Hope Rugo, MD
Updated findings of the phase III SOPHIA trial showed that margetuximab plus chemotherapy led to an increase in progression-free survival (PFS) and an overall survival (OS) compared with trastuzumab (Herceptin) plus chemotherapy in patients with HER2-positive metastatic breast cancer who had previously received HER2-targeted therapies, explained Hope S. Rugo, MD, FASCO.
The second interim OS analysis was based off of 270 OS events and showed that, at a median follow-up of 15.6 months, the median OS in the intent-to-treat population was 21.6 months (95% CI, 18.86-24.05) with margetuximab plus chemotherapy versus 19.8 months (95% CI, 17.54-22.28) with trastuzumab plus chemotherapy (HR, 0.89; 95% CI, 0.69-1.13; P
= .326). The final prespecified OS analysis is planned after 385 events have occurred, which will likely occur in late 2020.
The investigator-assessed PFS showed a 29% reduction in the risk of disease progression or death with margetuximab compared with the trastuzumab arm. The median PFS for margetuximab/chemotherapy was 5.7 months (95% CI, 5.22-6.97) versus 4.4 months (95% CI, 4.14-5.45) for trastuzumab/chemotherapy (HR, 0.71; 95% CI, 0.58-0.86; P
“Overall, the SOPHIA trial showed that margetuximab is safe and similar to trastuzumab and can be given [to patients with HER2-positive breast cancer],” said Rugo, a professor in the Department of Medicine and director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center.
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