Ovarian Cancer Update: FDA Grants Peptide Vaccine Orphan Status


A substantial breakthrough has taken place in the area of cancer treatment studies for ovarian cancer. New research demonstrates great potential for the immunotherpay DPX-Survivac, used to treat women with ovarian cancer. In early studies, patients exhibited great immune response to the therapy, coupled with a low-dose cyclophosphamide. In turn, the FDA has bestowed an orphan drug designation in the immunotherapy.

Dr. Marc Mansour, the chief executive officer of Immunovaccine, has released a statement regarding the up-and-coming vaccine for ovarian cancer. Dr. Mansour stated, “Immunotherapy could change the way we treat all cancers in the future and we plan to continue to study of DPX-Survivac for the treatment of ovarian cancer as well as other solid tumor types and blood cancers.” Furthermore, he mentioned that the designation as an orphan drug for the treatment of ovarian cancer emphasizes the fact that DPX-Survivac may be the solution to the problems that the current treatment regimen cannot address.

In the recent 2015 ASCO Annual Meeting, a phase l/lb study presented the initial data that the doctors were able to gather. The study enrolled 40 patients with either stage III or stage IV ovarian cancer. Out of the 40 patients, 39 of them received treatment with the DPX-Survivac immunotherapy, either with or without the low dose cyclophosphamide. It was noted that all 40 patients have undergone platinum-based chemotherapy with favorable responses to the treatment.

The enrolled patients were between 35 to 77 years of age, with a median age of 60. Out of the 40 patients, 79.5% were in the third stage of the disease. Moreover, 59% of patients continued their treatment in the study right after receiving their first-line of therapy.The patients were separated into six group, with each group containing seven participants. The patients were randomly selected so as to avoid any inaccuracy in the results of the study. One group received the vaccine alone while the remaining 5 groups received the immunotherapy with varying doses of the low-dose cyclophosphamide. The vaccine, DPX-Survivac, was injected subcutaneously in the thigh every three weeks.

The main objective of the study was to assess the safety of the immunotherapy, especially in those patients who wre receiving the combination treatment. The secondary objective was to evaluate how the treatment affected the cell-mediated immunity, as well as the clinical regression through radiologic assessment and CA-125. An in-depth explanation of the findings can be found in the journal, OncoImmunology.

Dr. Neil Berinstein, who is also with the Department of Medicine at the University of Toronto, is the lead author of the OncoImmunology paper. He shared a few thoughts about the results of the study, which were officially released last July. “The future of cancer treatment lies in rationally developing combination immunotherapy that can both generate cancer specific T cells and reduce the cancer-mediated immune inhibitory mechanism,” he said. Dr. Berinstein also mentioned that combining complementary immunotherapies will eventually play a critical role in treating other malignancies.