MacroGenics shares soar on rosy Phase 3 trial for breast cancer drug

Shares of MacroGenics Inc (NASDAQ:MGNX) soared Wednesday in the wake of the unveiling of rosy results from its Phase 3 trial SOPHIA, which evaluated the effect of its drug margetuximab on HER2-positive metastatic breast cancer.

In a statement, the Rockville, Maryland-based biopharma company said the SOPHIA trial met the primary endpoint demonstrating that treatment with margetuximab as well as chemotherapy produced a statistically significant improvement in progression-free survival when measured against Roche’s trastuzumab plus chemotherapy.

“Patients in the margetuximab arm experienced a 24% risk reduction in progression-free survival compared to patients in the trastuzumab arm,” the statement said.

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In response, MacroGenics shares doubled before the opening bell to hit $22.98.

About 85% of patients who took part in the study were carriers of the CD16A (FcyRIIIa) 158F allele, which is associated with a diminished response to Herceptin and other antibodies.

Thanks to the success of the trial, MacroGenics plans to file a biologics license application for margetuximab to the US Food and Drug Administration in the second half of the year.

Margetuximab is a monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2 oncoprotein, which surfaces in breast, gastroesophageal and other solid tumors. MacroGenics is also developing Margetuximab in combination with anti-PD-1 therapy for the treatment of gastroesophageal cancer.

If margetuximab is approved, based on SOPHIA data, I believe that this agent could become a valuable treatment option for these patients,” said Dr. Hope Rugo, a director with Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center.

Results of the SOPHIA study are also being prepared for publication and a presentation later this year at a major scientific conference.

The SOPHIA study enrolled 536 patients at about 200 trial sites across North America, Europe and Asia. Patients were treated with either margetuximab or trastuzumab in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine).

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors