RE:RE:RE:RE:RE:RE:New Corporate Presentation upThings clearly got a little hairy for them at the 420mg level and this is what has delayed things so much. I really wish there were dates along the bottom to indicate the timeline more accurately. They had the chance to tell us some of this earlier and chose not to and I have to assume they are showing us more now because they now have a confidence level that is pretty high about how it is going to end - with the 30MG dose being the RP2D. So, that is a good sign from this presentation update. That long period without a presentation on the website from early December to late January if I recall correctly, probably was a period of greater uncertainty for the trial and thus they just clammed up until they had everything sorted out. I have to believe they were pushing for 420mg and the doctors running the trial were hesitant thereby slowing things down. The short dip to 360 seems to be a response to that and they must have had some success there that allowed them to try at 420mg again. When we spoke the other day they mentioned something about thinking about 360 before deciding on 300.
The whole way the trial developed from a dosing perspective (not a time perspective) looks pretty normal. You keep increasing the dose until you have trouble and then step back to a dose that offers the best combination of safety, ability to dose more frequently and for a longer period of time. Because the more frquent and longer duration of dosing may be an important part of TH-1902 value proposition, erring on the low side on safety makes sense to me.
Also, let's hope patient 2 had a sortilin overexpressing type of cancer as they got enough doses to see if there was any preliminary signs of efficacy.
qwerty22 wrote: I think this complicated picture is probably quite normal and why most companies don't share meaningful data until the end of the process where it can all be put into perspective. With this update I think this is at the more transparent end of the spectrum in terms of letting us know how the trial is unfolding (sans efficacy of course).
qwerty22 wrote:
It looks like a complicated picture at 420. First two patients dropout at 420 (let's assume the worst - for toxicity). Then they appear to 'dabble' with an intermediate dose for patient 8. Then the 3 420 patients with 1 DLT so they move to enrol 3 more at 420, but then they stop at one patient and move back to 300. Seems like an intense decision making process at that dose. Looks on the surface risk averse and a fairly rapid retreat from toxic 420. As long as there is some hope at the 300 dose then that seems fine. There has been a lot of criticism of late that in the pursuit of efficacy companies have been pursuing too toxic doses.
There would be a lot more comfort if we knew that they are moving forward with 300 not just because 420 is too toxic but because they see something positive happening at 300. The huge missing piece atm.
qwerty22 wrote:
I'd say you're right.
SPCEO1 wrote: It seems like it refers to the 2nd footnote which says this is the currently available dose. But I am not 100% sure of that. Probably 95% sure but wonder if there are other theories out there.
SPCEO1 wrote: Anyone want to take a guess as to what the blue "2" means under the first patient at the 300mg level?
SPCEO1 wrote: https://www.theratech.com/static-files/ddb819a0-33ef-485d-aae8-d587b8cb36bf
I don't think it tells us anything we did not already know or presume but have only had time to glance at it.