Genmab — Januar 2019

[JørgenVarnæs]

...hvordan er det med sc H1 19 - det er RRMM setting. Vil studiet kunne bruges pivotalt i første linie også?

[E_L]

Also the first dose split in 2 will make a difference; currently some hospitals ask patients to come in the night before and thus spend overnight before the first infusion, very costly and time consuming.

[Solsen]

Man mener, at sc-dara vil kunne konverteres til alle godkendte linier - hvis forsøget falder godt ud. Jeg er ikke så meget i tvivl om effekt og sideeffekt. Kun at dara konc i blod ser ud til at være en streg højere end i 16 mg settings kan give problemer - men næppe relevant hvis sideeffects og effekt begge går i rigtig retning.

[JørgenVarnæs]

...er det NCT03412565 (fase2), der er det pivotale i 1st line SC? Den har primary completion I Q3 19

[JørgenVarnæs]

indeholder 199 patienter

[Bulder]

Ja, det er det som sammen med Columba skal danne basis for generel anvendelse af sc

[JørgenVarnæs]

ok - så vi har en horisont på lige nord for 12 måneder for SC I alle linier

[Bulder]

Ja, vi får nok ikke sc med under RTOR, da der er tale om en ny formulering

[nohope]

EL. The solution is easy, let the old fragile patients have daytime, since they are not working and let the strong younger patients in work have the evening/night shift.

[Bulder]

nohope, all patients are old and frail in Maia

[E_L]

Q&A Feb18 - Q: In january you started a “Study to evaluate Subcutaneous Daratumumab in
combination with Standard Multiple Myeloma Treatment Regimens”, which is a Phase
2. You already have the Phase 3 SC vs IV study; could these 2 clinical trials be the
basis for an overall approval of SC in all lines and settings?
Jan : This is a good thought.

[nohope]

I´ve never understood why split dosing is such a great improvement. You have to take same dosis over 2 days. Same patient must be at the hospital twice as many times and be cleared for treatment. You have to do all the manuel procedures twice against a small time gain ?

[Bulder]

You'll have to wait for the asct setting to meet the young ones.

[E_L]

@nohope ; i would take that night chair. unfortunately i think most would not

[nohope]

#Bulder. Maybe Bulder, but EL wrote as if as there were 2 different groups of patients. One fragile and one in work.

[E_L]

most are fragile AND in work lol

[E_L]

well, not lol really

[Bulder]

Det har vi diskuteret før, hohope og linket til ameriknske hospitaler og deres begrundelse for at foretrække split-dosing. Det er simpelt hen nemmere at administrere rent praktisk.

[nohope]

Det skal ikke være nemt, det skal være effektivt- størst mulige gode for flest mulige.

[AaBforever]

Mon der er warrants ude? Danske største nettosælger.