Looking ahead to the week of May 31 to June 4, one of the biggest health care conferences of the year, the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) takes place in Chicago. This meeting always brings big swings in the health care sector, whether positive or negative. As we have said before, the results presented at this meeting have the potential to make or break these companies.
MacroGenics Inc. (NASDAQ: MGNX) announced additional details of the results from the Phase 3 Sophia study of margetuximab in patients with HER2-positive metastatic breast cancer who have previously been treated with anti-HER2-targeted therapies. Margetuximab is an investigational, immune-enhancing monoclonal antibody derived from the company’s proprietary Fc Optimization technology platform.
The study met its first sequential primary endpoint of progression-free survival (PFS). The median PFS of patients treated with margetuximab and chemotherapy was 5.8 months, compared to 4.9 months in patients treated with trastuzumab and chemotherapy.
Among the approximately 85% of patients carrying the CD16A 158F allele, a pre-specified exploratory subpopulation in the study, PFS was prolonged by 1.8 months in the margetuximab arm compared to the trastuzumab arm (6.9 months versus 5.1 months).
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The objective response rate, a secondary outcome measure in the Sophia study, was 22% in the margetuximab arm, compared to 16% in the trastuzumab arm.
Hope S. Rugo, M.D., Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Comprehensive Cancer Center, commented:
With no FDA-approved therapies after progression on trastuzumab, pertuzumab, and ado-trastuzumab emtansine, patients with HER2-positive metastatic breast cancer continue to need new treatment options. If approved, based on Sophia data, I believe that margetuximab could become a valuable treatment option for these patients.
Shares of MacroGenix were last seen up about 9% at $17.80, in a 52-week range of $9.87 to $32.32. The consensus price target is $34.36.
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