Biotech Values

[iwfal]

Interesting thesis for MB discussion - Having now read the reviews of a large number of targeted therapies there seem to be a lot of examples of them having great efficacy in one subgroup, but actually killing patients in the remainder of the population. The best example I have found so far is MetMab which actually hurts the non-targeted pop by almost as much as it helps the targeted population:

In high-met patients: PFS HR=0.53, OS HR=0.37

In low-met patients: PFS HR=1.82, OS HR=1.73


Interesting questions:

1) Are these treatments really spectacular - or is their benefit *only* that they allow identification of targeted populations?

2) How does the FDA treat these drugs - e.g. MetMab is having to run a ph iii despite spectacular results in a ph ii pre-defined subgroup, yet Criz and PLX4032 got lickety split approval.

3) Why do they actually reduce PFS in the non-targetted population? I can understand it reducing the OS in the non-targeted pop by general toxicity to the patient - but how does it speed up the tumor growth?