Phase II Clinical Trials of DCVAC Show Significant Benefit for Patients with Ovarian and Lung Cancer

June 4, 2018
Source: Press Release, Chicago/Prague

Chicago/Prague - 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 at the 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 a Phase II clinic trial (SOV01), DCVAC/OvCa decreased the risk of progression or death in 1st line maintenance treatment of ovarian cancer by almost 60%
  • The SOV02 Phase II clinical trial with DCVAC/OvCa showed prolonged survival in patients with ovarian cancer after 1st recurrence compared to patients treated with chemotherapy only
  • Risk of death reduced by 44% in patients with advanced or metastatic NSCLC treated with DCVAC/LuCa in combination with carboplatin/paclitaxel compared to chemotherapy alone
  • Decision to initiate further clinical trials including a global Phase III with DCVAC/OvCa

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.”

More details about the SOV01 clinical trial results can be found below in the slides from the oral presentation at ASCO.

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.

Abstract with more details on SOV02 clinical trial results is available here.

“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. A copy of the poster can be found below.

About DCVAC:

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 investigate 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.

About SOV01, SOV02 and SLU01 clinical trials:

SOV01 is a randomized, open-label, three-arm multicenter Phase II clinical trial evaluating DCVAC/OvCa in combination with first-line standard chemotherapy in women with newly diagnosed epithelial ovarian cancer following radical debulking surgery.

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.

SLU01 is a randomized, open-label, three-arm, parallel group, multi-center Phase I/II clinical trial evaluating the safety and efficacy of DCVAC/LuCa added to standard first-line chemotherapy with carboplatin and paclitaxel +/- immune enhancers in patients with stage IV non-small cell lung carcinoma (NSCLC).