RE:RE:RE:RE:RE:RE:RE:RE:QuestionsRemember Christian mentioned to me that they might have soething to present at the AACR conference, which we think he was referring to one in October. If that were true, then he must be assuming some quick success in phase 1b and a late breaker presentation. But I am not 100% sure if it true.
Key points from today:
1.) POC has been achieved. The drug has been significantly derisked
2.) The drug had a positive impact across three different types of cancer
3.) One tumor vanished completely (I am guessing that was not one of the targeted tumors in that patient and just something they observed)
4.) For one patient, they had 11 cycles of treatment! And only quit to get back to a more normal ,trial free life. Who knows how long they could have stayed on.
I think this is just about as much as we could have hoped for following the 1a.
TH is planning to run with the first type of cancer to get over the 1b finish line and pursue a phase 2 ASAP. The number of different angles to pursue beyond that are many. Different chemo bombs, different dosing schedules, different cancer types. It is unlikely they will do most of this themselves.
qwerty22 wrote: There's going to be overlapping data coming out from this point forward. Interim 1b likely comes before 1a publication. The full 1a data set might not matter all that much by the time it comes out if they have larger and clearer 1b data emerging on safety and efficacy. I guess when I first mentioned poster publication it was imagining something coming out for the Fall conference season in which case it might clear up some uncertainties. I think by 2023we will have hopefully moved on from wondering about the 1a data.
SPCEO1 wrote: Yeah, you must be correct on that. I will check the transcript when it becoes available to s ee what Paul actually said, but your take has to be the correct one.
jeffm34 wrote: That published evaluation will be for phase 1a only. Phase 1b will still be ongoing well into 2023. Final readout for that portion would be 2024 at the earliest
SPCEO1 wrote: Paul mentioned that there will not be a published evaluation of the trial until early 2023, if I heard him correctly, and that presumably would include phase 1b as well as phase 1a.
They defintely cherry-picked the info they shared with us but the important point remains the same - the drug worked as expected on some patients. That is the first time the company has stated that/. We do not have to worry so much now about it being a complete flop in phase 1. To me that was very encouraing info to hear directly from the company. I was already encouraged by Juniper88's report but this confirmed the drug was working by getting into some cancerous tumors and either reducing their size or stunting their growth over a long time period.
I am not sure what you think is unclear. At 420mg there were toxicities and Christian couldn't have been clearer about the absence of them at the 300mg level. That is not even new info as we have known that for a while.
qwerty22 wrote: One problem is they are essentially still cherry-picking what they want us to know. The 1a data would need to go to a conference poster to get the full picture.
Christain was talking about patients choosing to drop out to get back to normal life. Interesting Juniper thought the burden of clinic visits was high with this trial. Must be disease progression and general frailty as an issue too. He did say some of the 420 toxicities led to withdrawal but also that outside that toxicity wasn't an issue for dropouts. Seems quite mixed and unclear.
palinc2000 wrote:
Only 2 of the 18 patients in Phase 1a remain in the trial...Do we assume that most of the 16 did not survive long enough?
qwerty22 wrote:
Seems to me they were quite defensive over oncology. I'm wondering if they are concerned that with 18 enrolled and only one clear PR that this data will be seen negatively.
For me this update is pretty good. The only real downside is it came 6 months late. It is blown away data but they hit everything they needed to hit.
I guess they are looking forward to a sizeable data set coming out of 1b and as we have said it's likely too early for that to have materialized yet.
I thought some of the colour Christain gave on the "responders" was useful. There's certainly a suggestion that there's some resistance around those patients given that in prior treatments they quickly failed on taxols. You could surmise with the PR response patient that they "beat" docetaxel.
Overall though I get the sense they are still being very cautious and conservative. Could be a while before we hear about 1b patients. Feels like a big derisk but no fanfare about that.
StableGenius97 wrote: We out here showing cancer efficacy in cancer and we out here talking about egrifta. Not the game. Egrifta. We talking about egrifta