A combination of chemotherapy and immune-modulating therapies administered directly into the abdomen may help control ovarian cancer that has spread within the abdominal cavity, data from a small clinical trial show.
Results from the study were discussed earlier this month at the 40th Annual SITC Meeting. The presentation was titled, “A phase II trial of combination locoregional chemoimmunotherapy in recurrent platinum-sensitive ovarian cancer triggers a T lymphotactic response correlating with clinical outcomes.”
Ovarian cancer is a type of gynecological cancer that occurs due to the growth of cells in or near the ovaries. In many people, the cancer spreads within the abdomen — a condition called peritoneal disease — which can make it harder to treat.
How the study tested the new therapy
In this Phase 2 clinical trial (NCT03734692), researchers tested a treatment approach called locoregional chemoimmunotherapy. This strategy combines chemotherapy — drugs that kill cancer cells — with immunotherapy, which helps the immune system attack cancer. Instead of all these therapies being given systemically throughout the body, some are administered locoregionally — that is, directly into the part of the body where the cancer is growing.
The study tested three medications. One, pembrolizumab, was administered into the bloodstream. Pembrolizumab is an immunotherapy sold by Merck under the brand name Keytruda for several types of cancer, though it’s not approved for ovarian cancer specifically.
The other two therapies, cisplatin and Ampligen (rintatolimod), were injected into the abdomen (a method known as intraperitoneal delivery). Cisplatin is a widely approved chemotherapy, while Ampligen is an experimental agent designed to increase the efficacy of immunotherapies by promoting the activity of cancer-killing immune cells.
The study enrolled 27 people with ovarian cancer and peritoneal disease whose tumors were sensitive to platinum-based chemotherapies like cisplatin. Participants could receive up to six treatment cycles at three-week intervals.
The trial was led by scientists at the University of Pittsburgh. It was funded in part by Merck and by Aim Immunotech, the developer of Ampligen.
The study’s main goal was to assess how many participants had an objective response, meaning their cancer decreased in size following treatment. Among 24 patients who could be evaluated, 50% had an objective response. Specifically, five had a complete response, where the cancer disappeared, and seven had a partial response, with tumors that shrank but did not go away completely.
Putting the results in perspective
To put the findings in context, according to a press release from Aim Immunotech, prior studies using Keytruda alone in ovarian cancer showed objective response rates less than 10%. This suggests adding Ampligen could improve the effectiveness of immunotherapies, according to Robert Edwards, MD, co-author of the study at the University of Pittsburgh School of Medicine.
“Ampligen’s demonstrated ability to enhance the effectiveness of traditional cancer treatments could make it a difference maker that dramatically improves tumor immune responses and significantly prolongs the lives of people who have otherwise few effective options for prolonged remission and even possible cure,” Edwards said.
Data from the Phase 2 study indicated patients who responded to the combination treatment tended to have higher counts of cancer-killing immune cells in their tumors. The therapy was overall well tolerated. Common side effects included fatigue, anemia, abdominal pain, high blood pressure, nausea, vomiting, and loss of appetite.
Ampligen is approved in Argentina for the treatment of severe chronic fatigue syndrome.
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