SOTIO, a biotechnology company owned by the PPF Group, presented results from its Phase II clinical trials evaluating DCVAC, an active cellular immunotherapy product, in patients with ovarian and lung cancer at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting today. The results were statistically and clinically significant and showed that compared to patients who did not receive DCVAC, application of DCVAC/OvCa in patients with ovarian cancer and DCVAC/LuCa in patients with lung cancer decreased the risk of progression or death significantly.
In the randomized, open label SOV01 clinical trial, patients with ovarian cancer received DCVAC/OvCa as a maintenance therapy after initial surgery and completion of chemotherapy. Compared to patients who did not receive DCVAC, it decreased the risk of progression or death by almost 60%. Progression Free Survival (PFS) increased from 18.6 to 24.3 months. In addition, the side effects related solely to DCVAC/OvCa were not serious and did not lead to any treatment discontinuation.
“In the early treatment phase, prolonged time to disease progression has been shown to benefit the patients and this was supported by a significant trend in increased overall survival of patients with DCVAC,” commented Lukas Rob, MD, PhD, University Hospital Kralovske Vinohrady (Prague, Czech Republic), principal investigator of SOV01 study. “There is no approved treatment in this particular patient population that has shown such a magnitude of clinical benefits.”
In the randomized, open label SOV02 clinical trial with DCVAC/OvCa, patients with first recurrence of ovarian cancer received DCVAC in combination with platinum-based chemotherapy.
“The data collection is still ongoing, but results from primary analysis showed that those patients are living longer than patients in the control group. If the trend is consistent until study closure, we might see patients who received DCVAC plus chemo living at least a year longer compared to patients who received chemotherapy only,” said David Cibula, MD, PhD, General University Hospital (Prague, Czech Republic), Past-President of European Society of Gynaecological Oncology (ESGO), principal investigator of SOV02 study who also participates in SOV01 study.
“Based on the promising results from our Phase II clinical trials with DCVAC/OvCa, we decided to initiate further clinical trials including a global Phase III,” added Radek Spisek, MD, PhD, Chief Executive Officer of SOTIO.
SOTIO also evaluated DCVAC/LuCa combined with carboplatin/paclitaxel in patients with advanced or metastatic non-small cell lung cancer. Patients that received DCVAC have an almost 44% lower risk of dying compared to those who received chemotherapy only. Furthermore, the 3.6-month longer survival with DCVAC is statistically and clinically significant.