Replies to post #145239 on Biotech Values

[jq1234]

I don't think anyone can explain away the no OS benefit trend issue unless new trial result shows other wise. Read his contradictions:

Prior to vintafolide, no drug has demonstrated an improvement in either survival or delayed disease progression.

OK, if this is true, then why should the below matter?

The control arm received more post-study therapy than treatment arm

Plus, below is true to both PFS and OS, but only PFS benefit, no OS benefit trend (not asking stat significance here, just trend):

First, the study used a 2:1 randomiziation, so we had 100 patients in the treatment arm and only 49 in the control arm, so a much smaller sample for the ccntrol arm.

So the only point left is this, but no one knows whether this WAS affecting OS benefit:

and the control arm patients had a better prognosis than the treatment arm

[iwfal]

ECYT -

As reported we did not see an improvement in overall survival. However, as we pointed out, the study was not powered for OS analysis so no definitive conclusions can be drawn from these data.

Primary comment (assuming no cross-over on the principle that they would have trumpeted it as the reason for the OS results) - They published the OS HR for FR++ as 1.09. They did NOT publish the OS HR for FR+ and if it had been positive (e.g. under 0.8) I am sure they would have. That means the the OS HR was poor in both FR++ and FR+ despite having good PFS in both of groups. That seems a little too coincidental to me. I'd WAG the chances of the OS HR being found to be less than 0.85 for FR++ in the next randomized trial as less than 20%.