Replies to post #97057 on Biotech Values

[genisi]

Back to your original subject, I believe it depends on the data from the phase III in 1st line study where HLA-A*0201+ was not an inclusion criteria, and whether this study will be required for approval.

[iwfal]

ipilimumab HLA-2

I believe the difference, in this specific instance, is just differing nomenclature.

If that is BMS intent it is, from your own cite, clearly a misuse of the technical terminology. The wikepedia cite makes in clear that HLA-A201 is one allele of HLA-A2. The most common, but still only one.

Overall the choices appear to be:

a) Clinical Trials is incorrect - and eligibility only required HLA-A2+ (of any allele).

b) Clinical Trials is correct - and so only some HLA-A2 alleles are elligible. But I don't know what percentage of HLA-A2 is HLA-A201. And note that in other ipi trials the eligibility criteria are VERY specific that only the 201 allele counts for eligibility.

http://clinicaltrials.gov/ct2/show/NCT00084656?term=ipilimumab+HLA&rank=3

HLA-A*0201 positive by DNA allele-specific polymerase chain reaction assay

I've seen ipi presentations at conferences use both notations and consistently describe each as present in ~50% of the population

Might they be saying that 50% of HLA-A2+ is HLA-A201? Not making the case - but noting one possible area where communication might be distorted.

Obviously it is true (as genisi noted) that if the DTIC trial comes in stat sig that this is all moot. But that trial seems to be perhaps 9+ months behind according to Clinical Trials. And no guarantee of success.