Pharma Focus America

Ultimovacs Shares Latest Update on Phase II NIPU Trial of UV1 in Second-Line Patients with Malignant Pleural Mesothelioma

Thursday, June 08, 2023

Ultimovacs, a clinical-stage biotechnology company specializing in novel immunotherapeutic cancer vaccines, has announced the topline results of its Phase II NIPU trial. The trial evaluated the effectiveness of UV1, Ultimovacs' universal cancer vaccine, in second-line patients with malignant pleural mesothelioma (MPM).

According to the findings, the study did not meet its primary endpoint of progression-free survival (PFS) based on central review. However, an investigator assessment of the primary endpoint revealed a statistically significant improvement in PFS for patients in the UV1 arm. The central review was conducted by an independent clinical research organization, while the investigator assessment was performed by specialized radiologists at the study hospitals.

While the data on overall survival in the UV1 arm suggest an improvement compared to the control arm, further analysis is required before drawing definitive conclusions. The safety profile of combining UV1 with ipilimumab and nivolumab (treatment arm) was consistent with the safety profile of ipilimumab and nivolumab alone (control arm), indicating a positive safety profile for UV1. Ultimovacs plans to present more detailed results at an upcoming medical conference, and the patients will continue to be monitored for efficacy and safety endpoints over the coming years.

Åslaug Helland, Principal Investigator in the NIPU trial and Professor at Oslo University Hospital, expressed optimism about the results. Despite not meeting the primary endpoint in the central review, the investigator assessment showed a significant improvement in PFS for patients receiving UV1. Helland emphasized the positive trend toward improved overall survival, though it is still early, and further data maturation is needed. Helland thanked the patients and investigators for their contributions to the study.

The NIPU trial, sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs, was a randomized, open-label, multi-center study involving 118 patients across Scandinavia, Spain, and Australia. Its objective was to assess whether combining UV1 with checkpoint inhibitors ipilimumab and nivolumab would offer advantages over ipilimumab and nivolumab alone as a second-line treatment for malignant pleural mesothelioma following platinum-based chemotherapy. The trial began in June 2020 and completed randomization in January 2023.

Ultimovacs CEO Carlos de Sousa acknowledged the challenges posed by malignant pleural mesothelioma, known as a difficult-to-treat cancer, particularly in second-line therapy where no established standard of care exists. Despite not meeting the primary endpoint according to the central review, de Sousa expressed encouragement based on the overall results, including safety, investigator-assessed PFS, and preliminary overall survival. De Sousa expressed optimism for the ongoing Phase II clinical development program, which will report data from two additional studies in different cancer indications within a year.

UV1, Ultimovacs' therapeutic cancer vaccine, aims to generate an immune response against human telomerase (hTERT), an enzyme crucial for cancer cell proliferation. Ultimovacs is conducting a comprehensive clinical development program to evaluate UV1 in various cancer indications and in combination with different checkpoint inhibitors. The NIPU trial results mark an important milestone in this program.

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