Lars Nieba om andre studier enn paradigme på presentasjonen på webcast 2. April:
"We will pause other clinical studies post completion of the current cohort. In more detail that means Archer-1 and DLBCL, we will still recruit on the current cohort and then we will have a deeper look into the result.
Om svarene på Archer-1 i spørmålrunden på webcast med Lars Nieba, Jan Egberts og Malene Brondberg 2. April:
Malene B: “Can you maybe, Lars, say a little bit more about the Archer trial. How many patients do you expect to enroll before the trial is put on hold?”
Lars N: “As we mentioned in the Q4-call for the archer-1 trial, we are two patients away from the final cohort, ehm, from that current cohort. Can be one or two, ehm, its not a lot of patients that we still need to recruit for that one and then we will evaluate the data.”
Malene B: “How does the decision to put Archer-1 on hold affect the planned accelerated access to second line FL to confirm the phase 3 trial.”
Lars N: "This year we have looked into more detail how to move ahead with Betalutin and, ehm, we think that Betalutin is a very potential drug and it can be more seen of as a stand alone possibility. So, we feel, that going into things like consolidation on another area will give up some of our potential. The Archer-1 trial is very important for us, because the combination with rituximab is very safe, an give us enormous , ehm, potential. The question which we now need to think and is thought out of with the opinion leaders is how to best position betalutin. And that we are currently working on that, and we will come back at the next occasion in more detail in how we want to position betalutin in the second line FL.
Malene B: “We have a follow up question on the Archer-1. Just to clarify, what is the plan, how many do you need to enroll in the last cohort, and maybe a little bit about the timing for of it. Lars?”
Lars N: "As mentioned the timing is a little difficult for me currently as we are in the covid situation. Our patients are high risk patients. On average, I think, we have around whatever 68 years old patients, might even be a little older. As we would need to carefully look at we really can go to the hospital. So, its really only a few number of patients, which we still need for Archer-1, but giving any timeline when the recruitment will be done is in the current situation very difficult. What was the other part of the question?
Malene B: “How many patients we need in the last cohort?”
Lars N: "As mentioned to my knowledge its one or two patients in that we need.
Malene B: “How many patients de we have when cohort 1 and 2 is fully recruited. Is it six or nine patients? Can you say something about that?”
Lars N: “Im sorry, I need to follow that up, and I don’t know that by heart, no.”
Gleder meg til den dagen jeg/vi (og Lars Nieba?) får mer klarhet i the grand mysterium Archer-1.