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Genmab and Janssen Biotech Report Initiation of P-III MMY3021 Study for Darzalex (daratumumab) in Multiple Myeloma

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Genmab and Janssen Biotech Report Initiation of P-III MMY3021 Study for Darzalex (daratumumab) in Multiple Myeloma

Shots:

  • The P-III MMY3021 study involves assessing of daratumumab (1800mg- SC) + lenalidomide vs lenalidomide as monothx. in 214 newly diagnosed multiple myeloma patients who are MRD + after autologous stem cell transplant (ASCT) with no prior anti-CD38 exposure
  • In H1’19 the companies plan to initiate the P-III MMY3021 study for daratumumab with 1EPs as MRD conversion rate- from MRD positive to MRD negative in 12mos. for 36 cycles
  • Darzalex (daratumumab-1800 mg- SC) is an IgG1k mAb binds with CD38 molecule targeting the tumor cells death via immunomodulatory action and has received FDA’s BT designation for multiple myeloma. In Aug-2012 Janssen acquired exclusive WW rights to develop- manufacture and commercialize daratumumab

Ref: Genmab | Image: Janssen

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