Genmab — Januar 2019

Plimsoller

Ok.

Plimsoller

Er der ikke planer om at vi hører noget fra SC allerede i H2 2019?

Solsen

H119

E_L

@nope ; you can’t expect elderly, frail patients to stay up overnight for an infusion…

E_L

many patients choose their treatment based on practical considerations; if you have a full time job and bad insurance you just can’t stay away from work for too many days to get treatment. Sad but true

E_L

so not necessarily the best treatment

E_L

But before we get SC, dont forget the 90 minute infusion schedule, which is already being used in some large US hospitals; it will already make a HUGE difference

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.