Carlos svarer på spm om hvorfor INITIUM har blitt utsatt flere ganger:
“The INITIUM study is supposed to read the data when 70 patients progress, or die. We were expecting those 70 events to have happened in the first half of 2023. It didn’t happen. Which is of course very good for patients. Then, we changed guiding to the second half of 2023, and then again, we didn’t have the 70 patients progressing or dying. We changed to the first half of 2024, and what we have observed is that basically [we believe?] patients are now in a kind of a flat line, the patients that responded [to treatment] are now not progressing (vifter flatt med hendene). So we looked at some of the forecasting, and it could take months, even years for us to get to 70 events. Then of course, we want to bring this to patients, so what we did, we talked with advisors, we talked with investigators, and then we submitted a protocol amendment to the authorities to the countries where we are running the study, they were all in agreement. So this means that in mid january we will start analysing the data, and that will be available in march / april. This is very important, because by mid april the last patient has passed 18 months follow-up period [dette har vel strengt tatt skjedd ved cut-off-datoen, wvh anm.], and the first patient will have been in the study for 42 months. So it is quite an extended period, and the median observation time is 24 months. This gives us confidence that the results – whatever they are –are already there, and [are] not dependent on the last endpoints to happen (during this period of time). So, I think it’s going to be a very exciting time, because clearly clearly something is happening in that study because the study population is faring very differently from the historical data of ipi / nivo, which are the combination we are using UV1 with.”
Uthevningene er mine egne.