Ultimovacs has announced that cemiplimab (Libtayo) will be used as the PD-1 checkpoint inhibitor in combination with UV1 in the Phase II randomized LUNGVAC trial rather than pembrolizumab (Keytruda).
The move, which will be implemented January 1, 2023, follows the decision by the Norwegian Health Authorities of reimbursement of cemiplimab for monotherapy or first-line treatment of advanced non-small-cell lung cancer (NSCLC) in Norway. The protocol for LUNGVAC as submitted and approved was designed to be flexible and encompassed the use of a range of different PD-1 checkpoint inhibitors. No regulatory interaction is needed based on change of drug, and enrollment is ongoing without delay.
LUNGVAC is a multi-center, randomized, open-label trial assessing the safety and efficacy of UV1 in combination with PD-1 checkpoint inhibitor versus PD-1 checkpoint inhibitor alone. The study will enroll patients with advanced or metastatic non-small cell lung cancer (NSCLC) at approximately all lung cancer centers in Norway. 138 patients will be recruited for treatment with cemiplimab as standard-of care. The patients already enrolled in the study will continue the treatment with pembrolizumab. The primary endpoint of the phase II trial will be progression-free survival. 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.
LUNGVAC is the fifth Phase II clinical trial in which the universal cancer vaccine, UV1, is being investigated in combination with checkpoint inhibitors. The timeline for topline readout of LUNGVAC will be reviewed in Ultimovacs’ Q4 2022 reporting.
Photo: Ultimovacs R&D