Few prelim thoughts on this trial (from quick read) #ASH21 1. It is not a 'second line' trial, it is a trial in the worst subset of second line pts & cannot extrapolate beyond
Primary refractory & relapse <12 mo
(TBH, a lot of people doing this already)
As such, it should not generalize to relapse > 12 months
2. That said, for those included, axi-cel seems preferable to chemo then auto; I am not surprised this is true in the most chemo insensitive biology. But a few more thoughts
3. This is Wrong, you are not supposed to do this ππ
Standard practice is to take these pts to CAR-T if needed in the control arm; thus, you must compare routine, upfront CAR-T to using CAR-T as salvage when indicated and standard of care.
And you don't adjust for it
You want to prove that routine, upfront CAR T is superior to salvage CAR-T
That's literally the Q: one of sequence.
Control arm attrition is terrible, which tells you this is the worst of the worst DLBCL (and the trial does not extrapolate to all second line)
This is a silly way to show the data.
Better to break the <12 month relapse into 1-3, 3-6, 6-9, and 9 - 12.
The idea would be that as relapse occurs later, auto remains superior
Even with the deck stacked in favor of axi-cel
Would be less impressive with indication drift & better use of CAR-T post protocol for control arm
Overall: ok study, but not really as impactful as I had thought.
The population is a narrow one and very chemo-insensitive. This supports CAR-T second line for such pts, as many were already doing.
Worry: there will be indication drift to all second line
... many of these people who are losing their jobs right now risk their own personal safety to work in the hospital before there was a vaccine. When you needed them.
These people don't disappear from America either, and their fate is tied to all our fate.
Pressuring people to get vaccinated will increase vaccination rate some fraction and that will provide some marginal extra protection to people who've already chosen to be vaccinated, but it will also lead to firings and that will provide negative countervailing results..
My NEW op-ed is out in @usnews!
Mandating 12-18 year old kids get 2 doses of COVID19 vaccine & throwing them out of school if they don't is one of the most regressive, dangerous, and misguided policies in recent years, and I condemn it