“This is cutting edge medicine for ovarian cancer,” said Jonathan Oh, MD, a gynecologic oncologist at Texas Oncology, P.A., in Dallas. Dr. Oh presented the results of a preliminary study on the vaccine at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer on March 28 in Chicago.
The phase II study included 31 women with stage III or IV ovarian cancer. Twenty received immunotherapy and 11 did not. The cancer in those who did not receive the immunotherapy returned in a median of 14.5 months. Those who did receive the immunotherapy have not reached the median time to recurrence and the majority is well beyond 14.5 months.
In 2015, there will be an estimated 21,290 women will be diagnosed with ovarian cancer and 14,180 will die, according to the American Cancer Society. Because symptoms are often not noticeable in the early stages, most women are diagnosed in later stages when treatment is less effective, and prognosis — chances of survival — are worse.
The National Cancer Institute states that about 80 percent of women treated for ovarian cancer relapse after their first treatment.
“This immunotherapy may keep the cancer away longer,” Dr. Oh said.
The immunotherapy is called “bifunctional” because it works by targeting a biochemical pathway in cancer cells and by helping to stimulate the patient’s immune response to fight cancer.
During the initial surgery to remove the tumor, sample cells are taken to develop the personalized immunotherapy. After the initial surgery followed by standard of care chemotherapy, women received either one injection per month for anywhere between four and 12 months or were randomized to standard of care.
“This was a preliminary study with promising results that may give women with advanced ovarian cancer an option for a maintenance regimen,” Dr. Oh said. “Additionally, the vaccine is very well tolerated.”
“The results from this clinical trial suggest that using a patient’s immune system to fight advanced ovarian cancer may be a promising avenue to improve outcomes in what has continued to be the most aggressive gynecologic cancer,” said Krishnansu S. Tewari, MD, a gynecologic oncologist, professor and director of research at the University of California, Irvine Medical Center, Orange, CA.
The immunotherapy was developed by Gradalis, Inc., which sponsored the clinical trial. Dr. Oh is a shareholder in Gradalis. Dr. Tewari was not involved in the trial and has no relationship with Gradalis.