were improvements observed in progression-free survival (PFS) in addition to OS, including a 3-month improvement in PFS compared with the SOC and 27% (HR, 0.79) improvement in disease progression in the IMNN-001 arm.

About the Phase 2 OVATION 2 Study

The phase 2 OVATION 2 study has an estimated enrollment of 130 patients across 21 locations in the US and Canada.² Patients were randomized to receive paclitaxel and carboplatin plus IMNN-001 or paclitaxel and carboplatin alone. The study’s primary end point is PFS.

Patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma were eligible for enrollment in the study if they had adequate bone marrow, renal, hepatic, and neurologic function; an ECOG performance status of 0 to 2; and were free of active infection. Those who previously received treatment with IMNN-001, currently receiving treatment for active autoimmune disease, have other invasive malignancies, or have received prior radiotherapy or chemotherapy were not eligible for enrollment.

The study has an estimated completion date of December 31, 2024.

REFERENCES:

1. Imunon announces 11.1 month increase in overall survival in patients with newly diagnosed, advanced ovarian cancer treated with IMNN-001. News release. Imunon Inc. July 30, 2024. Accessed August 1, 2024. https://tinyurl.com/bdhtdm49

2. Study of IMNN-001 (also known as GEN-1) with NACT for treatment of ovarian cancer (OVATION 2). ClinicalTrials.gov. Updated July 30, 2024. Accessed August 1, 2024. https://clinicaltrials.gov/study/NCT03393884