Combination extends survival in advanced ovarian cancer
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The addition of an investigational immunotherapy to chemotherapy prolonged survival for women with advanced ovarian cancer, according to a topline data announcement.
IMNN-001 (Imunon Inc.) is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, according to a press release issued by its manufacturer. The delivery system allows for cell transfection followed by persistent secretion of IL-12, the release stated.
The randomized phase 2 OVATION 2 study included women with newly diagnosed advanced ovarian cancer.
Women in the investigational group received IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy, plus interval debulking or cytoreductive surgery. Women in the control group received neoadjuvant chemotherapy and surgery.
PFS served as the primary endpoint. Researchers also assessed OS, objective response rate, chemotherapy response score and surgical response.
Data released by Imunon showed a 3-month PFS improvement (HR = 0.79) and an 11-month OS improvement (median, 40 months vs. 29 months; HR = 0.74) in the IMNN-001 group.
Ninety percent of women in the trial received at least 20% of protocol-specified treatments in their assigned group. Among these women, researchers reported a 15.7-month improvement in median OS in the IMNN-001 group (HR = 0.64).
Researchers observed a particularly strong OS benefit with the IMNN-001 regimen among women treated with a poly ADP-ribose polymerase (PARP) inhibitor (median, not reached vs. 37.1 months; HR = 0.41).
“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,” Stacy Lindborg, PhD, president and CEO of Imunon, said in the release. “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.”
Imunon intends to begin a registrational phase 3 study in early 2025, according to the press release.
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