DSMC recommends continuation of MacroGenics' Phase III of margetuximab to treat breast cancer

MacroGenics Inc. (NASDAQ:MGNX) said an independent DSMC recommended continuation of the Phase III SOPHIA trial of margetuximab (MGAH22) to treat relapsed or refractory HER2-positive metastatic breast cancer based on preplanned interim futility analysis of progression-free survival (PFS) data.

The open-label, international trial is evaluating 15 mg/kg IV margetuximab given on day 1 of each 21-day cycle plus chemotherapy vs. Herceptin trastuzumab plus chemotherapy in about 530 patients. The primary endpoints are PFS as measured by an independent radiological review and overall survival (OS). Secondary endpoints include PFS as measured by study investigators and objective response rate (ORR). The company plans to complete enrollment by year end, with top-line data expected in 2019...