Replies to post #149707 on Biotech Values

[mcbio]

The CEO mentioned that the 375-pts event took place sometimes in mid July 2012.

"The mOS for the erlotinib control arm is assumed to be 7 months."

The PhII placebo-arm had just 6% of KRAS-mutant pts. These pts have just 2.5 months mOS in the 1st-line pts. There are ~25% of KRAS-mutant pts in a general NSCLC population. ARQL mentioned that PhIII pts population would model the "real life" or mKRAS is expected to be ~ 25%.

MARQUEE's much higher mKRAS population could bring the erlotinib control arm mOS to under 6 month.

My "on a top of an envelop" calculations for the 7-months the erlotinib control arm mOS would bring the the 375-pts event to mid August for the 2-months control/drug arms mOS separation. The 6-months erlotinib control arm mOS would bring the the 375-pts event to mid July for the same 2-months control/drug arms mOS separation.

So, do you think there is enough mKRAS in the trial, to go along with any other factors, that would cause you to not take the interim being triggered at this stage as a bearish sign?

It is very puzzling to me why MARQUUE trial has mEGFR pts population.

Are you implying this is a bearish sign as it relates to ultimate chances of the trial's success?

[jq1234]

I agree ph2 trial had bias toward placebo arm. That to me along with crossover provided important margin of error. As of including mEGFR, the trial population is based on histology non-squamous, you really can't further slice and dice it by excluding molecular type where erlotinib works really well. That's called bias. OS for wtEGFR is key secondary endpoint.

[turtlepower]

The PhII placebo-arm had just 6% of KRAS-mutant pts. These pts have just 2.5 months mOS in the 1st-line pts.

2.5M sounds a bit low. In the ARRY P2 trial 2nd line KRAS mutant patients had a mOS of 5.2 months.
http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArticle&ID=1702337&highlight=

[Summer2762]

MARQUEE's much higher mKRAS population could bring the erlotinib control arm mOS to under 6 month

Much higher than which trial? ARQL's P2 trial? Or other non-squamous (2ndline?) NSCLC trials?

[caravon]

Giving one more look at the Tivantinib PhII trial data, it becomes quite obvious to me that the c-MET+ biomarker overwhelmingly superior to all other biomarkers (histology, KRAS, and EGFR) in predicting Tivantinib benefits in treating NSCLC pts even in specific subgroups such as KRAS and EGFR wild/mutant pts.