Morgan Stanley presentation.
* I wish Pucci kept his mouth shut since Schwartz had to translate and clarify the Pucci's presentation.
Pucci as a presenter is a liability instead of being an asset.
*Sounded positive about going with Ph3 in HCC monotherapy and expecting FDA to show some flexibility reviewing trial results as long as ITT pts numbers reach targets
* Apparently to cut cost, too many Ph3 NSCLC pts come from Europe. HR = 0.82 is a cut point for the interim analysis.
* There is no yet a clear-cut definition for c-Met+ pts
The .82 is the HR cut-off for the full trial. The goal, according to Dr. Schwartz is .75 HR with a p-value of 01. For the interim, the trial could be stopped if the HR is .67 and the p-value is .001. Even Dr. Schwartz doesn't believe that will happen. If the HR at the interim is over .9, the trial will be stopped for lack of efficacy.
ARQL would like an SPA with the FDA for the Phase III trial in HCC. This will be a monotherapy trial in 2nd line HCC. ARQL plans a 1st line trial with Nexavar.
Results from the Phase II in colorectal cancer should be available before the end of the year.
The halt to the Asian trial is still being investigated. There have been no cases of ILD in the Western trial. Final data on the Phase III in lung cancer will be presented in 1H13. Over 1000 patients have been enrolled.
Back to the numbers:
It is correct (after additional checking),
* The .82 is the HR cut-off for the full trial.
* The goal, according to Dr. Schwartz is .75 HR with a p-value of 01.
* For the interim, the trial could be stopped if the HR = .68 for high efficacy or over .93 for lack of efficacy.
* The number of pts with c-Met+ is not known at this time (just guesses and hopes for 50%+). Why?
* It appears that (according to Brian) ARQL went into Ph3 NSCLC with many assumptions instead of "going for the kill"
* ARQL would not have any problems with c-Met High pts
* The problems might come from c-Met Low and specifically from EGFR-mutant pts
* I expect the trial will go on to the end
Yes, no doubt about it, the hand-off yesterday was embarrasing. Paolo should not have started to answer if he was going to hand-off in the middle when he got to the 'technical' part. Also, whoever presented the day before said that the Kyowa gastric trial has not reported yet...maybe he's right but I thought it had and that it showed no benefit. Like every other biotech at this stage, we're either going to $2 or $12+ and I have no idea which. The issue causing the suspension in Asia seems like could be due to several causes but even if they do start re-recruiting, my guess is we wouldn't see a bump back up...we need pos+ mid-term marquee results.