Genmab — November 2015
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Lidt TA-sna
k på Genmab http://play.borsen.dk/social/563f6a79725ed7540a0c6988 -
Jan nævnte bl.a. i Q2 CC, at der ligger interim og futility analyser i begge studier, men ville ikke komme nærmere ind på præcist hvorledes det er skruet sammen udover, at man efter et vist antal patienter skal opnå en vis procentdel forbedring af PFS - et bud kunne være måske når data kendes for 30-40% af patienterne. Hvor meget bedre PFS skal være har jeg ikke lige et bud på, men han sagde man kunne kige på andre fase III studier med interim data og få en ide om niveauet
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Man kan måske få en ide ved at kigge på Kaplan-Meier PFS kurverne for Elotuzumab fra Eloquent-2 studiet, hvis/når disse er tilgængelige, for at få en ide om hvor lang tid det tager at få 30-40% af patienterne at komme i progression - det er nok et meget godt billede af hvornår vi ca. kan håbe på en mulig positiv interimanalyse
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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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