Biotech Values

[DewDiligence]

BMY/Ipilimumab: After reading the article you linked to, I’m comfortable saying that the cited concerns about Ipi from a medical standpoint are a red herring. The notion that the inclusion of gp100 in the phase-3 trial makes it difficult to assess Ipi’s true efficacy is entirely groundless, IMO, and BMY did a fine job of explaining why on its ASCO webcast a few days ago. If you’re interested in BMY’s argument but you don’t have time to listen to the hour-long ASCO webcast, you can glean most of what you need to know by viewing webcast slide #11 (http://www.bms.com/Documents/investors/ASCO_BMS_06_07_2010.pdf ), which plots the OS Kaplan-Meier curves from the three trial arms. From these plots, there are two main observations to be made:

• The K-M curves for the Ipi+gp100 and Ipi-monotherapy arms are almost indistinguishable from zero to two years on the x-axis, and they vary very little beyond 2 years. Moreover, at no point do these curves have any kinks or oddities that might suggest a deleterious effect from gp100 in the combination arm.

• The K-M curve for the gp100 monotherapy arm looks much like what has been reported in the peer-reviewed literature for placebo treatment in this indication.

Where the Ipi BLA in second-line metastatic melanoma figures to become interesting is not in the assessment of Ipi’s efficacy per se, but rather in how the FDA reacts to BMY’s ploy of seeking approval for Ipi monotherapy based on a secondary analysis in the phase-3 trial (#msg-51171110).

In this regard, the Ipi BLA has a lot in common with DNDN’s original Provenge submission that resulted in the FDA’s requesting more data. I would not be unduly surprised if the FDA ends up asking BMY to run a new trial testing Ipi monotherapy vs some comparator so the FDA can avoid having to approve Ipi monotherapy based on a secondary analysis.