Chicago, IL—Immunotherapy holds promise for the maintenance treatment of late-stage ovarian cancer, according to results of a phase 2 clinical trial. The vaccine, made from the patient’s own tumor cells, was able to prolong recurrence-free survival compared with standard of care.
Among 20 patients who received immunotherapy, the median time to recurrence has not yet been reached, whereas among 11 patients who received standard of care, the median time to recurrence was 14.5 months. The investigators 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 investigator Jonathan C. Oh, MD, of Texas Oncology, P.A., Dallas, in an official news release. Dr Oh presented the study results at the 2015 Society of Gynecologic Oncology annual meeting.
Most patients with ovarian cancer are diagnosed with stage III or IV ovarian cancer, 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 trial, 31 patients with advanced ovarian cancer underwent standard of care and were entered into the trial.
Of these patients, 20 received the FANG vaccine (granulocyte-macrophage colony-stimulating factor/bi-shRNAi furin vector-transfected autologous tumor cells), which is manufactured from their own tumor cells. The vaccine was previously shown to elicit the desired immune response in a phase 1 trial, Dr Oh said. The other 11 patients received 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, the phase 2 trial was discontinued and phase 3 testing of 382 patients is now being pursued.
