Biotech Values

[poorgradstudent]

"Can you please favor me with a reply regarding the major disticntion between surrogate endpoints ( aka:putative objective data?) and survival data (I removed long term)."

Surrogate endpoints were initially expected to be early indicators of an eventual survival benefit. However, the relationship has not been a simple one in oncology. In oncology trials, companies often look at tumour shrinkage (response rate) as a surrogate. However, an increase in response rate has not always translated into a survival benefit. Therefore, response rate is becoming a tough sell with the FDA, in my opinion.

As an investor, the major distinction is best exemplified by Iressa versus Tarceva. Nuff said.

It also presents itself, to some degree, in the general "perception" of Avastin versus Erbitux. In my opinion, Erbitux still has a bit of a weight on its shoulders from not having shown a survival benefit. Because of that, it will always be running against big brother (avastin, with survival benefit) trying to catch up.

The possible scenario developing for head and neck cancer with erbitux versus INGN's p53 adenovector may well resemble Avastin vs. Erbitux in colorectal cancer.

When survival data comes out, it's not a great position to be holding the competitor's (surrogate) bag.