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Posted: Thu May 14, 2020 4:29 pm
Smart people: What say you?
Re: EHA Abstracts
Posted: Fri May 15, 2020 12:39 am
Muskateer, Unfortunately I am not the person you are looking for but I do have a few observations to share. In MDS first off, a prestigious oral presentation confirming the durability of TI. Its major, looks to me like there is nothing close. Since we only see the abstract, I suspect we will be treated to more detailed data to confirm effect on the malignant clone and I hope some detailed bone marrow data. Its just getting better. I don't see other presentations that specifically approach lower risk transfusion dependent patients but there is a poster relating to Rux that continues to show good effect in less sick patients. I will spend some time with this since I want to sort out whether this data again involves ringed sideroblast patients (15 %) or all comers. This will be important going forward re size of marker. For MF several posters, all important. We are now seeing that if there is a direct effect on the telomere or h-TERT, there is a much higher effect re symptoms and spleen. FDA got to love that. What I don't see is the additional RWD I expected from the late addition from Italy and Lake Success. That is is big question mark and I bet we can't get Scarlett to clarify either (unless we see this presented as a late breaker!!--to much to hope for.) We also don't know about the two recent additional to Geron's staff and Scarlett is keeping that under his hat. I have not read all the abstracts by a long shot so there may be a lot I have missed to date. If you want to contribute, look for studies that show "disease modification", "transfusion independence", improvement in bone marrow picture and longevity. Also remember that the domaine for MDS is lower risk when trying to compare studies. The data for triple negative MF stands alone and there is nothing close. Even if one splits this good data out, the MOS for the rest has still doubled(!). So far I don't see anything that comes close to the MDS TI data either--this from the MDS study: "Imetelstat achieved an 8-w TI rate of 42% for a median duration of 20 mo, the longest so far reported with any agent in non-del 5q LR-MDS, and 29% of pts achieved TI ≥ 1 y. Furthermore, a high and durable HI-E rate (68% for median of 21 mo) was also achieved in this population of heavily RBC TD, ESA-R/R LR-MDS. Enrollment is ongoing in the Phase 3 portion of IMerge, a placebo-controlled trial of the efficacy and safety of imetelstat, including potential predictive biomarkers of response." Note the comment, "the longest reported with ANY AGENT in not-del 5q LR-MDS" (emphasis mine). This subgroup of non del q patients still represents that majority of all patients int the LR MDS group. Hope this helps, stay healthy everyone. Please contribute thoughts as you read through the abstracts. It is very likely I missed something.
Good luck and best wishes. bp
Re: EHA Abstracts
Posted: Fri May 15, 2020 9:09 pm
I think this copy/paste of what I wrote on Yahoo! pretty much sums it up:
Piles and piles and piles of flimsy data...
All that flimsy data stacked on itself over the course of over a decade, adds up to -
A drug therapy (in mono) that has proven* to have a strong safety profile and oh by the way delivers clear* efficacy to patients in an unmet need... particularly in specific patient cohorts, a patient set that happens to have a horrible expected outcome.
*Proven means it’s been shown, via lots and lots and lots flimsy data, that the hypothesis has been validated.
Hypothesis - “Tantamount to a cure in some patients”