RE:RE:AACR Poster - very interesting I don't know what's going on with this press release. It reads as a fairly incomplete part 2 with lots of enrollment still to come, a smattering of hopium for efficacy but not quite getting enough of those all important PRs and manageable safety. It doesn't scream "STOP THIS TRIAL" and yet that's exactly what happened.
Extreme conservatism?????
or maybe the devil is in the detail and we'll see more in the poster. My cynical eye is drawn to the vagueness of how the safety data is presented, it surely won't be like that in the poster. It's not unknown for a PR and poster to lead to very different reactions from investors when they get a gut punch on safety from the poster.
IDK, I'll wait for the poster, not too long, should be warts and all.
palinc2000 wrote: When were these results tabulated or extrated?
Why the pause?
I think it is all related to the cash situation.
I smell a partnering deal as soon or soon after FDA apptoves the revised protocol
Wino115 wrote: So, the safety issues were not all that big --basic things we knew and <12%. Still issues, but not the severe ones like seen in some ADCs. Marsolais comment about being on target and internalizing is helpful.
We also know that there were some level or either partial responses or stability in ovarian, TNBC and prostate. So 3 of the cancers seen. This is the first time we've actually heard about TNBC and that's a real positive. Stable disease is not the ultiate result you want but does show there is an effect going on --the "concept" is there because a person with (avg) 8 previous treatments where nothing worked anymore actually survived and the metastices were controllable for some pretty long periods as you see --one for 40+ weeks which is a long, long, long time for someone on death's door. Those SD rates and lengths are in there with other good cancer drugs.
Nice to see the rock star investigator was willing to put her name on the PR talking about the results on the poster. While it's still very important to see this data and the charts, we now know it will be for the full part 1 and 2 (so far) of 38 patients. For a first time shot, seeing decent safety a few PRs and some very long SD's is actually a pretty good start. It could just stay at that, but if there is something going on in there, which it seems there is now, finding a way to see more of the effect that is keeping the tumor stable to actually get in there and shrink it is what's needed. It sounds like they will be trynig a few different techniques to "expand the window". Overall, while we still need to see this data and to produce even better data, it's a nice start to round 3 in dosing the drug and seeing if it hits targets. It's certainly encouraging and not discouraging and makes the intereim stop seem more about them seeing it's having an effect but it needs to be tweaked to be better and we can see that --it's relativel safe and we see stability, so pause, reevaluate and let's get it coming back in a more effective way.