Why Dr. Scarlett and Co. are smiling
Posted: Sun Nov 13, 2022 9:24 pm
Take a look at the current abstracts submitted to ASH. Specifically look at what we know so far beyond TI, duration of drug effect, depth of response etc. Take a look at over all survival and progression free survival. Here is Geron’s criterion for PFS in IMerge:
“ Progression Free Survival (PFS) [ Time Frame: During study (approximately 2 years) ]
Progression free survival will be assessed as the time interval from study Day 1 to the first date of disease progression or death from any cause, whichever occurs first. As per IWG criteria disease progression is defined as: at least one of the following: at least 50 percent (%) decrement from maximum response levels in granulocytes or platelets; reduction in hemoglobin by greater than or equal to (>=) 1.5 gram per deciliter (g/dL); transfusion dependence.”
Here is the definition for PFS presented in Dr. Santini’s abstract on Luspatercept:
“PFS was defined as the time from MDS diagnosis to acute myeloid leukemia progression.”
Pretty different to my eye. Now go read the abstracts for both the Medalist and the IMerge studies that are being presented. Again, while we don’t have the COMMANDS data yet, the PFS and OS Luspatercept data to date does not look overwhelming. (Progressive disease seems to be driving by genetic signature and very low risk disease rarely transforms to AML). Considering the known MOA of Luspatercept (works by enhancing late stage erythrocyte maturation) and Imetelstat (kills the malignant clone and abnormal progenitor cells), the former would be expected to improve the need for blood transfusions, hospitalizations, iron overload etc. (a good thing), the latter would be expected to change the course of the entire disease (need for blood transfusions, hospitalizations, iron overload, PFS, overall survival, bone marrow picture, transformation to AML.) And this is why Geron has a booth this year. And after conference presentations. And this is why Dr. Scarlett and Co are smiling. I think Dr. Scarlett suggested we stay tuned, probably not a bad idea. bp
“ Progression Free Survival (PFS) [ Time Frame: During study (approximately 2 years) ]
Progression free survival will be assessed as the time interval from study Day 1 to the first date of disease progression or death from any cause, whichever occurs first. As per IWG criteria disease progression is defined as: at least one of the following: at least 50 percent (%) decrement from maximum response levels in granulocytes or platelets; reduction in hemoglobin by greater than or equal to (>=) 1.5 gram per deciliter (g/dL); transfusion dependence.”
Here is the definition for PFS presented in Dr. Santini’s abstract on Luspatercept:
“PFS was defined as the time from MDS diagnosis to acute myeloid leukemia progression.”
Pretty different to my eye. Now go read the abstracts for both the Medalist and the IMerge studies that are being presented. Again, while we don’t have the COMMANDS data yet, the PFS and OS Luspatercept data to date does not look overwhelming. (Progressive disease seems to be driving by genetic signature and very low risk disease rarely transforms to AML). Considering the known MOA of Luspatercept (works by enhancing late stage erythrocyte maturation) and Imetelstat (kills the malignant clone and abnormal progenitor cells), the former would be expected to improve the need for blood transfusions, hospitalizations, iron overload etc. (a good thing), the latter would be expected to change the course of the entire disease (need for blood transfusions, hospitalizations, iron overload, PFS, overall survival, bone marrow picture, transformation to AML.) And this is why Geron has a booth this year. And after conference presentations. And this is why Dr. Scarlett and Co are smiling. I think Dr. Scarlett suggested we stay tuned, probably not a bad idea. bp