Genmab — November 2018

[JørgenVarnæs]

or is that something we still need to see from the studies?

[E_L]

not a complete answer JV, but close, maybe we hear more in the actual presentation https://ash.confex.com/ash/2018/webprogram/Paper113590.html

[Bulder]

It looks like there still is a bit of IRRs in the first dose, but much les than IV: The incidence (16%) and severity of IRRs (mostly grade 1-2) with DARA SC was low, the majority of which occurred on Cycle 1 Day 1, and no discontinuations due to IRRs were observed.

[Bulder]

They still talk only about 3-5 minutes. Could be 5 minutes first time, then 3 min thereafter.

[E_L]

It would be hard anyhow, right? with IV they often stop for a while/pauze on the first day in case of problems, but if you get a 5 minute shot, there is little time to stop lol

[JørgenVarnæs]

from what i recall - SC is being tested "stand-alone". The first dose is also SC. But I'm guessing an SC dose as an out patient is much easier/faster than the two-day IV first dose

[JørgenVarnæs]

Bulder - do you know if SC first dose is administered at home or under supervision?

[JørgenVarnæs]

But SC administration will eliminate the bottleneck issues no matter where it is administered

[Bulder]

In a clinic. According to Winkel home-administration is not possible at all.

[JørgenVarnæs]

also for the subsequent doses?

[Bulder]

Could be a good Q for the Q&A

[E_L]

Do I have this right on AMG420; they started this study in 2015, recruited only 35 patients of which 21 had disease progression , but they are talking positive about the 5(!!) that are still remaining?

[Bulder]

I don't know if they have a hjemmesygeplejerske system in US. If they have home administration should be possible. If we talk about self-administration a syringe pump is nescessary. Then it takes 20 min as I remember it.

[E_L]

The Legend study to be honest i dont know. I also don't trust these guys…

[JørgenVarnæs]

I had a gander at the durability of the drug - seems if it is refrigerated dara has a shelf life of 24 months

[JørgenVarnæs]

you can keep dara in your fridge at home and shoot it just like insulin

[Bulder]

Who makes a Q to Winkel about this?

[Bulder]

I asked him long ago, and he said home adm is not possible. But I've seen Plesner in the Myelomatosebladet say that it will be possible,

[JørgenVarnæs]

maybe its just a question of the trial results coming in? there could be a difference between relatively healthy first line / maintenance patients and subsequent lines

[Bulder]

Men eet er den kæmpe fordel der ligger i tidsbesparelsen og de færre bivirkninger. Noget andet er hvis sc også er mere effektiv. Hvis de 52% ORR i Pavo holder vand - og hvis pts kan sammenlignes med Sirius - Så er det næsten en fordobling af egeneffektiviteten, og historiebøgerne vil skulle skrives om. Alle hidtil kendte data fra Castor, Pollux, Maia mv vil være forældede. Og vi vil formentlig se helt andre effektdata i kombinationerne.