Summary

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• Nerlynx (neratinib maleate) is indicated as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy. It is also indicated in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
• This summary is based on the review of six systematic review(s)/meta-analysis(es). ^[1-6]
• Progression-Free Survival (PFS): Neratinib alone was associated with less favorable PFS compared to several other regimens, including pyrotinib + capecitabine, T-DM1, and trastuzumab-based therapies. However, it was ranked best for reducing CNS disease progression in HER2-positive breast cancer brain metastasis patients.
• Overall Survival (OS): Neratinib alone showed the worst OS benefits in comparison to other regimens like pyrotinib + capecitabine and T-DM1. It did not rank first in OS among the various regimens evaluated.
• Overall Response Rate (ORR): Neratinib did not show a significant difference in ORR when compared to other regimens, with T-DM1 showing a more favorable ORR.
• No significant difference in grade ≥3 adverse events (AEs) was observed among all regimens, including neratinib. However, dual therapy with neratinib was associated with increased toxicity, though no increase in cardiotoxicity was noted.
• T-DM1 had a more favorable safety profile compared to neratinib, with fewer discontinuations due to AEs and a different AE profile, including a lower likelihood of gastrointestinal side effects but a higher likelihood of elevated liver transaminases and thrombocytopenia.
• There is no population types or subgroups information available in the reviewed studies.