June 2, 2019
Source: Press Release, Chicago/Prague
- DCVAC/LuCa decreased the risk of death in patients with stage IV NSCLC by 46%
- Median overall survival (OS) reached 15.5 months in the treatment arm compared to 11.8 months in the control arm
- Median Progression Free Survival (PFS) prolonged by 1.1 months
- Final results of OS and PFS are statistically significant
- SOTIO considers initiation of Phase II/III clinical trials with DCVAC/LuCa
SOTIO, a biotechnology company owned by the PPF Group, presented new statistically and clinically significant results from its Phase I/II clinical trial evaluating DCVAC/LuCa, an active cellular immunotherapy product, in patients with stage IV non-small cell lung cancer. The final analysis of the data confirmed the promising clinical efficacy of DCVAC/LuCa. SLU01 clinical trial results were presented by the principal investigator Libor Havel, MD, from Thomayer University Hospital in Prague (Czech Republic) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago today.
SOTIO evaluated its proprietary product DCVAC/LuCa in an open label, randomized, multicenter Phase I/II trial in combination with carboplatin/paclitaxel in patients with advanced or metastatic non-small cell lung cancer. Patients that received DCVAC in combination with chemotherapy have a 46% lower risk of dying compared to those who received chemotherapy alone. Furthermore, the 3.7-month longer survival with the DCVAC/chemo combination is statistically and clinically significant. Treatment was very well tolerated and there were no serious adverse events solely related to DCVAC/LuCa.
“The final results of the SLU01 study confirmed our original hypothesis that adding DCVAC to the standard of care chemotherapy could prolong both overall survival and progression-free survival,” commented Libor Havel, MD, Thomayer University Hospital in Prague (Czech Republic), principal investigator of SLU01 study. “I have seen that most of my patients receiving DCVAC have significantly improved their quality of life and I hope this can be confirmed in further clinical trials as well.”
Radek Spisek, MD, PhD, Chief Executive Officer of SOTIO commented: “Lung cancer is one of the most insidious diseases with limited treatment options. We are encouraged by the results of the trial and will discuss the further clinical development of DCVAC/LuCa with our shareholders and key opinion leaders, with the goal being to provide patients with an effective treatment option in the future. Results of SLU01 follow the very promising results of DCVAC in patients with ovarian cancer, reported at ASCO 2018 and SGO 2019.”
The abstract with final SLU01 clinical trial data is available online here: Abstract 9039. A copy of the poster is available below this text.
SOTIO attends ASCO 2019 (May 31 to June 4, 2019) with its own exhibition booth (#5147) and presents its clinical development pipeline to the expert community.
About SLU01 clinical trial:
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).
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/LuCa for patients with lung cancer, DCVAC/OvCa for patients with ovarian cancer and DCVAC/PCa for patients with prostate cancer.
The company is currently testing the safety and efficacy of investigational medicinal treatment DCVAC through multiple Phase I to Phase III clinical trials.