Genmab — September 2019

[E_L]

Daratumumab for Relapsed or Refractory AL Amyloidosis with high Plasma Cell Burden. https://onlinelibrary.wiley.com/doi/abs/10.1002/hon.2677#.XXEfIDXbqeM.twitter

[E_L]

"
We conclude that daratumumab is a very effective and safe treatment option in AL patients with relapsed/refractory disease, and high disease burden at diagnosis. Daratumumab leads to rapid disease control, and improvement of organ function."

[Helge_LarsenPI-redaktør]

Det må siges at være en overbevisende konklusion.

[Helge_LarsenPI-redaktør]

1.430. 52.000 stk i auktionen.

[gentogen]

Et lille studie, men Complete remission (CR) was observed in 40% (n=4) of patients

[gentogen]

Selv om det var high tumor burden AL amyloidosis patients, der angiveligt var meget mere syge end i tidligere studier

[AaBforever]

Spændende hvad retningen bliver i morgen.

[Bulder]

Det har været nævnt før, at dara var mere effektiv i amy end i MM. Lover godt for Andromeda.

[Sukkeralf]

Ja og Jan sagde på seneste CC at der var mulighed for interim data i nærmeste fremtid

[E_L]

submission will still take some time won't it? what is our best guess?

[Bulder]

Submission q2 2020. Approval late 2020 would be my guess.

[Bulder]

Study has primary completion feb 2020.

[E_L]

i guess it will be a good candidate for RTOR

[Bulder]

Winkel: And what would we expect? I mean, the data up to now from the (inaudible) patients is incredibly good. Very, very high levels of a percentage of patients getting into very dramatic hematological responses.

[Bulder]

The amy market isn't as big as MM, but dara could get a bigger market share.

[Bulder]

Interim read out could be expected in the coming months, but i guess they'll wait for the full data before they submit anything.

[bibob]

Dara is the superdrug which can be used in a lot of indications, and i think a lot more than we know at the time.

[E_L]

i think so too & that is why i am keen to get at least a second indication approved already

[E_L]

and i am super curious what will happen when we get the SC approval... i think new studies will follow shortly thereafter....

[Sukkeralf]

Bulder I guess they will file on interim if they are good enough - like they did with most of the phase III studies in MM