Biotech Values

[DewDiligence]

BMY/Ipilimumab:

…it probably is an issue with alpha spend… If they spent all p=0.05 on the primary endpoint of ipi+gp100 vs gp100, there is no alpha to spend on the "any ipi" or "ipi monotherapy" analyses they will be asking for approval.

That’s just another way of saying that BMY is seeking approval based on a secondary analysis (Ipi monotherapy vs gp100). There is not a separate issue with respect to alpha spend as there would have been if the Ipi+gp100-vs-gp100 primary analysis had missed its p-value cutoff, thereby invalidating the secondary analysis.

This assumes, of course, that BMY will not be applying for a ipi + gp100 dual-approval label.

That’s correct—BMY’s application in the second-line setting will seek FDA approval only for Ipi as a monotherapy.