Dacomitinib

(Vizimpro®)

Dacomitinib

Drug updated on 9/4/2024

Dosage FormTablet (oral; 15 mg, 30 mg, 45 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test

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Summary
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  • Vizimpro (dacomitinib) is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Progression-Free Survival (PFS): Dacomitinib demonstrated promising efficacy in patients with major uncommon EGFR mutations (G719X, S768I, L861Q), specific subtypes of EGFR exon 20 insertion mutations, and HER2 exon 20 insertion mutation, showing superior PFS in Asian patients with EGFR-mutated NSCLC compared to standards of care (HR = 0.62). However, it ranked lower than osimertinib and certain combination therapies for PFS in patients with or without brain metastases.
  • Overall Survival (OS): Dacomitinib ranked among the top four treatment strategies for OS in first-line settings with a SUCRA score of 0.79 but did not show significant OS benefits in Asian patients with the EGFR 19del mutation when compared to other treatments like bevacizumab plus chemotherapy and osimertinib.
  • Disease Control Rate (DCR) and Objective Response Rate (ORR): While specific DCR and ORR data for dacomitinib were not detailed, it demonstrated good disease control for uncommon EGFR mutations. Comparatively, erlotinib plus bevacizumab and erlotinib plus ramucirumab showed superior ORR.
  • Specific adverse events or safety concerns for dacomitinib were not detailed, but it showed fewer grade ≥3 adverse events compared to combination therapies such as erlotinib plus bevacizumab and gefitinib plus pemetrexed-based chemotherapy.
  • Osimertinib ranked highest for avoiding severe adverse events, with fewer grade ≥3 adverse events compared to other drugs, including dacomitinib. Combination therapies generally caused the most grade ≥3 adverse events, indicating higher toxicity, especially in Asian patients with EGFR 19del mutation.
  • There is a potential benefit of combining dacomitinib with olaparib in patients with osimertinib-resistant brain and leptomeningeal metastases.

Product Monograph / Prescribing Information

Document TitleYearSource
Vizimpro (dacomitinib) Prescribing Information.2020Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The treatment of patients with non-small cell lung cancer carrying uncommon EGFR mutations, HER2 mutations, or brain metastases: a systematic review of pre-clinical and clinical findings for dacomitinib. 2023Translational Cancer Research
Comparison of the efficacy and safety of first-line treatments for of advanced EGFR mutation-positive non-small-cell lung cancer in Asian populations: a systematic review and network meta-analysis.2023Frontiers in Pharmacology
Front-line therapy for brain metastases and non-brain metastases in advanced epidermal growth factor receptor-mutated non-small cell lung cancer: a network meta-analysis.2023Chinese Medical Journal
Overall survival benefits of first-line treatments for Asian patients with advanced epidermal growth factor receptor-mutated NSCLC harboring exon 19 deletion: a systematic review and network meta-analysis.2022Cancers
Overall survival benefits of first-line treatments for Asian patients with advanced EGFR-mutated NSCLC harboring L858R mutation: a systematic review and network meta-analysis.2022JTO Clinical Research and Reports
Olaparib combined with dacomitinib in osimertinib-resistant brain and leptomeningeal metastases from non-small cell lung cancer: a case report and systematic review.2022Frontiers in Oncology
Efficacy and safety of first line treatments for patients with advanced epidermal growth factor receptor mutated, non-small cell lung cancer: systematic review and network meta-analysis.2019British Medical Journal

Clinical Practice Guidelines