In my layman Sunday afternoon quarterback opinion,
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Posted On: 01/09/2022 3:02:13 PM
In my layman Sunday afternoon quarterback opinion, it's good to gather information with the three different protocols for potentially three or more different cancer indications, to see where the most promising signals are for further trials.
Broadest application is basket of anything with Mets and CCR5 overexpression, but that is the hardest to show efficacy, since there is no historical control group. I think low chance of BTD for basket at this point.
First line for mTNBC was good to run trial, since need is great and preclinical data were strong. Just saying that we can't compare straight up against Trodelvy since they were third line, where outcomes are expected to be worse. To find appropriate control group, need to look at first line carboplatin alone since we combine LL with carboplatin in our trial. I'm not sure how many patients we need for BTD for that indication, but I think we need to see the numbers for those 12, and we need more data. But yes BTD is achievable based on numbers seen so far.
The thing about low CTCs at baseline having better results with other drugs is a big confounder for us too.
For compassionate use, comparison with Trodelvy seems appropriate if we can show improvement as third line therapy. Again, I think need separate numbers, and more data. But BTD achievable for that indication.
I just think combining different mTNBC populations makes it very difficult for FDA to evaluate if LL is any better than SOC or recently approved drugs. What should LL be compared against?
Broadest application is basket of anything with Mets and CCR5 overexpression, but that is the hardest to show efficacy, since there is no historical control group. I think low chance of BTD for basket at this point.
First line for mTNBC was good to run trial, since need is great and preclinical data were strong. Just saying that we can't compare straight up against Trodelvy since they were third line, where outcomes are expected to be worse. To find appropriate control group, need to look at first line carboplatin alone since we combine LL with carboplatin in our trial. I'm not sure how many patients we need for BTD for that indication, but I think we need to see the numbers for those 12, and we need more data. But yes BTD is achievable based on numbers seen so far.
The thing about low CTCs at baseline having better results with other drugs is a big confounder for us too.
For compassionate use, comparison with Trodelvy seems appropriate if we can show improvement as third line therapy. Again, I think need separate numbers, and more data. But BTD achievable for that indication.
I just think combining different mTNBC populations makes it very difficult for FDA to evaluate if LL is any better than SOC or recently approved drugs. What should LL be compared against?
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