Roche Reports Results of Gazyva (obinutuzumab) in P-II NOBILITY Study for Lupus Nephritis

Shots:

• The P-II NOBILITY study involves assessing of Gazyva + mycophenolate mofetil/ mycophenolic acid and corticosteroids vs PBO + MMF/MPA and corticosteroids in 125 patients with ISN/RPS 2003 class III or IV proliferative lupus nephritis
• The P-II NOBILITY study results:  met its 1EPs & 2EPs, CRR @52-76 wks. (40% vs 18%); improvement in overall renal response and serologic markers of disease activity; @76wks. SAEs (24% vs 29%); serious infection (6% vs 18%)
• Gazyva is mAb targeting CD20, act by attacking targeted cells both directly and together with the body’s immune system and has received FDA’s BT designation in Sept’19

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