Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 20 mg, 30 mg, 40 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test
- Indicated for the treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy.
Latest News
Summary
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- Obinutuzumab combined with acalabrutinib (O-acala) demonstrated the best progression-free survival (PFS) ranking in chronic lymphocytic leukemia (CLL), particularly in patients with del17/P53mut mutations, with SUCRA scores of 93.5% for aCD20-ibrutinib and 91% for O-acala; acalabrutinib plus obinutuzumab improved PFS compared to ibrutinib-obinutuzumab and venetoclax-obinutuzumab, with relative risks (RRs) of 0.43 and 0.29, respectively.
- In patients with follicular lymphoma, the combination of obinutuzumab, bendamustine, and maintenance obinutuzumab (G-Benda-G) resulted in the best PFS, achieving a hazard ratio (HR) of 0.41 compared to rituximab-bendamustine (R-Benda), with a SUCRA of 0.97 and a probability of being the best treatment (PbBT) of 72%.
- Patients with high-risk genetic features in CLL, such as TP53 aberrations and immunoglobulin heavy chain variable region (IGHV) unmutated status, showed similar PFS across different targeted agents. However, those with unmutated IGHV status had better PFS with acalabrutinib plus obinutuzumab compared to venetoclax plus obinutuzumab.
- Afatinib was noted for its effectiveness in patients with uncommon epidermal growth factor receptor (EGFR) mutations, demonstrating a higher objective response rate (ORR) of 60.6% compared to osimertinib at 50.3%, although this difference was not statistically significant. Afatinib also showed significantly superior PFS (11.0 months vs. 7.0 months) in these patients.
- Afatinib demonstrated a lower risk for hepatotoxicity compared to gefitinib and erlotinib, with gefitinib and erlotinib associated with a higher incidence of all-grade and high-grade alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations.
- Afatinib had a greater overall toxicity profile compared to icotinib but was less toxic than dacomitinib. Gefitinib, erlotinib, and icotinib showed higher incidences of rash and diarrhea.
- In the treatment of severe adverse events, afatinib was associated with rare occurrences of interstitial lung disease, dyspnea, and pneumonia. However, a reduced dose of 30 mg resulted in a lower incidence of severe diarrhea and rash while maintaining similar efficacy in patients without brain metastasis.
- East Asian patients with advanced non-small cell lung cancer (NSCLC) demonstrated superior PFS and overall survival (OS) with afatinib compared to other epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), particularly in patients with brain metastasis, where afatinib outperformed gefitinib.
- Elderly patients (aged >65 years) receiving afatinib showed longer PFS compared to those treated with gefitinib and erlotinib, specifically among those with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Patients with uncommon EGFR mutations experienced superior PFS with afatinib versus osimertinib, particularly in those with non-ex20ins single uncommon mutations, highlighting the efficacy of afatinib in this subgroup.
- Patients with type 2 diabetes mellitus (T2DM) benefited more from MET-EGFR-TKIs in terms of OS compared to non-diabetic patients, indicating a potentially enhanced treatment response in this population.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Gilotrif (afatinib) Prescribing Information. | 2022 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Non-small cell lung cancer treatment (PDQ®)–Health professional version. | 2024 | National Cancer Institute |
Oncogene-addicted metastatic non-small-cell lung cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. | 2023 | Annals of Oncology |
Non–small cell lung cancer, version 3.2022. | 2022 | Journal of National Comprehensive Cancer Network |
Japanese lung cancer society guidelines for stage IV NSCLC with EGFR mutations. | 2021 | JTO Clinical and Research Reports |
Metastatic non-small cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2020 | European Society for Medical Oncology |