Ultimovacs has announced the completed recruitment of 118 patients with pleural mesothelioma in the NIPU trial.
NIPU is a randomized, multi-center phase II trial initiated and sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. UV1 is being evaluated in combination with the checkpoint inhibitors ipilimumab and nivolumab as second-line treatment for patients with malignant pleural mesothelioma. The ipilimumab and nivolumab combination is standard-of-care treatment for patients with malignant pleural mesothelioma in Europe and the U.S.
Consistent with NIPU’s event-driven design, topline progression-free survival results will be disclosed after progression of cancer or death has been observed in a total of 69 patients, states the company. Data readout from the trial is expected during the first half of 2023.
Investigated in five comparative Phase II trials
Ultimovacs’ universal cancer vaccine, UV1, is being investigated in combination with checkpoint inhibitors in five comparative phase II clinical trials. NIPU is the second of these studies to complete recruitment of patients, following the INITIUM study in metastatic malignant melanoma. Topline readout from both these studies during is expected during the first half of 2023.
“We are entering a very exciting period for Ultimovacs as we are approaching topline readouts from the first two of the company’s five randomized phase II clinical studies investigating UV1,” says Carlos de Sousa, Chief Executive Officer at Ultimovacs. “If positive, these results have the potential to be transformative for the treatment of cancer patients with a severe unmet need, and for Ultimovacs on our mission to support these patients.”