Summary

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• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• Margetuximab demonstrated a median overall survival (OS) of 21.6 months, which was comparable to trastuzumab, with no statistically significant difference between the two (95% confidence interval (CI) (hazard ratio (HR)), 0.95; 95% CI, 0.77-1.17; P = .620).
• Margetuximab showed an improvement in progression-free survival (pooled data: HR 0.39 (95% CI 0.29, 0.53 (PFS)) over trastuzumab, reducing the relative risk of progression by 24% (HR, 0.76; 95% CI, 0.59-0.98; P = .03), with a median PFS of 5.8 months versus 4.9 months for trastuzumab.
• Objective response rates (ORR) for margetuximab were higher than trastuzumab, with margetuximab achieving 22%-25% versus 14%-16% for trastuzumab (P < .001 at some time points). Subgroup analysis indicated potential benefits for patients with the CD16A-158FF genotype.
• Margetuximab demonstrated a comparable overall safety profile to trastuzumab, with the primary difference being a higher incidence of infusion-related reactions in margetuximab-treated patients (13.3% vs. 3.4%). These reactions were mostly observed during the first treatment cycle.
• No other significant differences in adverse effects were noted between margetuximab and trastuzumab, indicating that both drugs generally share a similar safety profile beyond the higher rate of infusion-related reactions associated with margetuximab.
• An exploratory analysis showed that in patients with the CD16A-158FF genotype, margetuximab may provide a potential OS benefit compared to trastuzumab (median OS, 23.6 vs. 19.2 months; HR, 0.72; 95% CI, 0.52 to 1.00). In contrast, patients with the CD16A-158VV genotype may experience better OS with trastuzumab (median OS, 31.1 vs. 22.0 months; HR, 1.77; 95% CI, 1.01 to 3.12).