Drug updated on 9/4/2024
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.
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Summary
- Gilotrif (afatinib) is 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, and for the treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy.
- This summary is based on the review of 14 systematic review(s)/meta-analysis(es). [1-14]
- Overall Survival (OS): Afatinib significantly improved OS in NSCLC (HR: 0.86; 95% CI: 0.76-0.97) and R/M HNSCC (HR: 0.89; 95% CI: 0.81-0.98).
- Progression-Free Survival (PFS): Afatinib improved PFS in NSCLC (HR: 0.75; 95% CI: 0.66-0.84) and R/M HNSCC (HR: 0.76; 95% CI: 0.65-0.88), with a more profound benefit observed in patients with uncommon EGFR mutations (11.0 vs. 7.0 months, P = 0.044).
- Objective Response Rate (ORR): Afatinib demonstrated a higher ORR compared to osimertinib in patients with non-ex20ins single uncommon EGFR mutations (60.6% vs. 50.3%) and maintained consistently high ORRs in specific compound mutations.
- Comparison with Other Drugs: Osimertinib, dacomitinib, and combination therapies generally outperformed afatinib in PFS, particularly in patients with specific mutations, though afatinib remained effective for certain uncommon mutations.
- Common Adverse Events: Afatinib was associated with grade 3/4 adverse events such as rash and diarrhea, with fewer severe adverse events than combination therapies. Other drugs, particularly combination therapies like erlotinib plus bevacizumab, had the highest incidence of grade ≥3 adverse events, while icotinib and osimertinib had the fewest.
- Serious Adverse Events: Afatinib-related serious adverse events included rare cases of interstitial lung disease, dyspnea, pneumonia, acute renal failure, and renal injury. Erlotinib and gefitinib were associated with higher rates of T790M mutations, indicating greater resistance potential compared to afatinib.
- Safety Comparison: Afatinib and dacomitinib exhibited higher toxicity levels compared to other TKIs, with combination treatments showing more toxicity than monotherapies. Dose adjustments for afatinib (from 40 mg to 30 mg) significantly reduced severe diarrhea and rash incidence.
- There is no population type or subgroup information available in the reviewed studies.
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 |