Genmab — Juli 2014
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The delay reflects a decision to initiate additional arms to the ongoing Phase I/II trial to explore more frequent dosing i.e. once-weekly vs once-fortnightly, both with and without concomitant dexamethasone. As a reminder, no clinical data for MOR202 has yet been presented. MOR202 combination Phase I/II trials to start “around the end of the year”
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addition, to announcing an extension to its Phase I/II trial, MorphoSys announced that a first combination trial of MOR202, with Celgene’s Revlimid and Pomalyst, will be initiated “around the end of 2014”. As a reminder, Janssen first initiated a Phase I combination trial of daratumumab in June 2012 (implying a 2.5 year lead over Celgene/MorphoSys).
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MorphoSys continue to believe there are opportunities to narrow this gap between it and competitors by targeted development in “specific patient populations”. We believe one option could be a randomised Phase II/III trial with and without Pomalyst in patients refractory to Velcade/Revlimid (third-line).
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We estimate such a trial could be completed in 24-30 months. However, Celgene/MorphoSys are unlikely to be in a position to initiate pivotal combination trials until late 2015 at the earliest and more likely mid 2016, suggesting data is unlikely before late 2018 or 2019. By this time Janssen and Genmab will have published data for daratumumab combinations in the second-line and potentially first-line settings
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We remain confident Genmab/Janssen has a significant lead on its competitors The delay to publication of data on MOR202 and the decision to explore more frequent dosing underlines the advantage Genmab and partner Janssen has in terms of lead-to-market. We also note that Sanofi recently expanded a Phase I dose escalation trial of its CD38 antibody, SAR650984.
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Our discussions with the lead investigators of this trial at ASCO suggested a need/desire to explore higher doses before progressing to further trials. As a reminder, Janssen has already initiated three randomised Phase III trials with daratumumab, with data due from mid 2017.
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In addition, we expect data from a potential pivotal single arm trial in refractory patients at the ASH meeting this year, with filing in 2015. We continue to be positive on Genmab’s shares based on our view on the potential of daratumumab for multiple myeloma (MM; DBe peak sales $2.4bn).
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Hvem er det der anbefaler?
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Takker.
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Genmab stiger på efterbevilling
10:42
Købsordrerne går atter Genmabs vej onsdag, og noget tyder på, at interessen skyldes meldinger fra en konkurrent i mandags. Det vurderer chefaktierådgiver i Nordea Torben Høyer over for Ritzau Finans. http://www.proinvestor.com/chathistory/-25/genmab
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