Genmab — November 2018

[Bulder]

I don't rember Winkel having said January. But Novod have spoken about Q1.

[Solsen]

When dosing in iv was fixed it was on a very few pts I recall. So the higher conc. in blood could very well be a gamechanger.
We know SAE is much better in sc and the bottleneck related to infusion time are gone with the 3-5 min sc

[Solsen]

Thanks bulder !

[JørgenVarnæs]

do we know that SC eliminates the initial administration issues?

[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