Shots:

• The approval is based on P-III SOPHIA trial involves assessing of Margenza (IV- 15 mg/kg- q3w) vs Herceptin (trastuzumab- IV- 6mg/kg or 8mg/kg for loading dose) both combined with CT in 536 patients in a ratio (1:1) with HER2-positive m-BC who have received two or more prior anti-HER2 regimens- at least one of which was for metastatic disease.
• The study showed 24% reduction in the risk of disease progression or death- ORR (22% vs 16%)- The final OS analysis is expected in the H2’21
• Margenza is an Fc-engineered- mAb that targets the HER2 oncoprotein- also being evaluated in multiple trials for HER2+ gastroesophageal cancer & various HER2+ tumors

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