funny, this stock has me baffled. Every time I think Its gonna soar it tanks. This should give confidence for upgrades, especially with all the near term potential. Of course, things usually work in reverse with this thing (my average is $3.90 ;( ). I anticipate plus .25 today, at least, even without any upgrade...jmho
Depends on patient population, luck/by chance. Maybe some immunotherapys as prior investigational therapy change the outcome...
Another factor is prior therapy. PFS with prior sorafenib in p3 was 5.9 months, with sunitinib as prior therapy it was only slightly above 4 months.
With a 600 market cap and great results exel should easily shoot to 5 bucks in near future this stock is a gem just buy and hold and u will be rewarded I'd never short at this point
This is a great question, and I think that the answer lies under the heading of "other outcomes"...and is one of the reasons I believe there is so much interest in the ECOG/ACRIN E1512 trial. These two trials share some commonality in that both are gathering data to correlate MET expression and response to therapy to survival benefit - both PFS and OS. These data could effectively turn Cabo into a biomarker-driven treatment resource by defining the most responsive patient group. I am cautiously optimistic that we are closing in on a genomic assay driven application for cabozantinib that has not yet been aptly described in the literature. Just an informed hunch at this juncture, but ASCO should prove revealing...
The median patient of the 375 patients was enrolled in april 2014, the last patient in june 2014. Means 12 months and 10 months from now.
Data from the everolimus p3 indicates a 4,9 month overall survival. This phase 3 further showed that after 10months 25% had not progressed and after 12months 10% had not progressed.
Cabozantinib phase 2 showed a 12.8 months pfs. Let's assume this 12.8 months doesn't hold up because a phase 2 often overestimates PFS and let's calculate with 11 months.
Lets calculate based on the past data and this assumption how many patients progressed assuming something around little over 11 months.
How many progressed so far: everolimus 155+cabozantinib 94 = 249. Very close to the target.
But caution,everolimus could have done much better and cabozantinib much worse. We just have to wait.
FDA has granted Priority Review to the NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 11, 2015. A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
The PDUFA action date is given, Priority Review has been granted and the results are close to overwhelming hence I expect a decision before PDUFA action date. I would bet for a decision before August, and I hope for one being made in June.
However the European agency is a lame duck as usual bec the process had been started earlier (9/2014) but more time is being needed to reach a decision, maybe it will last until 4q2015.
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?
METEOR is the company’s phase 3 pivotal trial of cabozantinib in mRCC. Enrollment was completed in November 2014, and the protocol specifies that the analysis of the primary endpoint, progression-free survival (PFS), will be conducted once 259 events have occurred among the first 375 patients enrolled. Exelixis previously stated that top-line results from METEOR were anticipated to be available in the second quarter of 2015; however, because the rate at which events associated with the primary endpoint
of PFS are accumulating has slowed, the company now anticipates top-line results will be available at the end of the second quarter or early in the third quarter of this year.
"...trial would have been stopped..."
I've considered this scenario at length, and concluded that Cabo's optimal commercial potential lies in distinguishing itself from other TKIs. In mRCC, that means it'll have to find a competitive spot in the post-sorafenib treatment algorithm with Axitinib, pazopanib, and sunitinib. Doesn't this line of thinking preclude early trial shutdown for presumed efficacy?...or am I missing something?
The primary endpoint analysis of median PFS will be conducted once 259 events have occurred among the first 375 patients enrolled.
Read between the lines. The clue is from this afternoon's call is sending the message on what could happen after meteor success. I do not speculate a buy out, but the obvious is right before our eyes.
I agree, EXEL does not need any offering if Meteor results will be successful. Money will be flowing.