MacroGenics (MGNX) announced positive results from SOPHIA

MacroGenics announced positive results from SOPHIA, a Phase 3 clinical study of margetuximab in HER2-positive metastatic breast cancer patients

• The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. Patients in the margetuximab arm experienced a 24% risk reduction in PFS compared to patients in the trastuzumab arm (HR=0.76, p=0.033). Notably, approximately 85% of patients in the study were carriers of the CD16A (Fc?RIIIa) 158F allele, which has been previously associated with diminished clinical response to HERCEPTIN and other antibodies.
• MacroGenics anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the second half of 2019.

A gene mutation that makes an excess of the HER-2 protein is present in about 15% of primary invasive breast cancers, according to UpToDate, an evidence-based medical resource used by clinicians. This particular trial showed longer progression-free survival in patients treated with a combination of margetuximab and chemotherapy compared to those on trastuzumab (brand name Herceptin) and chemotherapy, a standard-of-care treatment. The company also said approximately 85% of patients in the study were carriers of the CD16A 158F allele, a gene variation has been associated with a reduced clinical response to Herceptin and other antibodies. MacroGenics said it plans to submit a biologics license application to the U.S. Food and Drug Administration in the second half of 2019.

** charts before announcement **