Ultimovacs has announced the completion of enrollment of 75 patients and that the last patient has received the first dose in the FOCUS study.
“We are pleased to announce the completion of patient enrollment in the FOCUS trial, the third of five randomized Phase II clinical trials evaluating UV1 in different cancer indications and in combination with various checkpoint inhibitors,” added Carlos de Sousa, Chief Executive Officer at Ultimovacs. “We look forward to learning the impact of UV1, particularly in terms of overall survival, the most important efficacy measurement in cancer treatment. We expect to provide topline data in the second half of 2023 for the Phase II trial in malignant melanoma, INITIUM. For the Phase II trial in pleural mesothelioma, NIPU, we expect the full data, including overall survival, to be presented at a medical conference in the fall of this year. The results from these studies will increase our understanding of how UV1 can potentially improve outcomes for cancer patients and provide a foundation for our future pivotal clinical studies.”
FOCUS is an investigator-initiated Phase II randomized clinical trial sponsored by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs. The study investigates Ultimovacs’ therapeutic cancer vaccine, UV1, in combination with pembrolizumab versus pembrolizumab alone, as first-line treatment for patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). For these patients, pembrolizumab is a standard of care treatment.
The FOCUS trial is being conducted at ten sites across Germany and is led by Principal Investigator Mascha Binder, M.D., Professor of Medical Oncology at the Faculty of Medicine, University Hospital of Basel. Professor Binder is a renowned oncology clinician and researcher specializing in the analysis of immune-oncology treatments and their interaction with tumor tissues.
The topline results will include overall survival (OS) with minimum 12 months of follow-up in addition to progression-free survival (PFS), enabling a full assessment of the study outcomes. These data will be analyzed 12 months after the last patient was enrolled and is expected to be disclosed in the second half of 2024. The results will be announced through a press release followed by an in-depth presentation of the data at a medical conference and in a peer-reviewed journal.
The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council.