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Re: Crusader post# 5906

Wednesday, 03/15/2017 2:17:38 PM

Wednesday, March 15, 2017 2:17:38 PM

Post# of 8169
Of course it is not a 'comprehensive' measure. No parameter alone, be it ORR of PFS is a comprehensive measure.
But ORR plus duration of response is what the FDA and potential pharma partners are looking at and other MM drugs set a high bar with their >50% ORR in this setting.

"Generally, the FDA has defined ORR as the sum of partial responses plus complete responses. When defined in this manner, ORR is a direct
measure of drug antitumor activity,
which can be evaluated in a single-arm study. Stable disease should not be a component of ORR."

This trial is currently at an ORR of 0%. Based on recent approvals, the FDA has accepted RR >28% for approval.

I'm not bashing here, just don't agree with SoW's blind optimism. Prefer to look at data...

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