NALA
NALA showed that the irreversible HER2 inhibitor neratinib, given with capecitabine, kept heavily pretreated HER2-positive breast cancer under control for longer than lapatinib and reduced the need for treatment of brain metastases.
Overview
NALA randomised 621 patients with HER2-positive metastatic breast cancer who had received two or more prior HER2-directed regimens to neratinib plus capecitabine or lapatinib plus capecitabine. The co-primary endpoints were progression-free and overall survival.
Neratinib improved progression-free survival, with a smaller and non-significant difference in overall survival, and fewer patients needed intervention for central nervous system metastases. Diarrhoea was the dominant toxicity and requires prophylaxis. The regimen was approved in the United States in February 2020 for third-line or later HER2-positive metastatic disease.
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