1. Would a much, much larger basket trial (using L
Post# of 157598
Quote:
1. Would a much, much larger basket trial (using LL and a checkpoint inhibitor) of many different types measuring PD-L1 escalation as an endpoint and another endpoint for improved survival using LL and SOC for each indication make any sense so that we could win approval for many different indications at once? Or would that trial not be "powered" with enough patients for each indication?
Basket studies are for proof of concept and we couldn't get approval based on the results from that.
Quote:
2. Or since we would be proving MOA with data in the mCRC trial would that be enough to allow LL to be used wherever PD-L1 escalation is needed in order to use a checkpoint inhibitor?
No, there are enough differences between cancers we'd have to do standalone trials in each cancer indication. However, proving out the PD-L1 activation and the combination of leronlimab and a PD-L1 inhibitor would mean a faster response for approval in other cancer trials and maybe even some NIH support. Although with the slash and burn budget tactics going on right now I wouldn't count on governmental support until 2029.
Quote:
I guess what I'm really wondering is what do you think is the fastest way to approval or widespread usage on all of the other indications other than CRC for LL (and that can use a checkpoint inhibitor once escalation of PD-L1 is shown)?
The fastest way is approval in any major indication and using the revenues to launch multiple trials.

