Monday, July 25, 2016 9:43:10 AM
the therapies mentioned by Vinmantoo, such as Xtandi and Tamoxifen, however, are hormonal treatments (not Mabs) often used in breast and prostate cancer.
As the use of these hormones are Standard of Care for various types of these cancers, how do you expect to prove that these adjunctive hormonal therapies make a difference with I/O 1.0 downstream inhibitors?
How do you separate out the effect of the adjunctive hormonal therapy from the actual chemo/radiation given for the breast or prostate cancer?
The answer is you can't. You would have to run trials with some patients receiving chemo only + anti-XYZ downstreamers and the other arm receiving chemo + anti-XYZ + adjunctive hormonal therapy, to see if the adjunctive hormonal therapy really made a difference.
But that's not the way those trials you cited are designed. And they CAN'T be designed that way, because that would entail a departure from SOC, leaving off the adjunctive hormonal therapy.
You can't do that.
You can't run a trial off SOC to prove adjunctive hormonal therapy synergizes with anti-XYZers. You can't.
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