Biotech Values

[iwfal]

Ipilimumab -

Did y'all come to any conclusion whether the ipi label would be limited to HLA-2+ patients (51% of the market) due to the fact these were the only patients allowed in the trial?

I don't think it was discussed on the board - but realistically I don't see how that restriction would not be part of approval since:

a) HLA-2 status is known to be a factor in melanoma survival

b) HLA-2 is an immune system effector and the MOA of ipi is unambiguously immune based.

That said, I have been unable to track down the particular language/enrollment-restriction that is used in the clinical trials site. It doesn't call for HLA-2+ status, instead it calls for "HLA-A*0201 positive". Is A*201 a particular subtype of HLA-2? If so that would be a further restriction on the label. But not yet successful in decoding A*201.