May 19, 2016
July 2015, Vol. 2, No. 4
Immunotherapy May Prolong Recurrence-Free Survival in Advanced Ovarian Cancer
Society of Gynecologic Oncology
Personalized medicine in the form of immunotherapy holds promise for maintenance treatment of late-stage ovarian cancer, according to a phase 2 study. The personalized vaccine, made from the patient’s own tumor cells, was able to prolong recurrence-free survival compared with standard of care, according to study results presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer 2015.
Among 20 patients who received immunotherapy, the median time to recurrence has not yet been reached, compared with 14.5 months in 11 patients treated with standard of care. The authors say that the majority of patients in the immunotherapy arm have gone “well beyond 14.5 months” without a recurrence. The vaccine was well tolerated.
“This is cutting-edge medicine for ovarian cancer. The immunotherapy may keep the cancer away longer. This preliminary study with promising results may give women with advanced ovarian cancer an option for a maintenance regimen,” stated lead author Jonathan Oh, MD, Texas Oncology PA, Dallas, TX, in an official news release.
Most patients with ovarian cancer are diagnosed with stage III or IV disease, when it is no longer curable. First-line standard of care for advanced ovarian cancer (optimal debulking surgery and chemotherapy) is associated with an 80% recurrence rate. In this phase 2 study, 31 patients with advanced ovarian cancer underwent standard of care and were entered into the trial.
Twenty patients received the FANG vaccine (granulocyte-macrophage colony-stimulating factor/bi-shRNAi furin vector transfected autologous tumor cells) manufactured from their own tumor cells. The vaccine had previously been shown to elicit the desired immune response in a phase 1 trial, Oh explained. The other 11 patients underwent standard of care alone.
Based on the safety of the vaccine, the high rate of T-cell activation in this population that correlates with the immune response, and the marked delay in time to regression, randomization was discontinued, and phase 3 testing of 382 patients is now being planned.
The vaccine was developed by Gradalis, Inc, which sponsored the clinical trial.
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