4 ms·

There are a LOT of papers out there about CARs [1], how they work, and what their effects are. The DNA sequence used here has been effectively frozen for quite

There are a LOT of papers out there about CARs [1], how they work, and what their effects are. The DNA sequence used here has been effectively frozen for quite some time as it runs through all sorts of examinations. Further, your link is to the description of an Oral Presentation, not even a paper. It's not supposed to have data associated with it. This is the paper from the Phase I results of the same therapy (I very much appreciate that the paper is open-access): http://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016%2816%2945375-X http://www.cell.com/molecular-therapy-family/molecular-thera... [1] https://www.ncbi.nlm.nih.gov/pubmed/?term=chimeric+antigen+receptor https://www.ncbi.nlm.nih.gov/pubmed/?term=chimeric+antigen+r...

nonbel 9y ago
I followed the link from TFA: "The study that led to approval enrolled 111 patients at 22 hospitals; 101 of them received Yescarta. They had one of three diseases: diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or transformed follicular lymphoma." The study that led to approval is unpublished.
nonbel 9y ago
Thanks, here is an example of the type of questions I would expect a doctor to ask (which is impossible if no study is published). Looking at your paper I can't really tell what they did to determine CR. Did they only do PET-CT? The paper they cite[1] mentions some biopsies (for some cases), etc but they only show any results for that assay. Assuming it was only PET-CT for now, they say[1]: "Typically FDG-avid lymphoma: in patients with no pretreatment PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative." So positive/negative is apparently based completely on relative metabolic activity. Just looking at figure 1B in your paper, it appears that baseline vs 30 days is done perhaps using different exposures. Or for some reason the intestines were much more active at 30 days (patients ate more recently?). 1) How do they ensure there isn't some response to the drug/environment that has increased general metabolic activity, thus decreasing the relative signal from the tumor? 2) Were the people processing and examining these scans blinded to the fact they were part of a drug trial? There seems to be ample room to play with exposures, etc here. [1] http://ascopubs.org/doi/10.1200/JCO.2006.09.2403 http://ascopubs.org/doi/10.1200/JCO.2006.09.2403

nonbel 9y ago

I followed the link from TFA: "The study that led to approval enrolled 111 patients at 22 hospitals; 101 of them received Yescarta. They had one of three diseases: diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or transformed follicular lymphoma." The study that led to approval is unpublished.

nonbel 9y ago

Thanks, here is an example of the type of questions I would expect a doctor to ask (which is impossible if no study is published). Looking at your paper I can't really tell what they did to determine CR. Did they only do PET-CT? The paper they cite[1] mentions some biopsies (for some cases), etc but they only show any results for that assay. Assuming it was only PET-CT for now, they say[1]: "Typically FDG-avid lymphoma: in patients with no pretreatment PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative." So positive/negative is apparently based completely on relative metabolic activity. Just looking at figure 1B in your paper, it appears that baseline vs 30 days is done perhaps using different exposures. Or for some reason the intestines were much more active at 30 days (patients ate more recently?). 1) How do they ensure there isn't some response to the drug/environment that has increased general metabolic activity, thus decreasing the relative signal from the tumor? 2) Were the people processing and examining these scans blinded to the fact they were part of a drug trial? There seems to be ample room to play with exposures, etc here. [1] http://ascopubs.org/doi/10.1200/JCO.2006.09.2403 http://ascopubs.org/doi/10.1200/JCO.2006.09.2403