IMNN-001 May Extend Survival in Advanced Gynecologic Cancers

Patients with gynecologic cancer who received the novel IMNN-001 treatment had a 15.7-month increase in median survival, research showed.

Patients with advanced gynecologic cancer tended to live nearly one year longer when they added the novel drug, IMNN-001, to standard neoadjuvant (presurgical) chemotherapy, compared to those who received presurgical chemotherapy alone according to results from the phase 2 OVATION 2 clinical trial.

Overall and Progression-Free Survival Results in Advanced Gynecologic

Trial results, announced in a press release by Imunon, the manufacturer of IMNN-001, showed that the group that received the new drug had a median increase in overall survival of 11.1 months compared with those who did not receive IMNN-001. Overall survival is a statistic used to describe the time from treatment until death of any cause. These data represent a 35% improvement in survival.

Further, among the 90% of patients who received 20% or more of the specified treatments, the overall survival benefit was even more pronounced. Those in the IMNN-001 group had a 15.7-month increase in median survival. That’s a 56% improvement, according to the press release.

For patients whose ovarian cancer was previously treated with a PARP inhibitor, the median overall survival was not yet reached in the IMNN-001 group. This means that not enough patients have died for the researchers to calculate an average time to death. Conversely, the overall survival in the group of patients who only received presurgical chemotherapy was 37.1 months.

The OVATION 2 trial also showed that IMNN-001 may improve progression-free survival, which is the time from treatment until disease worsening or death.

Specifically, patients who received the novel drug alongside standard neoadjuvant chemotherapy had a median three-month improvement in progression-free survival compared to those who received presurgical chemotherapy alone. This correlates to a 27% improvement in the delaying of disease progression.

“Typically, an increase in survival of six months is considered to be clinically meaningful and extending survival from 29 months with standard-of-care treatment to 40 months with the addition of IMNN-001 is compelling. Importantly, the extension of survival among IMNN-001 patients also exposed to the new standard that includes PARP inhibitors is even greater. If confirmed in a phase 3 clinical trial, IMNN-001 could reset the standard of care for women with ovarian cancer,” Dr. Premal H. Thaker, interim chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and the OVATION 2 study chair, said in the release.

READ MORE: Elahere Gets Full FDA Approval for Pretreated Gynecologic Cancer

About the OVATION 2 Trial, Next Steps

OVATION was a phase 2 trial that evaluated the dosing, safety, efficacy and biological activity of IMNN-001 plus chemotherapy (paclitaxel and carboplatin) in patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

Patients in the trial then underwent surgery to remove the cancer, followed by adjuvant (postsurgical) chemotherapy.

The trial included 112 patients — half were randomly assigned to receive IMNN-001 with chemotherapy before surgery, while the other half received only chemotherapy before surgery.

Researchers are now hoping to test the IMNN-001—chemotherapy combination in a larger phase 3 trial.

“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,” Stacy Lindborg, president and CEO of Imunon, said in the company-issued press release.

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