Sotio, a biotechnology company owned by the Czech PPF Group, presented results from SOV02, a phase II clinical trial evaluating DCVAC/OvCa dendritic cell-based cancer vaccine in patients with relapsing platinum-sensitive ovarian cancer, during the 50th Annual Meeting of the Society of Gynecologic Oncology (SGO) in March 2019. Adding DCVAC/OvCa to platinum-based chemotherapy improved overall survival (OS) at 2 years by 62% over chemotherapy alone.
Ufuk Ezer, MSc, Oncology and Hematology Analyst at GlobalData, a leading data and analytics company, offers his view on the on the results from SOV02 trial:
“Sotio’s SOV02 trial results are important because DCVAC/OvCa reached statistical significance in reducing risk of death by extending the median OS from 22.1 months to 35.5 months. DCVAC/OvCa also appears to be well tolerated as there were almost no serious adverse events associated with the treatment and there was no discontinuation amongst 71 patients.
“DCVAC/OvCa aims to stimulate the immune system and to form adaptive defenses against cancer. This can potentially translate to a more durable response to treatment. DCVAC/OvCa can be made to order from cells of a patient’s own immune system, which makes the treatment highly personalized.
“One of the drawbacks to DCVAC/OvCa, which is also an innate problem with vaccines, is that the effectiveness of the vaccine depends on various physiological factors, including the patient’s immune system. Advanced cancer patients with weak immune systems are less likely to produce a robust response to treatment and DCVAC is being trialed in combinations to boost the likelihood of success.
“Sotio also announced that the company is in the process of designing the pivotal phase III trials for DCVAC/OvCa in cooperation with The European Network for Gynaecological Oncological Trial groups (ENGOT), which will evaluate the combination use of the vaccine with chemotherapy, Avastin and poly-ADP ribose polymerase (PARP) inhibitors, and is aimed to start by the second half of 2019.
“Available treatments for ovarian cancer have been centered on chemotherapies for decades and in recent years targeted therapies, such as immunotherapies and PARP inhibitors, are changing the treatment landscape. Despite improved survival rates, most patients still relapse and their cancer gains resistance to available treatments.
“Due to resistance mechanisms in ovarian cancer, immunotherapies haven’t been able to reproduce successes seen in other types of cancer.
“There is a significant unmet need for the treatment of recurrent ovarian cancer, and cell-based immunotherapies, such as DCVAC/OvCa, can complement existing therapies and improve treatment outcomes in ovarian cancer.”