and the bad news just keeps rolling. Not good enough to have this trial ended for 'futility' (a great word to describe our investment in arqule btw) but they had to end it for 'safety' just to really nail it. we are now the proud owners of an option on a biotech stock...as risky as it gets. And in the middle of it all, CITI upgrades ARQL to buy...wonders never cease.
This trial was dead for more than 2 months.
ATTENTION and Marquee had almost the same designs. Marquee has failed making no sense to continue ATTENTION.
Since there was no PhII in NSCLC in Asian pts, it is necessary to run PhII first before doing PhIII.
So there is no bad news about the ATTENTION discontinuation. It had to be discontinued!
At the same time, ARQL PhII in NSCLC KRAS-mutant pts was changed in Sept from double-blind to open-label and with c-MET status measurements and analysis.
- KRAS-mutant pts are 25% of all NSCLC pts. The open-label trial will provide REAL data for Tiva efficacy in NSCLC. The results are due in May-June 2013.
- Double-blinded PhII are done only for registration purposes after being 95% sure that it will be successful.
Otherwise, it was a major ARQL management screw-up since Tiva efficacy in NSCLC and its subgroups is still unknown.
I hope Pucci learned a good lesson from the MARQUEE failure.
The ATTENTION news sounds bad but it is not since it was 100% expected.
Kyowa Hakko looks incompetent in conducting clinical trial. I hope they return their Tiva rights back to ArQule.
Finally, c-MET inhibitor drugs are new science frontiers. So, there will be ups and downs.
Erbitux was a failure for almost 5-7 years before it became a $2B-drug. LLY gave Erbitux back to the inventor for free stating it was totally useless and, 8 years later, bought it once again for $6.5B.
ImClone & BMY failed to run good clinical trials but Merck KGaA has done it right.
Pharma - as always, thank you for insight. I hadn't seen the change on the ph2...I'm interpreting your comment re 'cmet status measurement and analysis'...to mean that the change to open label enables them to more quickly identify if Tiva is working for cmet+ pop...correct interpretation?? The announcement this morning was to be expected I guess but at the same time there is the additional negative that recommendation to be stopped came from safety review board...my interpretation is that they did conclude a link between Tiva and ILD occurrence. I do agree: both Arql and Kyowa screwed up with these ph3 trials...to be charitable, that's with benefit of hindsight but still from the layman's perspective: you have a drug that you're promoting as a cmet inhibitor, why the heck wouldn't that then be focus of your trial?? Your mention of erbitux very interesting...what a rollcoaster that was with Karl Icahn taking advantage of its several ups and downs not to mention Martha doing prison time....she should have just held on to the stock...