jfm1330 wrote: Remember Levesque last August said that as soon they would see efficacy they would report it. It was in phase Ia, so I don't think they need two patients with the same cancer type to report it. They just need scientifically solid results and the will to report it. Short term efficacy in my understanding is a partial response, and that means a tumor shrinkage of 30% or more per RECIST criterias.
That being said, sometimes it can be complicated. Reality and RECIST criterias are two different things. Somebody I know has a neuroendocrine cancer metastasized in the liver and in the bones. The primary tumor (small bowel) was surgically removed. So he only has metastatic cancer in his body, mainly in the liver, but with small tumors in the bones. After treatment his doctor told him that the biggest tumor in the liver shrinked by 30%, but it was harder to say for all the other smaller tumors. So probably a case like that would not qualified as a partial response per RECIST criterias, but on the other hand there is clearly efficacy. Since treatment, his cancer is stable, that is for 18 months now. So with cancer, doctors can see clear efficacy for them with their experience, but maybe a company cannot report it it as efficacy per strict scientific criterias. So maybe Thera are dealing with cases like that in advanced metastatic cancers.
SPCEO1 wrote: As we are painfully aware, the Canaccord analyst has had THTX in his penalty box for a long time. But he put out a prompt report this morning (recall it took him almost two weeks, which is incredible, to put out a report on THTX's last quarterly earnigns call) noting the start of the phase 1b which included a commitment to factor cancer into his model once proof of concept is seen.
When might that be seen? It could actually be earlier than we have been thinking in the phase 1b. If everything went perfectly optimally (which basically never happens) it would be possible we saw results from the second scans confirming preliminary efficacy by the end of June. How, you ask? Well, the pahse 1b got started earlier than we expected and some/all of the first three 300 mg dose patients may have rolled right into the phase 1b. If so, the phase 1b effectively started when those first three patients got their first dose, which I am guessing occurred in late March since in mid April they had complete their first cycle of treatment (based on what was said on t he mid-April conference call).
Now, I don't know the specific rules areound declaring preliminary signs of efficacy. First I have to assume you need at least two instances of tumor regression afer twelve weeks and two scans. This must have to be in the same cancer type as well. So, if two of those first three patients has the same cancer type and both showed tumor regression, then THTX can declare preliminary signs of efficacy, I think (any help with the rules around declaring preliminary signs of effcicacy from those in the know would be appreciated). The chances of all the conditions being met are tiny but it is fun to think about.
My contact who mingled with the THTX honchos before the annual meeting yesterday heard there was to be a discussion at the board meeting following the AGM yesterday discussing some recent input from the investigators on the trial. Could that have been the results of the first scan? Were those reults positive or negative? We can only speculate but thereis a very small chance THTX is already half way there to declaring preliminary efficacy.
Then we can see how much credit Canaccord and the other analysts will give THTX for their cancer program. Whatever they give will be heavily discounted due to how early we are still in the testing program for TH-1902. But at least it will be something!
If you really want to keep dreaming, then hope that two of those first three 300mg patients had ovarian cancer and both show tumor regression. If that tumor regression is as good as seen with normal docetaxel patients where docetaxel is the first line of therapy for ovarian cancer, then things could speed up very quickly for TH-1902. A phase 2 study would be started pronto and, if TH-1902 was to reveal that it is better and safer than normal docetaxel treatments, it might get anaccelerated approval sometime in 2023 and it should then quickly become the first line treatment for ovarian cancer.
OK, now it is time to come backdown to earth as the chances of any of that happening have to be 1 in 1000 or less. Everything would have to go right and that never happens, especially when you are dealing with very, very ill patients who have been through all sorts of cancer therapy already.
Even so, we may get a preliminary efficacy signal sooner than we thought. but it likely will not be on the optimal type of cancer from our prespective, which I believe would be ovarian.