Ken, I tend to agree with Plotinus here. Worst-case scenario--if patients progress, they get an ICI. There may be a few people in the 350 mg cohort who actually get an ICI before people in the 700mg cohort get to the rollover portion of the trial! And the trial itself is short; it's not dependent on Overall Survival, and in 12 months they get rolled over. If we believe Dr Kasi, the 70% drop in ctDNA is really clinically significant. And don't discount the reports of improved quality of life. (And QOL is not just based on stories and anecdotes; patients take surveys regularly, and those reports of less pain from tumors, less fatigue, and going back to work are part of the trial record). So patients are getting REAL BENEFIT from this trial. Certainly better than SOC. Don't think otherwise. I think this is a very well designed, patient-friendly trial. And on top of this, the TNBC trial is testing the leronlimab/ICI combo as we speak.
Cytodyn is getting invaluable data on leronlimab from this first trial dedicated to mCRC. Maybe it's the type of cancer, maybe its synergy with Avastin, maybe leronlimab helps the gut microbiome, maybe it is the salutary effect of leronlimab on liver mets--but things are looking better than I would have expected for both cohorts. We wouldn't have known this if it was LL and straight to the ICI (and then Merck would claim most of the glory anyway!). And as the trial progresses we are tracking and measuring everything relevant to leronlimab's MOA, and doing the dose comparisons that the FDA will demand sooner or later. (See Project Optimus). If Cytodyn/Creatv/Natera can come up with a reliable biomarker... well man, game over... On your knees, Big Pharma! I'm expecting some miracles out of the TNBC EAP trial... and we will have clean, exhaustive data in mCRC to back it up and explain it all to a disbelieving public. And cautious medical experts like Dr Rubin... who will apparently need to get slapped around with a briefing book or two before admitting he missed the CCR5 train as it barrels on by...
I was flummoxed by much of what Rubin said in the article ScoreCarder provided. Here's the most egregious quote: "With the proliferation of advanced tools, such as circulating tumor DNA analyses and complex blood or tissue-based arrays, he said it has become easy to ask more questions than the data can reasonably support at that stage. (What the f**k does that mean?). While such approaches can be scientifically attractive, Rubin cautions that their value is limited in the absence of demonstrated efficacy or dose clarity, and may distract from more fundamental development decisions." Advice like that reeks of entitled, we know best, self-serving, know-it-all-ism. We'd be back in 2019 if we thought like that or followed his counsel. I am hopeful he never gets anywhere near Cytodyn in a professional capacity.
Cytodyn is getting invaluable data on leronlimab from this first trial dedicated to mCRC. Maybe it's the type of cancer, maybe its synergy with Avastin, maybe leronlimab helps the gut microbiome, maybe it is the salutary effect of leronlimab on liver mets--but things are looking better than I would have expected for both cohorts. We wouldn't have known this if it was LL and straight to the ICI (and then Merck would claim most of the glory anyway!). And as the trial progresses we are tracking and measuring everything relevant to leronlimab's MOA, and doing the dose comparisons that the FDA will demand sooner or later. (See Project Optimus). If Cytodyn/Creatv/Natera can come up with a reliable biomarker... well man, game over... On your knees, Big Pharma! I'm expecting some miracles out of the TNBC EAP trial... and we will have clean, exhaustive data in mCRC to back it up and explain it all to a disbelieving public. And cautious medical experts like Dr Rubin... who will apparently need to get slapped around with a briefing book or two before admitting he missed the CCR5 train as it barrels on by...
I was flummoxed by much of what Rubin said in the article ScoreCarder provided. Here's the most egregious quote: "With the proliferation of advanced tools, such as circulating tumor DNA analyses and complex blood or tissue-based arrays, he said it has become easy to ask more questions than the data can reasonably support at that stage. (What the f**k does that mean?). While such approaches can be scientifically attractive, Rubin cautions that their value is limited in the absence of demonstrated efficacy or dose clarity, and may distract from more fundamental development decisions." Advice like that reeks of entitled, we know best, self-serving, know-it-all-ism. We'd be back in 2019 if we thought like that or followed his counsel. I am hopeful he never gets anywhere near Cytodyn in a professional capacity.
20
