why only 5 in the LL-only?? What do you mean by
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Posted On: 10/07/2024 2:41:56 AM
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why only 5 in the LL-only??
What do you mean by LL-only. With a cancer trial the FDA would not allow a leronlimab only arm. The first 5 at 350mg are a combo with TAS-102, bevacizumab and leronlimab to test for any drug interactions between the combo. Once safety is established then they'll start dosing the 700mg patients.
All 60 patients are in the three combo therapy. What the historical TAS-102/bevacizumab comparison p values is, is unknown. Looking at the protocol of the phase 3 TAS-102/bevacizumab trial there was a subgroup study for MSS. That those numbers were never released may be because the p values were not statistically significant. But the FDA would have those numbers and they are what will probably be used. It is a phase 2 trial so we do not need to have statistical significance to go on to a phase 3 we just have to show leronlimab adds decent benefit by comparison.
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