Let's assume cabo has already been approved for 2nd line RCC, and it beats Sunitinib with statsig in PFS and OS. And NCT01835158 is a head to head compare with existing 1st line drug with 150 patients. Is it enough for EXEL to ask FDA to move cabo up to 1st line?
The 5 v 7.5 assumption is broken. Smashed! The focus is on how afinitor is behaving comparing to expectation.
If it's still 5, our PFS is getting closer to expected OS.
Thx. So, mostly you were focus on drug concentration and metabolism, not related to pathology, right? Would that applies to any other chemicals?
Social, I remember once you said cabo has a better chance in HCC than RCC. Would you tell us the biochemical mechanism behind it? Thx.
Not necessarily. If 5 vs 11, on 4/11/2015, we've already passed the 69% mark. Even 6 vs 11, we've reached that mark. So long as afinitor doesn't outperform expectation way too much, we are in very good shape.
I've a feeling that meteor will be the last trial MMM can run. After that the acquirer will take over HCC trial per their agreement. The acquirer doesn't like MMM to run celestial and do the design for future trials. Of course, MMM will get a big amount of money to spend on fancy haircut every day.
actually, we have more info than that. For estimation purpose, 50% enrollment at beginning of second quarter, 100% by the end of June are very useful for simulation or calculation. 5 months, 7.5 months, 5.5 months, 10 months, 12 months, 14 months are numbers for you to play.
“How many PFS events of the first group has happened till now?" This is a question everyone wants an answer but the analysts may not ask.
Or the answer is "This trial is ongoing, but we cannot disclose the numbers. We will let everybody know ASAP after the analysis done."
A question about crossover for you guys familiar with trial design. What does "no crossover allowed"? No afinitor branch to cross over cabo, and vice versa, that's for sure. How about crossing over to the third, fourth...approved drugs after progression? I think it's normal in general practice?
That's way too optimistic. My crystal ball told me: if 6 vs 14, on 5/15/2015, events will be more than 70%, greater than preset 69%. or 5.5 v 15. If cutoff date is after June, pfs will be greater than everolimus' OS. If everolimus performs exactly as anticipated, trial will be called off by then.
Exactly. Now how good the PFS looks like depends on how everolimus outperform 5.5 months. If only 6 months, we are close to 12. That will be giant good. OS is another story, many good PFS data didn't translate into good OS, cabo included. It curbs progression, and mutation eventually revengefully lead to faster OS event.
From 2014_10_27 to 2015_04_13, after about half year, they finally update celestial. On 2014_12_02, you can say exaclty nothing to update. On 2015_04_13, you can say next to nothing. One "not yet recruiting" mexico city site was added, and 4 "recruiting" sites were "terminated"(not "Active, but not recruiting"). Nothing else!
It sounds so weird. Before 2014_10_27, you can see them update recruiting status every 10 days or so. What happened with celestial during this half year? In a money saving mode waiting for meteor good result so we can raise some funds to run full speed with celestial?
At least they should give a little bit more hints on METEOR events count with this PR. Fast track is a surprise and not a surprise. They can give it to anybody with merits. We are running a trial against 5.x months, not 2.x months. FDA should award us who got a much higher bar to jump over.
If 15 months and 20 months medians hold true, my voodoo crystal ball told me, more than 40% of first 375 patients have encountered OS events. It's sad, and I didn't believe my crystal ball told me so. With these numbers, OS data in the interim(or, whatever you call it) analysis might not be matured(btw, crystal ball also told me we will have final analysis on next Feb or around), but surely will give us some ideas.