The Phase 3 trial evaluating the immunotherapy DCVAC/PCa in men with metastatic castration-resistant prostate cancer (mCRPC), has completed patient enrollment, according to trial sponsor, SOTIO.
The treatment is being evaluated as an add-on to standard of care chemotherapy – Taxotere (docetaxel) – for patients who have not received prior chemotherapy.
“The completion of the patient enrolment to the VIABLE study is an important milestone. It is a major step towards registration of our active cellular immunotherapy and making it available for routine clinical use,” Ladislav Bartonicek, CEO of SOTIO, said in a press release. “We are grateful to all our medical partners, the patients and their families for their ongoing support of this study. After finalization of treatment and follow-up period we expect to finalize the primary analysis of the data in 2020.”
SOTIO has been developing a new immunotherapy strategy based on the activation of a specific subset of immune cells, called dendritic cells, to boost anti-tumor immune responses.
Dendritic cells are responsible for pointing out to T-cells elements that should recognized as harmful, such as cancer proteins. SOTIO’s strategy is to take advantage of the natural activity of dendritic cells and expose them to cancer-specific antigens. This process optimizes the activation of T-cells toward cancer cells.
SOTIO’s approach consists of collecting a patient’s own dendritic cells, which are then activated in the company’s laboratories by exposure to dead cancer cells.
In addition to DCVAC/PCa, SOTIO is developing two other dendritic cell-based active cellular (DCVAC) immunotherapy products, including DCVAC/OvCa for ovarian cancer, and DCVAC/LuCa for lung cancer.
The VIABLE study (NCT02111577/ is a global, double-blind, placebo-controlled trial. The study is being conducted in about 200 clinical sites across Europe and the United States. Since its launch in 2014, 1,183 patients have been randomized to receive DCVAC/PCa, or placebo, plus chemotherapy.
The trial’s main goal is to determine if the add-on treatment increases patients’ overall survival. But researchers also will assess if DCVAC/PCa delays disease progression, assessed by radiographic imaging, time to PSA progression, or the time until patients experience skeletal related events — bone fractures, spinal cord compression, orthopedic surgery, and palliative radiation to the bone, all caused by bone metastasis.
“This pivotal clinical trial is building on many years of scientific research at Charles University and University Hospital in Motol in Prague and intensive development efforts of SOTIO,” said Radek Spisek, PhD, chief scientific officer of SOTIO.
“Completing the enrollment underlines the significant progress SOTIO has made in the assessment of the innovative, dendritic cell-based active cellular [DCVAC] immunotherapy for late stage prostate cancer and other cancer indications. We believe that adding DCVAC to standard chemotherapy can prolong patients’ lives and slow down disease progression” Spisek said.