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Re: iwfal post# 142471

Wednesday, 05/23/2012 9:32:48 PM

Wednesday, May 23, 2012 9:32:48 PM

Post# of 257406
I used a little bit of hyperbole, but I think the point is clear. Obviously CLDX doesnt/didnt have the cash/resources to run this the way it should have been, but its a good proof of concept study. It's randomized active-controlled data, which more than we can say about most data out there.

Agree with you that ORR is a poor endpoint. Actually Ixempra's Phase 2 trial illustrated this very point. Their single-arm Phase 2 trial in heavily pre-treated(prior A/T/C) breast cancer patients, IRF-assessed ORR was 11.5% but the investigator-assessed ORR was 18.3%, which is a 59% difference. Dr. Vahdat does disagree with on the ORR to PFS point, at least in this setting. Remember the PFS data they presented were not mature.

On your last point about the population size for the drug, I think it's much too early to say where CDX-011 could fit. This is the last-line setting, so I imagine if tested much earlier or in combo, we would be seeing drastically higher responses.

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