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jbog

01/25/07 5:53 PM

#3254 RE: bio_guyo #3253

bio,

You got it right. Also how long do you think it would take Amgen to enroll a trial?? A zillion years.
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p3analyze

01/25/07 5:59 PM

#3257 RE: bio_guyo #3253

12-week response rate was not a standard endpoint used in oncology - therefore how predictive it will be of PFS and OS will be unknown.

Having said that, the added toxicity of triple may have shortened the treatment duration - and thus lower the chance for success in the future.

This is a medical affairs trial - so may not be respresentative of those in clinical development - which has trial program that essentially mimic the EPIC, the Crystal etc. Third-line rr seem to be rather comparable between the two drugs.

But the short-term threat is alleviated
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upwestside

01/25/07 6:36 PM

#3258 RE: bio_guyo #3253

fair enough and you make good points. maybe you can solve another dilemma for me: trial 025 met its primary endpoint against (what i understand to be) a difficult-to-beat BSC standard. form reading this board, BSC is supposed to be superior metric to PFS or OS (i dont remember which one) which was the endpoint in the pani mono trial. i know pani beat with very high stat sig but isnt demonstrating superiority to BSC a bigger accomplishment? if so, how could vecti take sales away from erb in mono setting? if BSC is not the metric i thought it was, then my question is how could erb demonstrate superiority to erb in this setting?

thanks.