Sotio on track for 2nd Phase III trial
After positive preliminary results of Sotio's SOV02 trial in ovarian cancer had been presented last year, the final analysis confirmed the survival benefits. The Czech biotech company now plans to initiate a global Phase III study with its autologous cell-based immunotherapy also in this indication.
In Sotio’s randomised, open label SOV02 clinical trial, patients with recurrent platinum-sensitive epithelial ovarian cancer received DCVAC/OvCa in combination with platinum-based chemotherapy. Compared to patients receiving standard chemotherapy (carboplatin and gemcitabine), DCVAC/OvCa decreased the risk of death by 62%: The combination of chemotherapy and immunotherapy corresponded with 73% survival at two years, compared to 41% survival when chemotherapy was used alone (p-value of 0.0032). Progression Free Survival (PFS) increased from 9.5 to 11.3 months. This outcome stands out very positively in this highly competitive clinical development landscape, said David Cibula, MD, PhD, General University Hospital Prague (Czech Republic) and principal investigator of SOV02 study. The data was presented in mid-March at the the Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer in Honolulu (US).
The results of the SOV02 study in the second line treatment of ovarian cancer confirm the promising data of the SOV01 trial in the first line, also reported at ASCO 2018. In the 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%. PFS increased from 18.6 to 24.3 months. In addition, the side effect profile did not lead to any treatment discontinuation in both trails.
The pivotal trial building on the results of the Phase II programme will be set up in cooperation with the European Network for Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology founded in 2007, Sotio stated.
Sotio a.s. belongs to the richest Czech, PPF Group’s Petr Kellner, who finances already Sotio’s first Phase III programme: The global multi-center Phase III clinical trial in prostate cancer called the VIABLE was launched in 2014. Enrolling a total of 1,170 prostate cancer patients, the study with the cell therapy DCVAC/PCa will be completed in summer 2020.
All DCVAC products are made from the cells of the patients immune system. Manufacturing is complex as monocytes are harvested and then differentiated into dendritic cells. During differentiation the dendritic cells are exposed to cancer cells killed by a method developed at Sotio. The patients own dendritic cells engulf the dying tumour cells and present tumour antigens on their surface. After administration of the antigen-presenting dendritic cells back into the patient, other immune system cells of the patient are encountered and an immune response to the tumor cells is initiated. So far, Sotio is centralising the production process in Prague for patients in Europe and the US. A Chinese facility dedicated for Chinese customers has been opened in 2014. Stored in liquid nitrogen, the therapy is then shipped to the treatment site.
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