Adding SOTIO’s ovarian cancer immunotherapy DCVAC/OvCa to standard second-line chemotherapy significantly extends the lives of women with advanced ovarian cancer who initially responded to their first-line chemotherapy, a Phase 2 trial shows.
The combination also extended the time patients lived without signs of disease worsening compared with chemotherapy only, the company announced.
The findings were recently presented by David Cibula, MD, PhD, the trial’s lead researcher, in a presentation, “Dendritic cell-based immunotherapy (DCVAC/OvCa) with chemotherapy in patients with platinum-sensitive, relapsed, epithelial ovarian carcinoma: Survival analysis of a phase II, open-label, randomized, multicenter trial (study SOV02),” at the Society of Gynecologic Oncologic 50thAnnual Meeting on Women’s Cancer, March 16–19, in Honolulu, Hawai.
DCVAC/OvCa is an immunotherapy that activates dendritic cells — a kind of immune cells that play critical roles in T-cell activity. Specifically, dendritic cells “tell” T-cells what substances to recognize as harmful, such as cancer proteins.
The treatment requires collecting dendritic cells from a patient and activating them in the lab by exposing them to dead cancer cells, before infusing them back into the patient’s body. Once inside the patient, these dendritic cells will expose T-cells to cancer-specific antigens, optimizing their punch against cancer cells.
The SOV02 Phase 2 trial (NCT02107950) was designed to test DCVAC/OvCa as an add-on therapy for patients with platinum-sensitive epithelial ovarian cancer. The study included 71 women, across 15 clinical sites in Europe, who had achieved a complete response to their first-line platinum-based chemotherapy, lasting more than six months, but eventually relapsing.
For their second-line therapy, patients were randomized to DCVAC/OvCa plus standard chemotherapy — carboplatin and Gemzar (gemcitabine) — or chemotherapy only. Chemotherapy was given for six to 12 cycles. From the second cycle, patients on the DCVAC/OvCa group received five induction doses of the treatment, given three weeks apart, followed by five maintenance doses every six weeks.
The trial’s main goal was to determine if the immunotherapy could extend the time patients lived without their disease progressing, which it did. Patients given DCVAC/OvCa lived a median of 11.3 months without disease worsening, compared with 9.5 months for chemotherapy.
Overall survival was a main secondary goal, which was also met, the researchers reported. Patients given DCVAC/OvCa lived a median of 13.4 months longer than those on chemotherapy — 35.5 months versus 22.1 months — representing a 62% reduction in the risk of death.
After two years, 73% of patients in the DCVAC/OvCa group were alive, compared with 41% in the chemotherapy group.
Treatment with DCVAC/OvCa was well tolerated without any patients stopping treatment due to side effects.
“Results from final data analysis of SOV02 clinical trial show that patients with recurrent ovarian cancer treated with DCVAC/OvCa are living significantly longer than patients in the control group. This outcome stands out very positively in this highly competitive clinical development landscape,” David Cibula, MD, PhD, at the General University Hospital, Prague, Czech Republic, said in a press release.
SOTIO is also evaluating its immunotherapy in combination with chemotherapy in newly diagnosed ovarian cancer patients — SOV01 Phase 2 trial (NCT02107937) — and in women who responded to first-line platinum-based chemotherapy but eventually relapsed – SOV06 trial (NCT03657966).
“We are very happy that the results of SOV02 study in the second line treatment of ovarian cancer confirm the promising data of SOV01 trial in the first line, reported at ASCO 2018,” said Radek Spisek, MD, PhD, chief executive officer of SOTIO.
Based on these promising results, SOTIO is planning a Phase 3 trial for DCVAC/OvCa.
“In cooperation with ENGOT (The European Network for Gynaecological Oncological Trial), we are now setting up the design of the pivotal trial that will build on the results of the Phase II program. With the development of DCVAC/OvCa and the latest result we are addressing the medical need in this harmful disease,” added Spisek.