Ultimovacs has completed the enrolment of patients in its Phase II clinical trial evaluating the UV1 cancer vaccine, together with pembrolizumab, in head and neck cancer patients.
Sponsored by the Martin-Luther-University Halle-Wittenberg, the First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study (FOCUS) trial is being carried out at ten German sites and will be led by Professor Mascha Binder from the University Hospital of Basel.
Its primary objective is to determine the performance of UV1 as an add-on to pembrolizumab treatment in patients with PD-L1-positive head and neck squamous cell carcinoma.
The study, including a total of 75 patients, will assess the efficacy and tolerability of the combination therapy in 50 patients, and pembrolizumab monotherapy in 25 patients.
A progression-free survival (PFS) rate at six months after the first administration of the study medication is the primary endpoint.
Secondary endpoints include PFS, overall survival (OS), objective response rate, duration of response, and safety, with a minimum 12-month follow-up.
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Topline results will be announced 12 months after enrolment of the last subject, allowing the disclosure of both OS and PFS simultaneously.
Ultimovacs CEO Carlos de Sousa said: “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.”
Other Phase II studies for evaluating the universal cancer vaccine UV1 are ongoing for treating pleural mesothelioma, malignant melanoma, non-small cell lung cancer, and ovarian cancers.
An innovation grant of up to Nkr16m ($15.8m) was provided by the Norwegian Research Council for the FOCUS trial.