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Oslo, October 25, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced that the results from Phase II FOCUS trial (NCT05075122) have been published online on the preprint platform medRxiv.
As previously reported, topline data readout demonstrated that adding UV1 to the standard of care pembrolizumab did not lead to clinical benefits in progression free survival or overall survival in the late-stage head and neck squamous cell carcinoma (HNSCC) patients recruited in the study. The study therefore did not meet its primary and secondary endpoints. UV1 continued to demonstrate a positive safety profile in line with other UV1 studies with similar events observed in the control arm and good tolerability.
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About FOCUS
The FOCUS trial (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study) is an investigator-sponsored, randomized, open label Phase II clinical trial. The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment as a first-line treatment in metastatic patients or a second-line treatment in patients with recurrent PD-L1 positive head and neck squamous cell carcinoma. Professor Mascha Binder is the principal investigator for the trial, which is sponsored by the Medical Faculty, University of Halle-Wittenberg in Germany. The first patient in the FOCUS trial was enrolled in August 2021, and patients have been treated at 10 sites across Germany. The trial is investigating the tolerability and efficacy addition of UV1 to standard of care treatment with programmed death receptor-1 (PD 1)-blocking antibody pembrolizumab versus pembrolizumab monotherapy. The 75 patients indicated for treatment with pembrolizumab have been randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint is PFS rate at 6 months after first administration of study medication. Secondary endpoints include PFS and OS (overall survival, by Kaplan-Meier estimate), objective response rate (ORR), duration of response (DOR) and safety, with minimum 12 months follow-up. As OS is recognized as the determining efficacy measure in guiding further development in this cancer indication, the topline results will be disclosed 12 months after enrollment of the last patient, allowing simultaneous disclosure of both PFS and OS.
About UV1
UV1 is a universal cancer vaccine designed to induce a specific T cell response against telomerase. UV1 consists of long, synthetic peptides, representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T cells. These CD4+ T cells have the potential to provide inflammatory signals and T cell support that are believed to be critical for triggering a strong anti-tumor immune response. Following intradermal injection, antigen presenting cells (APCs) in the skin are exposed to the vaccine peptides. These APCs will process the peptides, and present vaccine epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T cells in the lymph nodes. Activated vaccine-specific T cells will then enter the circulation and search for cells displaying their cognate antigen in the context of HLA molecules.