In March 2024 Ultimovacs announced topline results from the Phase II clinical trial INITIUM, which evaluates the therapeutic cancer vaccine candidate UV1 as a first-line treatment in unresectable or metastatic malignant melanoma. While primary and secondary endpoints were not met, Ultimovacs seems resolved to continue investigating UV1.
Falling short
The primary endpoint of the study was to investigate progression-free survival (PFS) in the experimental arm compared to the control arm. The experimental arm comprised UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab. Secondary endpoints included overall survival (OS), objective response rate (ORR), and duration of response (DOR) and safety. The combination treatment approach showed “similar clinical benefits”, which means that “the primary and secondary endpoints of the study were not met”.
The median PFS was not achieved in either of the arms, and the Hazard Ratio (HR) between the arms for PFS was 0.95. While UV1 “maintained a positive safety and tolerability profile”, the evaluation of secondary endpoints did not reveal a difference in OS or ORR.
A high bar
Dr Jens Bjørheim, Chief Medical Officer, commented that the team had “set a very high bar” for the vaccine candidate by comparing it to the ipilimumab and nivolumab combination, which is “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 complete the analysis of the full data set in depth to gain further insights on UV1’s effects.”
Dr Bjørheim thanked the patients for “their trust” and the investigators for “their collaboration”.
Looking for the best path forward
Dr Carlos de Sousa, CEO, emphasised that the team will “remain committed to UV1”.
“Our objective is to define the best path forward for our development strategy for UV1.”
Dr de Sousa reportedly told investors that “this was a failed study, not a failed UV1”.
“I think it is important to reinforce that notion. UV1 has shown benefits, and we hope that it will continue to show these benefits.”
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