Ultimovacs has announced the topline results of  NIPU, an investigator-initiated Phase II trial in patients indicated for second-line treatment of malignant pleural mesothelioma (MPM).

Based on central review, the study did not meet the primary endpoint of PFS. Investigator assessment of the primary endpoint, a pre-defined supportive analysis, showed a statistically significant positive PFS benefit for the patients in the UV1 arm. The central review was performed by a blinded, independent clinical research organization, whereas the investigator assessment was performed by specialized radiologists at the study hospitals.

Based on central review, the study did not meet the primary endpoint of PFS.”

Current data indicates improvement in overall survival in the UV1 arm over the control arm, but the data need to mature before a conclusion can be reached. The safety profile of the combination of UV1 plus ipilimumab and nivolumab (treatment arm) observed in the trial was consistent with the safety profile of ipilimumab and nivolumab alone (control arm), confirming the good safety profile for UV1. Further results from the study will be presented by the sponsor at an upcoming medical conference, states the company. The patients will continue to be monitored for efficacy and safety endpoints over the next years.

Further, the data show a positive trend towards improvement in overall survival in the UV1 arm over the control arm, although it is still early, and the data need to mature before we can reach a conclusion.”

“The results showed that the NIPU trial did not meet the primary endpoint of PFS based on blinded independent central review. Based on investigator assessment, a pre-defined supportive analysis of PFS, the study showed a statistically significant improvement in PFS for patients receiving UV1,” says Åslaug Helland, Principal Investigator in the NIPU trial and Professor at Oslo University Hospital. “Further, the data show a positive trend towards improvement in overall survival in the UV1 arm over the control arm, although it is still early, and the data need to mature before we can reach a conclusion. Overall survival is the most important efficacy measure in cancer treatment. We are encouraged by the results and look forward to further understanding the vaccine’s role in improving survival in this hard-to-treat patient group. Detailed, updated results will be shared at an upcoming medical conference. We wish to thank the patients and investigators for their participation and important contributions to the NIPU study.”

The NIPU study

The NIPU study is sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. The randomized, open-label, multi-center trial with 118 patients conducted in Scandinavia, Spain, and Australia was designed to investigate if combining UV1 with checkpoint inhibitors ipilimumab and nivolumab would provide a benefit compared to ipilimumab and nivolumab alone, in patients with malignant pleural mesothelioma as a second-line treatment, after first-line treatment with platinum-based chemotherapy. The first patient in the NIPU trial was enrolled in June 2020, and the last patient was randomized in January 2023.

We are now even more optimistic about the ongoing Phase II clinical development program, which will report data from two additional studies in different cancer indications within a year.”

“NIPU was a tough challenge because mesothelioma is known as a very hard-to-treat form of cancer particularly in second-line treatment where there is no established standard of care. Despite not meeting the primary endpoint of PFS based on central review, we are encouraged by the overall results including safety, PFS based on investigator assessment, and preliminary overall survival. We are looking forward to learning more about the data and especially the overall survival, when the data have matured,” says Carlos de Sousa, Chief Executive Officer, Ultimovacs. “We are now even more optimistic about the ongoing Phase II clinical development program, which will report data from two additional studies in different cancer indications within a year.”

Photo of Carlos de Sousa: Ultimovacs