RE: Call on Monday31 May 2020 15:20
Thx.
The paper summaries are now available on the asco site by clicking on the submission number in the mid MAY HCM announcement.
Savo in MET14 skipping pts, they have 61 evaluated pts with promising response rates and disease control.....study dat still maturing. The NDA announcement means they are reasonably confident this data set is sufficient for registration.
Savoir - it seems they were too hasty to close the study based on external review of the sutinib comparator, it did not perform as well as expected in the study.....hence it looks like Savoir or some other prcc trial is worthwhile as Savo performed well against sutinib.
Suru, there is a quality of life paper from the China EpNET cohort which supports tolerability for pts. There is a second paper about tolerability in US pts, this suggests no difference from China results. This should help determine the approval pathway exChina.
There are two fruqinitib assessments. The first identifies a group of pts that may benefit more from Elunate. The second is an interim update on v sick gastrointestinal cancer pts showing positive tolerability and efficacy.
These are all positive for HCM. Pointers for Monday,
how do these papers support route to approval
How much extra spend being committed in 20-22 for these products