Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced that the results from the randomized controlled Phase II clinical trial, NIPU, are published in the European Journal of Cancer. The trial investigates the effect of adding Ultimovacs’ cancer vaccine UV1 to second-line treatment with ipilimumab and nivolumab for patients with pleural mesothelioma (NCT04300244).
NIPU is an investigator-initiated, open-label, multi-center Phase II trial sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. Six university hospitals in Australia, Denmark, Norway, Spain, and Sweden participated in the trial. 118 patients were randomized between June 2020 and January 2023.
The study did not meet its primary endpoint of improved progression-free survival (PFS) based on blinded independent central review (BICR). Analyses on the secondary endpoints, objective response rate (ORR) by BICR and overall survival (OS), showed a significant benefit of adding the UV1 vaccine to ipilimumab and nivolumab. Local assessment demonstrated an improved PFS among patients in the vaccine arm for all histological subtypes combined, and new subgroup analysis demonstrates further improvement for the epithelioid subtype. The epithelioid subtype represents approximately 70% of all patients with mesothelioma.
The safety profile of the combination of UV1 plus ipilimumab and nivolumab observed in the trial was consistent with that of ipilimumab and nivolumab alone, confirming the good safety profile for the UV1 vaccine.
