March 19, 2019
Source: Press Release, Honolulu/Prague
- DCVAC/OvCa decreased the risk of death in second line treatment of ovarian cancer by 62%.
- Overall survival (OS) increased significantly by 13.4 months. Median Progression Free Survival (mPFS) increased by 1.8 months.
- SOTIO plans to initiate a global Phase III study with DCVAC/OvCa.
SOTIO, a biotechnology company owned by the PPF Group, presented results from SOV02, its Phase II clinical trial evaluating DCVAC/OvCa, an active cellular immunotherapy product, in patients with recurrent ovarian cancer at 2019 SGO’s 50th Annual Meeting on Women's Cancer today. Final analysis of SOV02 shows that DCVAC/OvCa decreased the risk of death significantly compared to patients who did not receive DCVAC/OvCa. Clinical trial results were presented during today’s SGO 2019 Plenary Session by SOV02 principal investigator David Cibula, MD, PhD from General University Hospital in Prague (Czech Republic).
In the randomized, open label SOV02 clinical trial, patients with recurrent ovarian cancer received DCVAC/OvCa in combination with platinum-based chemotherapy. Compared to patients who did not receive DCVAC, it 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. Overall survival results are statistically significant with a p-value of 0.0032. Progression Free Survival (PFS) increased from 9.5 to 11.3 months. Treatment with DCVAC/OvCa was very well tolerated and did not lead to any treatment discontinuation.
“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,” 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.
Radek Spisek, MD, PhD, Chief Executive Officer of SOTIO commented: “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. In cooperation with ENGOT, 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.”
More information and details about the SOV02 clinical trial results can be found in the slides from the oral presentation at SGO 2019 posted below.
About SOV02 clinical trial:
SOV02 is a randomized, open-label, parallel-group, multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to standard chemotherapy (carboplatin and gemcitabine) in women with first relapse of platinum-sensitive epithelial ovarian cancer.
The SOTIO DCVAC product candidates are active cellular immunotherapy treatments which are produced individually for each patient using the patient’s own dendritic cells (which form part of the immune system) to induce an immune reaction against tumor antigens. SOTIO is developing three product candidates using the DCVAC platform to affect multiple different cancers in various stages of the disease - DCVAC/OvCa for patients with ovarian cancer, DCVAC/PCa for patients with prostate cancer and DCVAC/LuCa for patients with lung cancer.
The company is currently testing the safety and efficacy of investigational medicinal treatment DCVAC through multiple Phase I to Phase III clinical trials.
The Society of Gynecologic Oncology (SGO) is the premier medical specialty society for health care professionals trained in the comprehensive management of gynecologic cancers. SGO contributes to the advancement of women’s cancer care by encouraging research, providing education, raising standard of practice, advocating for patients and members and collaborating with international organizations. SGO has around 2000 members representing entire gynecologic oncology team on international level.
SOTIO is an international biotechnology company leading the efforts of PPF Group to build a diverse biotechnology portfolio through its own research & development, collaborations, in-licensing, investments, mergers and acquisitions. The company is developing new medical therapies, focusing on the treatment of cancer and autoimmune diseases. The most advanced project is the SOTIO proprietary platform of active cellular immunotherapy (ACI) based on dendritic cells. SOTIO is conducting multiple Phase I to Phase III clinical trials verifying the safety and efficacy of its DCVAC products. SOTIO is also collaborating with NBE Therapeutics on the development of novel antibody-drug conjugate products (ADC), with Cytune Pharma on developing novel IL15-based immunotherapies for the treatment of cancer and with LDC and the Max Planck Society on an oncology program addressing a novel target in tumor metabolism. SOTIO has facilities in Europe, the United States, China and Russia. SOTIO is a registered trademark of SOTIO a.s. in selected countries.