Genmab — November 2015
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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
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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
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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.
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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.
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Lidt causeri om Genmab http://medwatch.dk/Medicinal___Biotek/article8197259.ece?utm_source=Feed&utm_medium=latest
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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. -
Det er jo ikke et helt nemt regnestykke uanset hvad, da patienterne også indrulles løbende og vel færdigindrullet i Pollux midt på året. 40% af patienterne er gået i progression efter 16 måneder for Elo/Len/Dex armen. Så i dette tilfælde ville vi måske få interimdata sent i 2016. Mit eget løse bud vil måske være sommeren 2016, men det er jo lidt svært at komme helt nær
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