I just read through the slide deck presented at ASCO, and they did show the change in biomarkers for both bisphosphonate-naive and bisphosphonate-treated patients. It would have been nice if they did the same for the effects on bone pain and narcotic use (even though these data were collected retrospectively).
Well the main question is whether the bone scan results are legitimate or somehow factitious. That's going to be quickly resolved by MRI and CAT scan follow-up. If they are proven to be legitimate, then why wouldn't the FDA accept scan results (with MRI backup) plus pain reduction as an endpoint?
People are also overlooking that the drug had a significant impact on some tumor sizes, even with patients that had failed abiraterone/MDV3100 and docetaxel. Pretty dramatic results for this late-stage set of patients in my view.
Of course there is the PSA weirdness. That's certainly going to make folks feel uncomfortable until it is explained.
My eventual hope is that the combination of Aveo's two lead drugs will produce the same (or better) results with much lower toxicity. But that's a good few years off still.
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