On September 27, 2018, the FDA approved dacomitinib (Vizimpro®, Pfizer) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R mutations as confirmed by an FDA-approved test.

ARCHER 1050

The multicenter, open-label, active-controlled ARCHER 1050 study (NCT01774721) randomised 452 patients with unresectable, metastatic NSCLC who did not receive prior treatment for metastatic disease or with recurrent disease ≥12 months after completion of systemic non-EGFR tyrosine kinase inhibitor (TKI)-containing therapy; a performance status of 0 or 1; and EGFR ex19del or L858R mutations. Participants were randomised 1:1 to receive either dacomitinib 45 mg orally (PO) once daily (QD) or gefitinib 250 mg PO QD until disease progression or unacceptable toxicity.

The median progression-free survival (PFS) by independent review committee IRC measured 14.7 in the dacomitinib group and 9.2 months in the gefitinib group (HR=0.59; 95% CI, 0.47-0.74; p<0.0001). No significant improvement in the overall response rate (ORR) or overall survival (OS) was reported.

Safety

The FDA approved label has warnings and precautions for interstitial lung disease (ILD), diarrhoea, and dermatologic adverse events (AEs). Data in 394 patients who have received dacomitinib indicate a serious AE (SAE) rate of 27%. The most common AEs resulting in discontinuation of dacomitinib-treatment were diarrhoea and ILD. Common AEs that occurred >20% of patients on dacomitinib were diarrhoea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

Prescribing information Vizimpro.