The combined treatment of UV1 with ipilimumab and nivolumab showed similar clinical benefits as treatment with ipilimumab and nivolumab alone, meaning the primary and secondary endpoints of the study were not met.

Ultimovacs has reported results from the Phase II clinical trial, INITIUM, evaluating the company’s therapeutic cancer vaccine candidate UV1 as first-line treatment in unresectable or metastatic malignant melanoma.

The study’s primary endpoint was to investigate progression-free survival (PFS) in the experimental arm (UV1 plus treatment with checkpoint inhibitors (CPIs) ipilimumab and nivolumab) as compared to the control arm (ipilimumab and nivolumab alone). Secondary endpoints included overall survival (OS), objective response rate (ORR) as well as duration of response (DOR) and safety. Topline data demonstrated that the combined treatment of UV1 with ipilimumab and nivolumab showed similar clinical benefits as treatment with ipilimumab and nivolumab alone, meaning the primary and secondary endpoints of the study were not met.

With the 18-month minimum follow-up of the patients in the trial, the median PFS was not reached in either arm, and the Hazard Ratio (HR) between the arms for PFS was 0.95. Evaluation of secondary endpoints did not show a difference in overall survival and objective response rate between the arms.”

With the 18-month minimum follow-up of the patients in the trial, the median PFS was not reached in either arm, and the Hazard Ratio (HR) between the arms for PFS was 0.95. Evaluation of secondary endpoints did not show a difference in overall survival and objective response rate between the arms. UV1 maintained a positive safety and tolerability profile.

Ultimovacs will further analyze the full data set while continuing to advance its ongoing Phase II trials for UV1, it states.

Ultimovacs had set a very high bar for UV1 by comparing it to the ipilimumab and nivolumab combination, currently considered the most effective treatment for this patient population. Nevertheless, we are disappointed that UV1 did not add further clinical benefit for these late-stage melanoma patients in the INITIUM trial.”

“Ultimovacs had set a very high bar for UV1 by comparing it to the ipilimumab and nivolumab combination, currently considered the most effective treatment for this patient population. Nevertheless, we are disappointed that UV1 did not add further clinical benefit for these late-stage melanoma patients in the INITIUM trial. Looking forward, our first objective is to complete the analysis of the full data set in depth to gain further insights on UV1’s effects,” said Jens Bjørheim, Chief Medical Officer, Ultimovacs.

The universal cancer vaccine UV1

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical development program across various cancer indications with different biology and disease stages, in combination with different checkpoint inhibitors. The topline data from INITIUM is the second readout among the five randomized trials in the UV1 Phase II clinical program. In October 2023, the UV1 Phase II trial NIPU in malignant mesothelioma reported a clinically meaningful overall survival benefit in the patients receiving UV1 vaccination on top of ipilimumab and nivolumab compared to ipilimumab and nivolumab alone, with no added toxicities. Per protocol, the overall survival results were statistically significant. In addition to the studies in malignant melanoma and malignant mesothelioma, Phase II studies are ongoing in patients with head and neck cancer (FOCUS), ovarian cancer (DOVACC), and non-small cell lung cancer (LUNGVAC). The data from the FOCUS trial is expected in the third quarter of 2024.

Photo: Ultimovacs