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The MARGOT/TBCRC052 trial failed to show a significant improvement in pathologic complete response (pCR) rates with margetuximab compared with trastuzumab in patients with early-stage HER2-positive breast cancer (BC) carrying the CD16A F allele. Treatment with margetuximab was well tolerated, and the increased rate of infusion-related reactions were manageable.
Adrienne Waks, MD, Dana-Farber Cancer Institute, Massachusetts presented the results of the randomized phase 2 MARGOT/TBCRC052 trial (NCT04425018)1. This study followed the phase 3 SOPHIA trial (NCT02492711), in which margetuximab demonstrated improved outcomes over trastuzumab in patients with HER2-positive metastatic BC carrying the CD16A F allele2. The primary objective of the MARGOT/TBCRC052 trial was to investigate whether margetuximab was more effective than trastuzumab in patients with early-stage HER2-positive BC carrying the CD16A F allele1.
The eligibility criteria included patients with stage II-III HER2-positive BC of any hormone receptor status, were treatment-naïve, and had a CD16A genotype FF or FV. The study enrolled 171 participants, with a median age of 52 to 55 years. Approximately 80% of participants had clinical T2 tumors, 63–69% were staged N0, and approximately 85% were clinical stage II. About 63–69% had a positive hormone receptor status, and approximately 50% had a CD16A genotype FF or FV. The participants were randomly assigned in a 2:1 ratio to receive either neoadjuvant paclitaxel/margetuximab/pertuzumab (TMP) or neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP).
Dr. Waks concluded that “no statistically significant improvement in pCR rate was seen with TMP compared with THP,” but noted that “a numerical improvement in pCR rate (10% delta; P=0.25) with TMP was observed, which will be further investigated through comparison of circulating and tissue immune biomarkers across the two arms.” Both treatment regimens were well tolerated, and the increased rates of infusion-related reactions in the TMP arm were manageable.
Medical writing support was provided by Kulsoom Abdul.
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