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Novods kommentarer til Genmabs præsentation på ASCO.

72555 Helge Larsen/PI-redaktør 31/5 2015 14:03

Michael Novod fra Nordea vurderer Genmabs præsentation... "The late breaking abstract on Daratumumab from the pivotal ph II trial was released this morning at ASCO and in our view, it shows very solid data in the MM breakthrough designation population. In these very heavily pre-treated patients (median 5 prior lines of treatment) where 96% of patients were refractory to last PI or IMiD therapy, Daratumumab monotherapy gave an ORR (overall response rate) of 29.2%. Of the 106 patients in the trial 63% were refractory to Pomalyst (pomalidomide) and 48% were refractory to Kyprolis (carfilzomib). Yet the Dara data is stronger than what these two agents were recently approved on in less sick patients (see table below). Particularly interesting is the 3 stringent CRs and the 10 VGPRs in the Dara trial which is much better than what have been seen for eg. Kyprolis. Median overall survival (OS) was not reached at the time of abstract submission and 1-year overall survival rate was estimated to be 65%. The Dara data is unprecedented as no antibody has ever shown a ~30% ORR as monotherapy in such heavily pre-treated patients (also see press briefing below), and it of course supports likely approval on back of these data. The reported side effect profile for Dara seem benign relative to other MM therapies with only 4.7% discontinuation due to adverse events (none assessed to be drug related) and only 30% of patients experiencing SAEs - thus confirming the picture seen in previous Dara trials. Infusion site reactions remain prevalent, however mainly at the first infusion. We view these data as very solid and expect J&J filing soon. We are present at ASCO where we are meeting a range of MM KOLs and the Dara data will also be presented by on June2 in oral session. We remain buyers of Genmab and believe the stock should see support from the ASCO data."