The thing about OS

[biopearl123]

Patients with LR MDS die from a multitude of causes including progression to HR/AML, infection, development of cardiovascular disease and iron overload complications ("One unit of transfused blood contains about 200-250 mg of iron. In general, patients who receive more than 10 to 20 units of blood are at a significant risk of iron overload."). OS is an absolute end point since it is "clean"--you die. In looking at the IMerge study the patients had to have had an absolute number of at least 50 transfusions, probably more, (my guess) before getting into the study in the first place. It would be interesting to see the absolute number of transfusions per patient prior to Imetelstat treatment and then ask the question if OS would be improved if Imetelstat could be started much earlier in the course of the disease. Same question for the progression to HR/AML and the effect of treatment timing on disease progression (the long sought disease modification question). This most recent abstract showed no adverse effect on OS (thankfully) but it may be difficult to prove a positive OS effect without starting treatment much earlier rather than subject patients to therapies that may not work well and still require ongoing transfusions. Also by waiting to start Imetelstat the patients simply get older and get other diseases associated with age particularly cardiovascular diseases, this too will affect OS since OS is a function of all cause mortality. bp

[biopearl123]

https://www.ncbi.nlm.nih.gov/books/NBK562146/

[LWS]

Focusing on Overall Survival (OS) Time

This pending NDA deals with Transfusion Independence (TI), but there were other considerations at ODAC (March 14). OS, of all of the parameters, appears to be the most important. As I remember, OS has been very impressive in several of the ongoing trails. We have only seen the EHA abstract (EHA meeting June 13-16). This paper (with many blood-cancer-expert authors) appears to have several purposes in mind to advance the importance of and need for Imetelstat, with OS being at the forefront of this paper's discussion.

I would like to see a summary of OS data, to date. I believe it is very impressive (living longer with hope for a better, longer life and possible remissions or cures).

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Interesting how the subjects are listed in the title:

1/ OVERALL SURVIVAL
2/ CLINICAL BENEFIT
3/ DURABLE TRANSFUSION INDEPENDENCE

This could be considered a list of important successes, with overall survival time and the quality of life (clinical benefit -- fatigue, feeling good, disease modification, hemoglobin level) being more important than transfusion independence, which is very important. Also, June 16th looks like an important date (EHA, FDA deadline). As John Scarlett said: These are not separate processes, but all part of the blood-cancer transformations (paraphrase) at the molecular level. --from LWS
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OVERALL SURVIVAL, CLINICAL BENEFIT, AND DURABLE TRANSFUSION INDEPENDENCE WITH IMETELSTAT IN THE IMERGE PHASE 3 TRIAL OF RED BLOOD CELL-TRANSFUSION DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES