Immunotherapy extends survival in advanced ovarian cancer: Data
IMNN-001 may drive outcomes that can 'make a difference' for women
When added to standard care, Imunon’s immunotherapy candidate IMNN-001 extended the average survival for people with newly diagnosed advanced ovarian cancer by more than a year, according to new clinical trial data.
These results will be shared in an oral presentation next week at the annual meeting of the American Society of Clinical Oncology, and will also be simultaneously published in the journal Gynecologic Oncology, per an Imunon press release.
According to Stacy Lindborg, PhD, the company’s president and CEO, data from the Phase 2 OVATION 2 trial (NCT03393884) have consistently suggested that IMNN-001 “may drive positive outcomes that can truly make a difference in the lives of women with ovarian cancer, even for those with advanced and very difficult to treat stages of disease.”
Imunon called the new data “unprecedented” in the press release.
Added Lindborg: “We are very encouraged by these remarkable results and the fact that they are being presented in two of the most prestigious platforms in oncology research.”
Based on the positive data, Imunon reported that it has set the first two study sites for a Phase 3 trial — dubbed OVATION-3 (NCT06915025) — testing the treatment. The study will include an estimated 500 adults with newly diagnosed advanced epithelial ovarian cancer who are eligible to receive standard chemotherapy.
“We look forward to advancing our Phase 3 pivotal trial of IMNN-001 as quickly as possible in efforts to bring this novel therapy to the many women in desperate need of new treatment options,” Lindborg said.
Patients on IMNN-001 had median survival of 46 months
In about 70% of cases, epithelial ovarian cancer, the most common type of ovarian cancer, is diagnosed in advanced stages when the cancer has already spread within the abdominal cavity or elsewhere. That makes it extremely difficult to treat.
Standard treatment for this form of gynecological cancer generally involves chemotherapy before and after surgery to remove as much of the cancer as possible. This is called a neoadjuvant/adjuvant chemotherapy (N/ACT) regimen. Still, disease recurrence rates for advanced ovarian cancer are high, and the prognosis is poor.
IMNN-001 is a DNA-based immunotherapy designed to enter cells and enable production of IL-12, an immune signaling protein with a potent ability to turn on cancer-killing immune responses.
It’s injected directly into the abdominal cavity, enabling targeted delivery to the tumor site and potentially avoiding systemic side effects that can come with immunotherapies, per the company.
In OVATION 2, 112 people with newly diagnosed advanced epithelial ovarian cancer were randomly assigned to receive IMNN-001 injected once weekly (up to 17 doses) in addition to N/ACT, or N/ACT alone. The study’s participants were followed for a median of about 2.5 years.
The results showed median survival among those on IMNN-001 was 46 months, or nearly four years, compared with 33 months, or slightly less than three years, for those who received standard care.
This increased survival benefit of more than one year amounted to about a 30% lower risk of death with IMNN-001, Imunon reported.
Treatment with IMNN-001 also was associated with a median three-month increase in progression-free survival (PFS), or the time spent alive without disease progression, relative to the standard care group (14.9 months vs. 11.9 months). This amounts to a more than 20% risk reduction.
First immunotherapy with favorable safety profile for ovarian cancer
Study chair Premal H. Thaker, MD, of Washington University School of Medicine, noted an increase in survival by six months is usually considered clinically meaningful.
“The data … indicate that IMNN-001 could extend the lives of women … newly diagnosed with advanced ovarian cancer by one year or longer, representing a potentially historic advance in standard of care,” said Thaker, who will also chair OVATION 3.
Particular treatment benefits were observed in patients whose standard maintenance treatment included PARP inhibitors, a type of targeted therapy used for certain people with ovarian and other forms of cancer.
The data … indicate that IMNN-001 could extend the lives of women … newly diagnosed with advanced ovarian cancer by one year or longer, representing a potentially historic advance in standard of care.
After more than five years, the median survival for IMNN-001-treated participants in this subgroup hadn’t been reached, meaning not enough patients had died to calculate a value. This group also achieved a nearly one-year increase in PFS with IMNN-001 versus standard care.
A survival benefit was also observed for women positive for homologous recombination deficiency (HRD), a characteristic of cancer cells that makes them sensitive to treatments such as PARP inhibitors. This includes people with BRCA1 and BRCA2 gene mutations.
IMNN-001 was well tolerated, with the most common side effects being abdominal pain, nausea, and vomiting, according to the company.
The findings are overall aligned with previously reported positive results from OVATION 2, per Imunon.
Thaker overall finds the data to be “powerful and highly encouraging,” noting IMNN-001 is the first immunotherapy to have a favorable safety profile and to demonstrate such a survival benefit when used as part of first-line treatment regimens.
In OVATION 3, the participants — including a subgroup who are HRD-positive — will be randomly assigned to receive standard care, with or without IMNN-001. The main goal will be to assess overall survival. Secondary endpoints include surgical response score, chemotherapy response score, clinical response, and time to second-line treatment.
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