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Rugo Shares Insight on Intriguing SOPHIA Data in HER2+ Breast Cancer

Ellie Leick
Published: Wednesday, Aug 14, 2019

Hope Rugo, MD

Hope Rugo, MD

Margetuximab, a novel Fc-engineered HER2-targeted antibody, showed improved progression-free survival (PFS) compared with trastuzumab (Herceptin) in patients with pretreated HER2-positive metastatic breast cancer in the open-label phase III SOPHIA trial, explained Hope S. Rugo, MD, adding that the agent is said to have significant immune activity.

Results showed that the median PFS for patients who received margetuximab was 5.8 months versus 4.9 months for those who received trastuzumab (HR, 0.76; P = .033). Additionally, overall survival (OS) in the intent-to-treat population was 18.9 months in the margetuximab arm versus 17.2 months in the trastuzumab arm (HR, 0.95; 95% CI, 0.69-1.31).

The PFS was even greater in patients were carriers of the CD16A-F allele. In this subgroup, data from a planned exploratory PFS analysis showed that the median PFS was 6.9 months in patients randomized to margetuximab versus 5.1 months in those who received trastuzumab (HR, 0.68; P = .005).

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