MacroGenics (NASDAQ:MGNX) submitted a biologics license application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer.
The submission is based on the safety and efficacy results of the Phase 3 SOPHIA study, which enrolled 536 patients who received either 15 mg/kg IV margetuximab or 6 mg/kg IV trastuzumab every three weeks, in combination with one of four chemotherapy agents.
The trial’s primary endpoints are sequentially-assessed progression-free survival (PFS) and overall survival (OS). The trial met its first sequential PFS endpoint in May 2019. MacroGenics recently reported that the trial’s second interim OS analysis favored margetuximab plus chemotherapy compared with trastuzumab and chemotherapy in the intention-to-treat population, but did not reach statistical significance.
“We believe the positive clinical trial results in SOPHIA demonstrate margetuximab’s potential as a treatment option for patients living with this devastating disease,” Dr. Scott Koenig, MacroGenics’ president and CEO, said in a statement.
A final OS analysis is planned after 385 events and is expected to occur in the second half of 2020.
