In This Article:
Oslo, August 1, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced that an update from the Phase II NIPU trial (NCT04300244) in patients with malignant mesothelioma will be presented in a poster presentation at the 2024 ESMO Congress. The conference will be held in Barcelona, Spain from September 13-17, 2024.
Poster Presentation Details:
Title: Updated survival and vaccine response from the NIPU trial; A randomised, phase II study evaluating nivolumab and ipilimumab with or without UV1 vaccination in patients with pleural mesothelioma
Presentation Number: 1917P
Speaker: Vilde D. Haakensen, MD, PhD, Project Group Leader at the Oslo University Hospital
Date: Saturday, September 14, 2024
The first comprehensive data from the NIPU Phase II trial was presented at the ESMO Congress 2023. While the study did not meet its primary endpoint, UV1 in combination with the checkpoint inhibitors ipilimumab and nivolumab demonstrated clinically meaningful overall survival benefit with no added toxicities, compared to ipilimumab and nivolumab alone, in the second-line treatment of patients with malignant mesothelioma. The results were also published in the European Journal of Cancer in March 2024.
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About NIPU
NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized, multi-center phase II trial in which Ultimovacs’ universal cancer vaccine, UV1, is evaluated in combination with Bristol-Myers Squibb’s checkpoint inhibitors, nivolumab and ipilimumab, as second-line treatment of malignant mesothelioma. The trial sponsor is Oslo University Hospital, supported in the preparation and execution of the trial by Ultimovacs and Bristol-Myers Squibb.
The 118 patients were randomized 1:1 into two treatment arms. All participants receive treatment with nivolumab (240 mg every 2 weeks) and ipilimumab (1 mg/kg every 6 weeks) until disease progression, unacceptable toxicity or for a maximum of 2 years. Patients randomized to the experimental arm received 8 intradermal injections of UV1 vaccine during the first three months of treatment. The objective of the study is to achieve a clinically meaningful benefit in patients with malignant mesothelioma (MPM) after progression on first-line standard platinum doublet chemotherapy. Subsequent events emerging in patients in both arms of the NIPU study will continue to be monitored beyond read-out of the primary endpoint. The ipilimumab and nivolumab combination has recently been approved as first-line treatment for patients with malignant pleural mesothelioma in Europe and the U.S.