Genmab — November 2018

[Parasitism]

God morgen

[peter12]

Der er også nogen der bliver tørret i dag

[Helge_LarsenPI-redaktør]

Just a moment...

(www.proinvestor.com)

[E_L]

New trial: Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax https://clinicaltrials.gov/ct2/show/NCT03701321?term=NCT03701321&rank=1

[E_L]

it's a shame they don't yet start using SC in these new trials. Note though MRD as primary outcome.

[Sukkeralf]

they probably need sc dosing approved first

[bibob]

I think you are right Sukkeralf,!! - but when approved do you then think that they can change the study to use sc instead of iv. It looks like that sc has a better safety profile than iv !! - or am I wrong ??

[gentogen]

Tror ikke dette studie med Dara har været omtalt her (?): Myeloma-Developing Regimens Using Genomics (MyDRUG) (MyDRUG). The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled

[gentogen]

ClinicalTrials.gov

(clinicaltrials.gov)

[Helge_LarsenPI-redaktør]

God morgen.

[bibob]

God morgen.

[E_L]

God morgen. this Dara/Atezo NSCLC trial keeps intruiging me (probably in vain lol ), but why do you recruit 100 patients in a trial that does not work… https://clinicaltrials.gov/ct2/history/NCT03023423?A=22&B=23&C=merged

[E_L]

@bibob ; changing from IV to SC in the middle of a trial would mess up the (safety)data, no?

[laerlingen]

Hvis studiet er startet får man ikke lov til at ændre i protokollen

[Bulder]

I suppose the study goes on to find out what went wrong.

[bibob]

@E L. and laerlingen. Ok, then they have to start a new trial, but they know the safety. ? could the new trial then be approved faster maybee.??

[Bulder]

Det er set før, at man har ændret i protokollen efter start. Men en så gennemgribende som administrationsmåden gør man næppe. I øvrigt er det jo et ISS-studie - og ikke Janssen - som går ud på at finde ud af hvordan dara og Venetoclax spiller sammen og ikke om sc er bedre end iv. Førtst i det øjeblik at sc er blevet standard vil man bruge det - vil jeg tro.

[Bulder]

Det er kun et fase 1-2 og et evt. senere fase 3 godkendelsesstudie vil sagtens kunne gå over til sc.

[nohope]

Hvis man skal være bagklog, hvilket er en af mine spidskompetencer, så kunne man have lavet en 3. arm der var sc. Men det forsøg er måske planlagt længe inden sc var alvor.

[Bulder]

Det kunne man. Og det er også set at man senere har tilføjet en ny arm med sc-dosering. Men spørgsmålet er om NCI overhovedet har interesse idet. Det koster jo.