Ultimovacs’ CEO comments
To learn more, BioStock reached out to with Ultimovacs’ CEO Carlos de Sousa for a comment.
Carlos de Sousa, vd Ultimovacs
Carlos, could you give our readers a more in-depth explanation for this updated guidance in the INITIUM timeline?
– According to the original study protocol, the trial will stop for a data readout when 70 patients have displayed disease progression, or death. At the time, the initial guidance was based on published historical data looking at disease progression within this indication for patients receiving the ipilimumab/nivolumab combination. According to those data, we could estimate that an initial readout from 70 patients would occur during the first half of 2023.
– We now know that patients are taking longer to show signs of disease progression, which is obviously very good news for them. Consequently, we need to change our guidance for readout timeline, which will be the second half of 2023.
– We started patient recruitment for this trial in June 2020 and enrolled all patients over two years. That means that soon all our patients will have received treatment for at least one year, and some patients that will have been in the study for three years. We still need to see how significant of a role UV1 is playing in this.
– The extension of timeline has minor financial impact for Ultimovacs.
Do you know if the extended study timeline is in any way related to UV1 efficacy?
– We don’t know that because this is a randomised, blinded study. So, we will not know until the 70-patient threshold for a data readout is reached, and we receive the results.
How and when will you know if UV1 is responsible?
– When 70 patients have displayed disease progression, the data will be compiled and the CRO will communicate the results to us. We will be looking at the primary endpoint PFS which gives us the difference in disease progression outcomes between each treatment arm. In terms of secondary endpoints, particularly safety and overall survival, will also be very important for determining how to proceed after this study. Over the next few years after read-out of the primary endpoint we will continue to follow all patients for survival.
Overall, what does this all mean for the INITIUM trial?
– Well, for now, we have extended the timeline for a data readout to the second half of this year. Once we receive the results, and if we see that UV1 has a meaningful clinical benefit, then the question will be, how large is that benefit? This may influence how we present the INITIUM data to the authorities and how fast we can get UV1 to the market, for the benefit of the patients