Drug updated on 12/11/2024
Dosage Form | Tablets (oral; 40 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumabbased therapy
- 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.
Latest News
Summary
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Tucatinib combined with trastuzumab and capecitabine (TTC) demonstrated an ORR of 47.3% in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer and brain metastases. Trastuzumab deruxtecan (T-DXd) achieved a pooled overall response rate (ORR) of 64% (95% confidence interval (CI): 43-85%) in heavily pretreated patients with asymptomatic brain metastases, outperforming other therapies like lapatinib and capecitabine, which had a higher risk of bias.
- For progression-free survival (PFS) and overall survival (OS), tucatinib plus trastuzumab with capecitabine ranked highest, showing superior outcomes compared to other HER2-directed therapies in unresectable or metastatic HER2+ breast cancer. T-DXd ranked first for PFS (hazard ratio (HR) 0.17; 95% credible interval (CrI) 0.03-0.82), while ado-trastuzumab emtansine (T-DM1) ranked first for OS in patients with HER2+ breast cancer brain metastases.
- In early HER2+ breast cancer, trastuzumab-based dual anti-HER2 therapy, especially when combined with pertuzumab, significantly improved event-free survival (EFS) and OS, with pronounced benefits seen in lymph node-positive subgroups.
- Trastuzumab-based dual anti-HER2 therapy was associated with a higher risk of cardiotoxicity, particularly when combined with pertuzumab (the surface under the cumulative ranking (SUCRA) of 92%), whereas lapatinib-containing regimens showed more general toxicity but no significant increase in cardiotoxicity.
- Neratinib-containing regimens were generally well-tolerated but showed no significant safety concerns compared to other HER2-targeted therapies, particularly in the management of CNS disease progression.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nerlynx (neratinib) Prescribing Information. | 2022 | Puma Biotechnology, Inc., Los Angeles, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Systemic therapy for advanced human epidermal growth factor receptor 2–positive breast cancer: ASCO guideline update | 2022 | Journal of Clinical Oncology |
Neratinib for extended adjuvant treatment of hormone receptor-positive, HER2-positive early stage breast cancer after adjuvant trastuzumab | 2019 | National Institute for Health and Excellence |