You all are telling me you're all betting on a drug, that you believe is going to provide better clinical results in patients that have already undergone treatment of another already approved drug and are advanced in their condition? This is the deal. This is where you're all placing your chips? Please tell me my unscientific, scheming calculating mind has this wrong....
That's correct, Everolimus got approved with a PFS 5 months vs 1.9 months. And Everolimus is owned by a huge pharma. I'll give you more ammunition: Sorafenib was approved with a PFS 5.5 months vs 2.8 months, against placebo too! Very tough for cabo to bet against this established franchise instead of placebo, huh?
The bar seems daunting high, right?
Let me show you the dismal side, of course, dismal for shorts. We've already seen this 5.x months vs 2.x months thing is well established over there, so in meteor we can be very sure that everolimus's PFS is around that number. We also knew that half of targeted patients was enrolled before april 2014, and all before July 2014. Also, we knew they at least have not reached 69% PFS events before March 2015. What do all these mean if you combine them together? We have a very very high probability to beat against 5.x months.
Add more insult to your dismay: since we are fighting against approved drugs, we will dominate their market after approval. Not a me-too.
I see either you are confused or try to mislead other people.
1&2.Yes, these patients were receiving some therapies(exception: Everolimus).
3. Since placebo can only last 2 months, I really doubt the randomization and dosing may take at least 4 weeks.
It's sad that Cabo is not a magic drug that can cure cancers, most of metastatic patients will die of RCC.
But, most importantly, METEOR is not going to test if cabo a magic cure so most patients will recover. None of the trials is testing that -- it's a sad but true statement. METEOR is going to test if Cabo can delay progression longer than Everolimus can do. That's why this test is NOT set up to fail.
It may not be appropriate, but let's say: It's like to test if you can run faster than one of other guys in forest, not to test if you can outrun a bear. Got it?
I asked my crystal ball: IF everolimus' median PFS is 5 months and trigger had been reached on 4/1/2015, what do we expect from cabo? It tells me: 12.
disclaimer: my crystal simulation also assume: 1/1 to 4/1, random enrollment to 50% and started immediately to dose, 4/1 to 7/1, 50%.
It all depends how well the everolimus is doing over expectation. I tried 183 days for its median, and we are still very good against it. I don't think PFS is a problem.
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?
FYI, sorafenib, sunitinib, axitinib, pazopanib and tivozanib are not antibodies. You can easily tell that from the names -nib. Ever heard of -mab? Of the approved drugs for RCC, only bevacizumab(avastin) is antibody. And it is for metastatic. So you can assume most of our patients didn't take antibody.
Somebody here claimed you were an ex-employee, I really doubt it.
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.
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.
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.
“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."
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.
because we spend money on MMM to travel and talk...and most important: expensive hair stylist.