Thursday, June 06, 2019 8:40:23 AM
I don't disagree that cross-trial comparisons are fraught with uncertainties.
But industry-watchers, analysts, regulators, HTA's, patient advocacy groups, message board chatterers, will all be doing it explicitly or otherwise, when this is unblinded. And if BMY release interim data from Checkmate-548, similar comparisons will be made. (Why didn't the FDA saddle that trial with a crossover?!)
On the info arm; the original definitions they employed were double rapid progressors and single rapid progressors.
The double rapid progressors (progression confirmed by a second scan) clearly were rapid progressors and I believe are all deceased.
But the single rapid progressors only had apparent signs of disease progression at one of the two timepoints,
These became known as the 'indeterminate' (not indeterminant)group.
Now I've completely forgotten what your premise is on this.
But the question for me is; is chemorad pseudo-progression a positive prognostic for survival?
Well, I'm not sure. Some of chemorad pseudo-progression is actually radiation necrosis. Does presence of radiation necrosis inform outcome at all? I have doubts about that.
You can argue this info arm issue any which way, to suit one's view.
I could, for example, point out that in EF-14, they waited nearly a month longer before randomization, to let in confirmed pseudo-progressors.
So all in all, I don't draw too much from indeterminate outcomes, as it might relate to trial outcome.
But the SNO data remains very promising at least to me.
And the long tail will be further elucidated after unblinding.
But industry-watchers, analysts, regulators, HTA's, patient advocacy groups, message board chatterers, will all be doing it explicitly or otherwise, when this is unblinded. And if BMY release interim data from Checkmate-548, similar comparisons will be made. (Why didn't the FDA saddle that trial with a crossover?!)
On the info arm; the original definitions they employed were double rapid progressors and single rapid progressors.
The double rapid progressors (progression confirmed by a second scan) clearly were rapid progressors and I believe are all deceased.
But the single rapid progressors only had apparent signs of disease progression at one of the two timepoints,
These became known as the 'indeterminate' (not indeterminant)group.
Now I've completely forgotten what your premise is on this.
But the question for me is; is chemorad pseudo-progression a positive prognostic for survival?
Well, I'm not sure. Some of chemorad pseudo-progression is actually radiation necrosis. Does presence of radiation necrosis inform outcome at all? I have doubts about that.
You can argue this info arm issue any which way, to suit one's view.
I could, for example, point out that in EF-14, they waited nearly a month longer before randomization, to let in confirmed pseudo-progressors.
So all in all, I don't draw too much from indeterminate outcomes, as it might relate to trial outcome.
But the SNO data remains very promising at least to me.
And the long tail will be further elucidated after unblinding.
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