Ultimovacs has announced that the first patient has been randomized in the LUNGVAC study.
The study in non-small cell lung cancer (NSCLC) is the fifth Phase II clinical trial in which the universal cancer vaccine, UV1, is being investigated in combination with checkpoint inhibitors.
The LUNGVAC study is designed to assess the impact of UV1 in combination with standard-of-care immunotherapy, the anti-PD1 checkpoint inhibitor pembrolizumab. Topline data read-out from LUNGVAC is anticipated by the end of 2024. The guiding will be reviewed in the Company’s Q4 2022 reporting.
“LUNGVAC addresses one of the world’s largest cancer indications, and we have designed the trial to test if UV1 in combination with pembrolizumab can improve the treatment of patients with unmet needs,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “LUNGVAC’s focus within Norway provides efficient access to the country’s well-organized lung cancer networks as well as a single national portal for clinical trial registration.”
LUNGVAC is 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 primary endpoint of the trial will be progression-free survival. Secondary endpoints will include overall survival, response rate, duration of response and safety. The principal investigator for LUNGVAC is Professor Odd Terje Brustugun, a leading oncologist in the Nordic region with active involvement in multiple international lung cancer clinical trials.
“Our motivation for starting clinical trials is to contribute to the further improvement in treatment options for patients with non-small cell lung cancer,” added professor Odd Terje Brustugun the principal investigator of the study. “The evaluation of UV1 and pembrolizumab is an important next step in changing the standard of care for patients with non-small cell lung cancer. We look forward to working with Ultimovacs to reach our mutual goal.”