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Genmab — November 2018

Planlagt Fastgjort Låst Flyttet Genmab
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  • JørgenVarnæsJ Offline
    JørgenVarnæsJ Offline
    JørgenVarnæs
    wrote on sidst redigeret af
    #411

    do we know that SC eliminates the initial administration issues?

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    • JørgenVarnæsJ Offline
      JørgenVarnæsJ Offline
      JørgenVarnæs
      wrote on sidst redigeret af
      #412

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

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      • E Offline
        E Offline
        E_L
        wrote on sidst redigeret af
        #413

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

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        • BulderB Offline
          BulderB Offline
          Bulder
          wrote on sidst redigeret af
          #414

          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.

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          • BulderB Offline
            BulderB Offline
            Bulder
            wrote on sidst redigeret af
            #415

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

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            • E Offline
              E Offline
              E_L
              wrote on sidst redigeret af
              #416

              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

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              • JørgenVarnæsJ Offline
                JørgenVarnæsJ Offline
                JørgenVarnæs
                wrote on sidst redigeret af
                #417

                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

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                • JørgenVarnæsJ Offline
                  JørgenVarnæsJ Offline
                  JørgenVarnæs
                  wrote on sidst redigeret af
                  #418

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

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                  • JørgenVarnæsJ Offline
                    JørgenVarnæsJ Offline
                    JørgenVarnæs
                    wrote on sidst redigeret af
                    #419

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

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                    • BulderB Offline
                      BulderB Offline
                      Bulder
                      wrote on sidst redigeret af
                      #420

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

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                      • JørgenVarnæsJ Offline
                        JørgenVarnæsJ Offline
                        JørgenVarnæs
                        wrote on sidst redigeret af
                        #421

                        also for the subsequent doses?

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                        0
                        • BulderB Offline
                          BulderB Offline
                          Bulder
                          wrote on sidst redigeret af
                          #422

                          Could be a good Q for the Q&A

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                          • E Offline
                            E Offline
                            E_L
                            wrote on sidst redigeret af
                            #423

                            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?

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                            • BulderB Offline
                              BulderB Offline
                              Bulder
                              wrote on sidst redigeret af
                              #424

                              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.

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                              • E Offline
                                E Offline
                                E_L
                                wrote on sidst redigeret af
                                #425

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

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                                • JørgenVarnæsJ Offline
                                  JørgenVarnæsJ Offline
                                  JørgenVarnæs
                                  wrote on sidst redigeret af
                                  #426

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

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                                  • JørgenVarnæsJ Offline
                                    JørgenVarnæsJ Offline
                                    JørgenVarnæs
                                    wrote on sidst redigeret af
                                    #427

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

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                                    • BulderB Offline
                                      BulderB Offline
                                      Bulder
                                      wrote on sidst redigeret af
                                      #428

                                      Who makes a Q to Winkel about this?

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                                      • BulderB Offline
                                        BulderB Offline
                                        Bulder
                                        wrote on sidst redigeret af
                                        #429

                                        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,

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                                        • JørgenVarnæsJ Offline
                                          JørgenVarnæsJ Offline
                                          JørgenVarnæs
                                          wrote on sidst redigeret af
                                          #430

                                          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

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