RE:RE:RE:RE:RE:RE:Expectations too high. Reset your animus.Good points but let me push back some. The assumption of 50% dropping out of the trial in 1a is not something we have actual data on, right? I don't remember seeing that. It may be a fair assumption, but it is a guess as far as I am aware.
Also, the target patients are supposed to be better than in the 1a on average so the efficacy results should be better.
I think the general lack of energy on today's call and the evasivness on TH-1902 questions specifically tells us there may be more to it than what you are suggesting. TH could have been similarily evasive while still leaving us feeling like they have seen something in the early phase 1b patients, They did not do that. Their commentary today was at odds with their recent presentation at the Cantor conference where they indicated the "think they have the key to unlock cancer cells". That suggested excitement was building as a result of the phase 1b info they were seeing but somehow that excitement was not present today.
If the problem is low enrollment, they probably should have admitted to that as it would have left me feeling better about the situation and more hopeful about the future. You may remember that I was surprised my cousin was accepted into the trial given how bad off she already was. She looked like she had just walked out of a German concentration camp. So much so that a very kind women followed her out of the Gettysburg clinic on her first visit there about a month before she started treatment and gave her some flowers the clinic had to wish her well. She clearly saw how bad off she was and extended that kindness to her, which was a real blessing to my cousin. My sister was even afraid she might die in her car on the trip to Gettysburg. Fortuately, my cousin was not in any pain right upuntil the end. The point I am trying to make is she did not appear to an untrianed eye to have 3 months of life left and yet she was admitted to the trial. Did that reflect difficulty in recruiting patients?
Wino115 wrote: It is, no doubt, but to be realistic let's recall that the requirements to enroll are still that you have to be heavily pre-treated and refractory to all standard treatment options. It's still just not a very easy population to deal with in any kind of trial.
For instance, let's just assume they see a good response rate of 40% but also have the same death or curtail rate as the 1a trial. If they've enrolled 25 people in the last 5 months, then a good response rate would be 10 people responding. If the dropout rate due to death/life issues/etc.. is roughly 50% (which seems to be a conservative number based on 1a), then maybe you had 5 get to the point where 3-4-5 cycles showed 30% tumor reduction. What if each was a different cancer? Then still no protocal extension.
I just think that we're seeing, once again, the difficulty in testing your therapy on the kind of population necessary to prove your science up. It's the right population to show amazing things, but it's got a much higher difficulty-rating based on patient baselines. It sucks, but we'll just have to be patient ....
Bucknelly21 wrote: The main thing as rusty said, 5 months in and you dont have efficacy? That seems to be a little concerning to me