Hi Sagitarius,
Sorry I should have replied you yesterday. I think that they are showing on the slides that these trials are done, as in they are not actively recruiting & patients are at follow-up stage. You can imagine with so many trials happening & planned, that would be important to indicate that in a presentation, it’s hard enough for LT holders keeping up with everything, let alone people new to IMU’s pipeline!
As far as all “events” I don’t know, but we are in that last black square in the trial design “follow for OS” & obviously “Final OS data expected Q2 2022” does give us a clue there that the time may be close, however this is people’s lives we are talking about here obviously!
I think that the final patient’s death leading to the completion of the trial is very important & would require an ANN. (I hope my bluntness doesn’t offend anyone, when you have had a loved one pass of cancer, you do think about the reality of these things, not just “the numbers”).
The clinical trials registration was updated in January 2022 with anticipated primary completion in January 2022 & study completion in February 2022.
I think we should remember also we are in the middle of a pandemic & patients on clinical trials are affected as well. It is a possible scenario a patient became very unwell with COVID & recovered, I mean who knows, these things happen?
This is why I said in my post the other day that the anticipated end dates have been surpassed. This trial has now been running for 5 years almost. (Actual start date was August 2017). That’s not to say that all patients have been treated for this long, I’m absolutely not implying that. It depends on when they were recruited & started on therapy & we will just have to wait for OS data.
The primary endpoint for Ph2 in this HER-VAXX trial is clinical efficacy based on OS. (No. 3). So yes it’s important to let nature run it’s course, but I do think that if a patient or patients continues to survive, that at some point, IMU would need to call OS & report on trial data, with the disclaimer that OS is ongoing & the estimated follow up in trial design was 17.5 months.
That is not a bad look at all, & of course that can be updated later on. Time is obviously of the essence in Oncology. I’ve just posted screen shots below from the trial registration to make life a little easier.
Hope that helps Sag.
(20min delay)