4 June 2019 - - Czech biotechnology company Sotio, which is 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 company said.
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 annual meeting in Chicago .
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.
SLU01 is a randomised, 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).