Seems to be OS events.
Based on available clinical trial data, the primary endpoint assumes a median PFS of 5 months for the everolimus arm and 7.5 months for cabozantinib arm. This provides for a hazard ratio (HR) of 0.67 and 90% power and requires 259 PFS events among the first 375 patients randomized. The secondary endpoint assumes a median OS of 15 months for the everolimus arm and 20 months for the cabozantinib arm. This provides for a HR of 0.75 and 80% power and requires 413 events.
The end of enrollment for first 375 patient was June2014, the mid of enrollment for them was around April2014. Primary analysis will be on this group of patients. 70% events of this group will trigger analysis. 9 months after May2014 seems long enough if 5/7.5 months estimate holds true.
"The 375th patient was enrolled in June 2014 and the median patient in this group was enrolled in early Q2 2014."
All of 375 patients passed the 5 months mark, About half is at 7.5 months mark. 70% events are not too far away. Draw two bell curves with median at 5 and 7.5 on one sheet, estimate when is the 30% area of the combined tail, you will have a feeling how long you will be watching the paint dry......
Why thumb down me? This might not be a precise estimate, but very close. My guesstimate is about 45 of the 70 cents has been reached. Since PFS is the primary end point, the analysis may take longer than interim analysis after 70 being reached.
What's your estimate?
One sad but very possible conclusion is that: if 5/7.5 holds true, this holiday season (from thanksgiving to new year) doctors will break biggest number of progression news to our trial patients.
Let's pray for them and their families.
Man, you can view that population as two group. One is with 375 patient. When 70% PFS events is reached, this group will be unblinded. Got it? We are not waiting for whole population OS event trigger, which may be at year 2016.
7.5 months from when? In this study, we might very likely pass 7.5 line. Remember, we dose the patients on a rolling base, enroll then dose. If a trial pre-set a 70% point, and the drug can separate patients in a big gap, let's say, 5 months vs 20 months, trigger will happen long before 20 months after last enrollment.
Seems you still cannot appreciate the beauty of PFS approvable end point. PFS result came out long before OS, cabo got approved long before OS result. The PFS result was not interfered by patients' switching to other drugs after progression.
12 weeks after last enrollment first dose?
MMM was not very transparent on COMET II enrollment. They actually didn't ACTUALLY update clinicaltrials after 2014_04_18 while COMET-1 kept updating. And then suddenly call for stopping enrollment of comet-2 with comet-1 result. We can smell but we don't know what it is.
Maybe a letter from FDA that you have to do at least three or more branches comparative trial against current newest drugs to show non-inferiority?
Do we want to do that or go with other PFS approvable low hanging fruits?
extrapolation of COMET-1's result is promising. Since RCC is all about PFS, Comet-1's PFS is excellent. So did MTC's PFS. RCC will too. HCC is tough.
MMM had deals with GS and other financial companies. Every time he signed a deal with those companies, EXEL crashed.
When will be METEOR cut off date if we assume all the assumptions told by the company?
Half enrollment by the beginning of April 2013, all enrollment by end of June 2013, 50% / 50% grouping, 1st group median event time 5 months, 2nd group median event time 7.5 months, cut-off on 70% events.
Mid May plus 8.5 mos will be off by what margin?
Why do we want to spend our money on MMM for him to talk?
If he gets an award for "Best hair style among biotech CEOs", the bold man of one big company will buy out EXEL due to jealousy?