the data is mostly as expected. JL is very conservative. i told my friend who invested to expected up to 20 patients at most, majority with significant circulating tumor cell reduction, majority with significant PD-L1 increase and no ORR data this time. i got the 1st 2 right the 2nd half wrong.
they kicked the can on PD-L1 and they mentioned but essentially masked the ORR. so not quite as expected, but being "conservative" in approach and "limited data" due to the circumstances (need for an early data cutoff) is what most of us did expect i believe. we all knew the cutoff date would restrict the N.
and we also knew that the N would likely be skewed towards low-dose patients. really, the 350mg data doesnt matter much, except as a comparison that will very strongly validate the well-known dose dependency of leronlimab, which is very important to have and to validate for the fda in each indication. that mission will certainly be accomplished.
they didnt break it down 350 vs 700, but that make a lot of sense. only 9 or 32 enrolled at the time of the data cutoff for the poster were 700, and of the 19 with 2 week data the N for the 700 would obviously be less than 9. and any time you report on lets say a cohort of 5, and try and shine a light on that, you open the door for negative analysis. JL is an industry veteran and he is reporting the data carefully.
the ORR wasnt even referred to as ORR but rather "available RECIST data". and actually, with a cutoff date that appears to have been in january (2 week data on patients enrolled thru december), referring to it as "available RECIST data" rather than ORR might simply mean that they only have 1 scan and not a confirmatory scan yet for many of the 13. masking the data by stating 9/13 stable or shrinkage (and not including a % shrinkage) supports the theory that its preliminary and not complete RECIST data. and it also might indicate a desire to wait on the stronger data from more 700mg patients getting scans before sharing specifics.
nothing wrong with this data presentation. its just early per the cutoff date, so there isn't too much there. a nice teaser.
the real interim data comes next month.
they kicked the can on PD-L1 and they mentioned but essentially masked the ORR. so not quite as expected, but being "conservative" in approach and "limited data" due to the circumstances (need for an early data cutoff) is what most of us did expect i believe. we all knew the cutoff date would restrict the N.
and we also knew that the N would likely be skewed towards low-dose patients. really, the 350mg data doesnt matter much, except as a comparison that will very strongly validate the well-known dose dependency of leronlimab, which is very important to have and to validate for the fda in each indication. that mission will certainly be accomplished.
they didnt break it down 350 vs 700, but that make a lot of sense. only 9 or 32 enrolled at the time of the data cutoff for the poster were 700, and of the 19 with 2 week data the N for the 700 would obviously be less than 9. and any time you report on lets say a cohort of 5, and try and shine a light on that, you open the door for negative analysis. JL is an industry veteran and he is reporting the data carefully.
the ORR wasnt even referred to as ORR but rather "available RECIST data". and actually, with a cutoff date that appears to have been in january (2 week data on patients enrolled thru december), referring to it as "available RECIST data" rather than ORR might simply mean that they only have 1 scan and not a confirmatory scan yet for many of the 13. masking the data by stating 9/13 stable or shrinkage (and not including a % shrinkage) supports the theory that its preliminary and not complete RECIST data. and it also might indicate a desire to wait on the stronger data from more 700mg patients getting scans before sharing specifics.
nothing wrong with this data presentation. its just early per the cutoff date, so there isn't too much there. a nice teaser.
the real interim data comes next month.
9
9
