(Total Views: 312)
Posted On: 10/02/2025 6:30:22 PM
Post# of 157631
Thanks for the reply. Really appreciate your depth of knowledge on all things LL.
For the current trial, I know we need to do first things first, and everything depends on PD-L1 escalation data and improved survival. But looking ahead, after escalation data proving MOA and a mCRC trial that is successful and attains regulatory approval, I'm wondering what is the best way to move forward on other indications.
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?
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?
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)?
Science is not my area of expertise, so any observations you may have would be appreciated.
Thanks, Ramjet
KOKO&SLLH
For the current trial, I know we need to do first things first, and everything depends on PD-L1 escalation data and improved survival. But looking ahead, after escalation data proving MOA and a mCRC trial that is successful and attains regulatory approval, I'm wondering what is the best way to move forward on other indications.
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?
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?
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)?
Science is not my area of expertise, so any observations you may have would be appreciated.
Thanks, Ramjet
KOKO&SLLH
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