Biotech Values

[poorgradstudent]

Registration trials:

I think there are reasonable questions to ask about ARIA's rida trial. But more generally I guess I'm not totally clear on this point:

Tarceva in pancreatic cancer was in combination with Gemcitabine vs Gemcitabine alone, so it was against active treatment not placebo, the burden is different.

Why does it matter if the control arm was another drug or not? If it's a properly run controlled trial that doesn't deprive patients of suitable treatment (presumably the rida control arm is BSC), why should the agency think less of it? If it's the suitable trial for the stage of disease, then...? Tarceva did just fine getting on the market for lung cancer based on a trial versus BSC.

Both PFS and OS achieved stat significant here as well.

I guess. Although the OS advantage in the Tarceva pancreatic trial was 0.4 months, not any better than the PFS advantage. Being an OSIP investor at that time, I can tell you that the excitement over the pancreatic results was far from universal. In fact, the statistical significance of the survival analysis (p=0.028) wasn't much of a comfort.

I think the rida situation speaks more to the FDA's posture on the SPAs it grants, and what it wants to do with the PFS endpoint in general. Obviously the danger for rida is that it goes the way of satraplatin.


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The one glimmer of hope for rida in this trial is that their site analysis of PFS is a better surrogate of how the survival data may turn out than the central review data. At least under that consideration they get a few extra weeks of benefit