The bull case is that they have an SPA and easily met the criteria in that SPA. Further, the median PFS improvement clearly understates the actual benefit given the median happened to be on a scallop on the K-M curves where the two curves were relatively close - the improvement is quite a bit better at say both 45% and 55%. Furthermore there is really nothing available for sarcoma and there is a reasonable chance that the drug will end up being used successfully in combination therapy (both with existing drugs and with others in development).
The bear case is that the FDA can tear up an SPA if they want, and the OS curves aren't that great. Further there is no quality of life data (for reasons I don't understand). And there seems to be no identifiable subgroup where it works great. So an AC could balk.
In terms of commercial success, I really think this partly depends on whether they can find some way to break the AKT/mTOR inhibition feedback loop. If so, this could still be a big drug.
Merck seems to be proceeding with studies - for example there was this new trial posted last week (along with a PK study in Chinese patients in China and a monotherapy pediatric trial).
Dalotuzamab is an antibody against IGFR1. Here is the rationale:
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