Ultimovacs’s universal cancer vaccine, UV1, will be investigated in a new Phase II clinical trial in combination with pembrolizumab in non-small cell lung cancer (NSCLC).
The first patient is expected to be treated in H1 2022, with data read-out from the trial, LUNGVAC, anticipated by the end of 2024.
“We see this new trial as a significant opportunity for Ultimovacs to make a difference to the lives of thousands of patients with advanced lung cancer,” says Carlos de Sousa, CEO of Ultimovacs. “Our extensive Phase II program is aimed at building a substantial evidence base that UV1 in combination with checkpoint inhibitors can stimulate the immune response resulting in enhanced treatment outcomes.”
The LUNGVAC trial
The LUNGVAC trial will be a multi-center, randomized, open-label trial assessing the safety and efficacy of UV1 in combination with pembrolizumab versus pembrolizumab alone in NSCLC patients with advanced or metastatic disease. The trial will treat patients with tumors classified within the adenomcarcinoma or squamous subgroups of NSCLC, where at least half of the tumor cells express the PD-L1 antigen and who have not previously received pembrolizumab treatment. These subgroups represent approximately 1/3 of all advanced and metastatic NSCLC patients. The primary endpoint of the trial will be progression-free survival. Secondary end-points will include response rate and overall survival.
Professor Odd Terje Brustugun will be the principal investigator for the trial, which will be sponsored by Drammen Hospital, a leading oncology research center in Norway. The trial will enroll approximately 138 patients and will be conducted at 8-10 clinical centers in Norway.
UV1 is currently being investigated in four other Phase II trials
UV1 is currently being investigated in four other Phase II trials in advanced malignant melanoma, ovarian cancer, head and neck squamous cell carcinoma and malignant pleural mesothelioma. In total, the five Phase II trials will enroll more than 650 patients at close to 100 hospitals in around 15 countries. The combination of UV1 and pembrolizumab was recently granted a Fast Track designation by the U.S. FDA in the treatment of advanced malignant melanoma.