Non–Small Cell Lung Cancer

Initial US Approval

2018¹

Indications

First-line treatment of patients with metastatic NSCLC with epidermal growth EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.¹

Recommended Dose/Route

Dacomitinib 45 mg orally daily, with or without food, until disease progression or unacceptable toxicity occurs.¹

Dose Reductions for Adverse Reactions¹

1st dose reduction: 30 mg

2nd dose reduction: 15 mg

Pivotal Study

ARCHER 1050 (NCT01774721)²

Key Inclusion Criteria: Unresectable, metastatic NSCLC with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; EGFR exon 19 deletion or exon 21 L858R substitution mutations. EGFR mutation status was prospectively determined by local laboratory or commercially available tests.¹

Treatment

Dacomitinib 45 mg or gefitinib 250 mg once daily until disease progression or unacceptable toxicity.¹

Dacomitinib: Efficacy Data

Safety

The most common adverse reactions (>20%) were diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritis. Laboratory abnormalities worsening from baseline in ≥30% of patients were anemia, lymphopenia, hypoalbuminemia, increased ALT, hperglycemia, increased AST, and hypocalcemia.¹

Dosage Interruptions Due to AEs: 57%¹

Dosage Reductions Due to AEs: 66%¹

Permanent Discontinuation Due to AEs: 18%¹

References

1. Pfizer. Vizimpro (Dacomitinib). Package Insert. 2020. https://labeling.pfizer.com/ShowLabeling.aspx?id=11019

2. Wu Y-L, Cheng Y, Zhou X, et al. Dacomitinib versus defitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomized, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454-1466. doi: 10.1016/S1470-2045(17)30608-3