Genmab — Juli 2018
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Min pointe er, at safety baseret på behandling af 25 patienter ikke har meget statistisk basis. Derfor det oprindelige spørgsmål - ved vi om studiet er egnet til registrering?
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Der findes nu vist også allerede noget mere. Se omtale af to fase 2 studier på Ash 2017 her. https://www.mdedge.com/hematologynews/article/155244/multiple-myeloma/daratumumab-looks-good-light-chain-amyloidosis. To studier rekrutterer også i mono på CT.
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Det virker som et spm til noget q&a. Selv med monobehandling, orphan status og sbla ansøgning virker det noget tyndt datamæssigt på mig
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Men når det er sagt, så har de to mono/2nd Line studier primary completion juni/august i år - så der bliver langt om længe noget read out
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Og mens vi venter på maia, vil jeg lige bringe op, at pfs tilsyneladende ikke er nået i Alcyone endnu.
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Same as the F(ab′)2 article yesterday morning, but slightly easier to read / https://www.archyworldys.com/greifswald-scientists-can-restore-transfusion-safety-in-new-drugs/
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Yup. It may have happened and is just not reported.
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Anonymous Broker
Svenska Handelsbanken AB
7 487 1 030 10:09:24 -
But if it has NOT happened Alcyone ought to become the new SOC in the US....
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That is how crazy dara is in MM
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Det er ret svært, da der ikke foreligger fase 2 på previously untreated
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men pfs vil være væsentlig længere end den fra CASTOR
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tag et kig på den seneste præsentation (side 11) - http://ir.genmab.com/static-files/ec8aa24f-90c6-44ea-8788-3f964cf21e73
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