Genmab — November 2015

[Bulder]

ok, tak

[Sukkeralf]

Fra Q2:

[Sukkeralf]

Hello, Sachin and good to have you on the line. I cannot give you too much details because our partner Janssen doesn’t want me to give the exact definition. But I can tell you – I can guide you in the direction, there is also a certain number of reasons

[Sukkeralf]

When we see a significant percentage increase or larger percent of increase in PFS in the dara containing arm versus the control arm, which will be for example Rev/Dex in the Rev/Dex dara study, once that increase is seen, which is significant then we will approach [indiscernible] both in the US and the Europe and actually discuss the potential for a filing based on that data, and for your reference what we can do is make available studies to control arm

[Sukkeralf]

so that you know roughly the type of PFS we are aiming for in the control arm, and then you can look at other drugs, Sachin , to see what they roughly have used an interim analysis of large Phase III trials, a full percentage increase and this will be very much along the same lines.

[Sukkeralf]

And as I said in my introduction this has been agreed. The exact percentage increase has been agreed already by the authorities both in the US and in Europe, and I cannot give you any further color on that, I’m sorry.

[Sukkeralf]

Jan har også sagt, at hvis de kan søge om godkendelse på baggrund af interimanalyse, så kommer de på markedet 1-2 år før de fleste analytikere venter det - så det er en pæn stor trigger, hvis det skulle ske

[Bulder]

Eloquent 2 er jo med her på ASH, hvor der bl.a. fremlægges 3-års PFS data.

[Sukkeralf]

Ja der bør være kurser på ASH - og måske allerede nu et sted.

[Sukkeralf]

kurser = kurver

[Sukkeralf]

Hvis man kigger på median PFS for Eloquint-2 så hedder den: Patients in the trial who received elotuzumab in combination with Revlimid and dex­a­meth­a­sone had a medi­an progression-free survival of 19.4 months, compared to 14.5 months for patients who received treat­ment with just Revlimid and dex­a­meth­a­sone alone.

[Sukkeralf]

Her er der en fin kurve:

[Sukkeralf]

(www.scoopnest.com)

[Bulder]

Så efter 2 år er 41% stadig i live uden at sygdommen er blevet værre. Men hvordan kommer man derfra og til at slutte noget om hvornår der kan forventes interim-data fra Castor og Pollux?

[Bulder]

Jeg forstår iøvrigt ikke helt: Det Dara kombi-studie, der er med på ASH er med Len+Dex fase 1/2. Pollux er også Dara + Len/Dex men i fase 3. Hvad er forskellen?

[JKY_VH]

Lidt causeri om Genmab http://medwatch.dk/Medicinal___Biotek/article8197259.ece?utm_source=Feed&utm_medium=latest

[Sukkeralf]

Min computer gik lige i koma

[Sukkeralf]

Her lidt mere fra Q&A

[Sukkeralf]

No, that’s fair. Percentage increase I’m comfortable. My question was regarding the number of events. So it's like less studies is for 550 patient, so the number of events you’re looking for is, is it like almost half of the patients would have been that or 300 patients.

Jan van de Winkel - President & Chief Executive Officer
It’s likely a smaller set seven of patients, but I cannot give you the exact number.

[Sukkeralf]

Så der skal altså være en vis forøgning af PFS efter en mindre del af patienterne - det var derfor jeg gættede på 30-40% af patienterne.