Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• Cohort D (previously treated, no human epidermal growth factor receptor 2 (HER2)–targeted therapy) had an objective response of 64% (95% confidence interval [CI], 53 to 75), median duration of response 9.2 months (95% CI, 6.3 to 13.5), and median progression-free survival 8.3 months (95% CI, 6.9 to 12.3).
• Cohort E (previously received HER2-directed antibody-drug conjugates) had an objective response of 38% (95% CI, 25 to 52), median duration of response 8.5 months, and median progression-free survival 5.5 months.
• Cohort F (no previous treatment) had an objective response of 71% (95% CI, 59 to 81), median duration of response 11.0 months, and data on progression-free survival were immature; objective response was higher in Cohort D than Cohort E (64% vs 38%), with longer median duration of response (9.2 vs 8.5 months) and progression-free survival (8.3 vs 5.5 months), and Cohort F had the highest objective response (71%) and longest median duration of response (11.0 months) among the three cohorts.
• Grade 3 or higher drug-related adverse events occurred in 31% of patients; diarrhea was the most common adverse event (84 to 91% of patients), with grade 3 or higher diarrhea in 5 to 23% of patients.
• Treatment discontinuation due to drug-related adverse events occurred in 3% of patients.