Ultimovacs ASA announced updated data analysis from its UV1 Phase II NIPU trial in malignant pleural mesothelioma at the 2024 ESMO Congress in Barcelona, Spain. The trial evaluated the addition of UV1, a telomerase vaccine, to immunotherapy with ipilimumab and nivolumab as a second-line treatment. While the trial did not meet its primary endpoint of improved progression-free survival (PFS), subgroup analysis revealed a notable benefit in the epithelioid subtype, which constitutes approximately 70% of mesothelioma cases.
The NIPU trial, an investigator-initiated, randomized, open-label, multi-center Phase II trial, was sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. It involved 118 patients across six university hospitals in Australia, Denmark, Norway, Spain, and Sweden, randomized between June 2020 and January 2023.
Clinical Outcomes
The ESMO 2024 poster presentation highlighted a significant clinical benefit within the epithelioid subgroup. Patients treated with UV1 in combination with ipilimumab and nivolumab demonstrated a median PFS of 5.5 months, compared to 2.9 months for those receiving immunotherapy alone. Furthermore, the updated data showed a positive difference in overall survival (OS) with UV1 treatment at the latest patient follow-up.
Jens Bjørheim, Chief Medical Officer at Ultimovacs, stated, "Zooming in on the different subgroup analyses, we see persistent survival signs especially in the epithelioid mesothelioma patient subgroup, supporting a rationale for further investigation of UV1 in this indication, which continues to represent a high unmet medical need." He added, "At Ultimovacs, our goal is to provide new treatment options for patients that do not benefit from the current standard of care and we will discuss these data and potential next steps with key stakeholders and the medical community."
Previous Findings
Ultimovacs previously announced the publication of the Phase II NIPU trial results in the European Journal of Cancer in March 2024. These analyses of secondary endpoints, including objective response rate (ORR) and overall survival (OS), indicated a benefit from adding the UV1 vaccine to ipilimumab and nivolumab. The safety profile of the combination was consistent with that of ipilimumab and nivolumab alone, confirming the good safety profile for the UV1 vaccine.
About UV1
UV1 is a universal cancer vaccine designed to induce a specific T cell response against telomerase. It consists of long, synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T cells. These CD4+ T cells have the potential to provide inflammatory signals and T cell support that are believed to be critical for triggering a strong anti-tumor immune response.
Future Directions
Ultimovacs is actively investigating the safety and efficacy of UV1 across a range of cancer indications and immunotherapy combinations. Their ongoing Phase II program includes five randomized clinical trials in melanoma, mesothelioma, head and neck cancer, ovarian cancer, and non-small cell lung cancer, with over 750 patients enrolled in the U.S., Europe, and Australia.
