MacroGenics, Inc. announced completion of a pre-planned interim futility analysis of the Phase 3 SOPHIA trial. This randomized, multi-center clinical study compares margetuximab plus chemotherapy to trastuzumab plus chemotherapy in subjects with metastatic breast cancer. Based on results from the futility analysis, an independent data safety monitoring committee (DSMC) has recommended that the SOPHIA study continue as planned without modification. This analysis was based on a pre-specified assessment of progression-free survival (PFS) as determined by independent central review. The futility analysis did not allow for early stopping due to efficacy. MacroGenics also announced that the U.S.FDA has granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy. Fast Track designation is designed to facilitate the development and expedite the review of new therapies for serious conditions and unmet medical needs. With Fast Track designation, early and frequent communications between the FDA and the sponsor are encouraged to help enable rapid development of the candidate molecule.