EHA

[biopearl]

An abstract has been accepted for oral presentation at the EHA meetings. Not a poster. Abstract is embargoed until then (mid June). Suspect this will help confirm durability of MDS TI. bp

[biopearl]

Here's the link, note Dr. Raza as second author and plenty of representation from Janssen:

https://learningcenter.ehaweb.org/eha/2 ... 74*media=3

[jpheis]

BP- many thanks for the link. If you have the time I would sincerely appreciate your take on the abstract. I am impressed this is oral, as that criteria is far more stringent than a poster. And I am quite aware an abstract and actual presentation likely and most often vary dramatically. I’m tempted to comment on the TI landmarks. However my CV doesn’t cover anything close yours.

[biopearl]

jpheis, I agree, an oral presentation clearly carries more weight than a poster, so that is good. The presentation is listed to occur in a room rather than an auditorium but as I am not familiar with the conference venue I can't put too much weight on just how big an audience is expected to attend. I, like yourself am struck by the ongoing durability that appears to be emerging (a small joke there). 70 plus weeks of MEDIAN follow up is getting up there and a continued very high percentage of patients with hematologic improvement across the board appears to continue. The naive subgroup continues to show very substantial TI. This study looks to be an extension of the data we are already familiar with, just for a longer period of time. It is possible that further and more up to the minute data may be presented during the actual talk. This will probably lend further weight to what we know is very very good data. Janssen is well represented on this paper as are multiple European authors as well as a Russian. Worldwide is a word often used by Dr. Scarlett and with Janssen's European history and connections I would not be surprised to see very strong EMEA interest. I believe with the current phase III design, early statistical clarity will be achieved and the study will fulfill the requirement of a placebo arm. My opinion is that this study will stop early for statistical significance (once they get going in the first place) if the data mirrors what we are seeing now, and we will not have to wait for the current projected time table. The current abstract again mentions that median time to onset of drug effect is only 8 weeks, and the primary end point for phase III again is 8 weeks of TI. It just won't take that long to do this study, especially if enrollment is fast as it is likely to be based on the phase II data. bp