Replies to post #44964 on Biotech Values

[p3analyze]

JB, Scher asked a trick question and implied the frozen provenge killed patients. Data said otherwise, as David pointed out, those who received frozen provenge lived longer than those who didn't. I guess that is not sufficient to answer the trick question, and you jumped on it.

While the decision to receive frozen provenge may be confounded with survival, there is no evidence that it did any harm, certainly not by the overall nomogram predicted survival for the placebo arm, or the fact that placebo arm performed as well as the taxotere arm in Tx327 study.

If you were Maha Hussain, you would have accused me of cross-trial comparison. Which is fine, now consider this. You said "men did not cross over could be because they were at a worse point in their disease progression and did not have the physical or mental capacity to try yet another experimental procedure". Continuing on that line of logic, those who chose taxotere over frozen provenge would have to be better off than those who did not, because we all know taxotere is more toxic and patients would have to be really tough physically before an oncologist wants to risk the side effects. Then explain to me how come those chemo only placebo had a worse survival than those who crossed over to frozen provenge if it were harmful and it got in the way of the life saving taxotere?

From
http://investor.dendreon.com/ReleaseDetail.cfm?ReleaseID=218144&Header=News
See
The median survival was 25.7 months for patients who received APC8015F followed by docetaxel. In contrast, the median survival was 20.2 months for patients who received placebo only and subsequent treatment with docetaxel, a 14.3 month difference compared to 34.5 month median survival seen in the patients who received initial treatment with PROVENGE followed by docetaxel

lest me forget- shame on you jellybean.

[AlpineBV_Miller]

You very well might be right. The fact is Howard suggests that guys who got frozen Provenge could have done worse than guys who did not get that. Fact #1 is he knows that is not true because he's seen that data presented.

Fact #2 is that you could have 10,000 patients in this trial and the problem you suggest (guys who don't rollover could do so for some other reason, probably related to health which makes them less likely to survive longer anyway) and you still wouldn't know.

Fact #3 is this is not a problem peculiar to the Provenge trial. The fact the guys who did no rollover did worse than guys who did is probably true in almost any rollover trial where the study agent is truly active.

Fact #4 is the control arm of the Provenge trial (21.4 months) was comparable to the asymptomatic data from the Tax-327 trial (q3w 23, Q1w 21.1, Mito 19.8) and comparable to that predicted by the Halabi nomogram (20.1 if memory serves). All this data Howard has seen because he was sitting feet away from me when it was presented.