The trial is designed to evaluate the vaccine along with nivolumab and ipilimumab as a first-line treatment for unresectable or metastatic malignant melanoma. Credit: RVillalon / Shutterstock.

Norwegian biopharmaceutical company Ultimovacs is planning to release topline results from the Phase II clinical trial of its UV1 universal cancer vaccine in March this year.

The last subject in the Phase II INITIUM trial recently completed an 18-month follow-up, which has enabled the trial’s primary endpoint to be read out.

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The trial has aimed to evaluate the UV1 vaccine along with nivolumab and ipilimumab as a first-line treatment for unresectable or metastatic malignant melanoma.

It began in June 2020 and had enrolled 156 patients across multiple countries by July 2022.

The INITIUM trial’s original protocol required data analysis to start after 70 patients had either progressed in disease or died, which was expected by the first half of last year.

Progress towards this milestone has been slower than anticipated, leading to a protocol amendment near the end of last year.

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This change has been approved by regulatory authorities and allows for data readout after a minimum of 18 months of follow-up for all evaluable subjects, ensuring the statistical integrity of the trial.

Patients in the INITIUM trial have now been observed for 18 to 42 months, with a median expected observation time of nearly 24 months.

They will continue to be monitored for survival for another two years.

Ultimovacs CEO Carlos de Sousa said: “The initiation of the process for the INITIUM readout marks a noteworthy milestone in Ultimovacs’ clinical development programme for UV1.

“We look forward to announcing the topline results in March this year and plan to present the full data thereafter at a medical conference and in a publication in a peer-reviewed medical journal.

“There remains an unmet need in the treatment of metastatic melanoma, and UV1 has shown significant potential to be a therapeutic option for these advanced-stage patients.”