Vizimpro as first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending Vizimpro ( Dacomitinib ), as monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer ( NSCLC ) with epidermal growth factor receptor ( EGFR )-activating mutations.
Vizimpro was approved by the U.S. Food and Drug Administration ( FDA ) in 2018 for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
The Marketing Authorization Application ( MAA ) for Vizimpro was based on results from ARCHER 1050, a randomized, multicenter, multinational, open-label, phase 3 study conducted in patients with locally advanced unresectable, or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations, an ECOG performance status of 0 or 1; with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy.
A total of 452 patients were randomized 1:1 to Dacomitinib 45 mg ( n=227 ) or Gefitinib 250 mg ( n=225 ).
Randomization was stratified by region and EGFR mutation status.
The primary endpoint of the study was progression-free survival ( PFS ) as determined by blinded Independent Radiology Central ( IRC ) review.
Key secondary endpoints included objective response rate ( ORR ), duration of response ( DoR ), overall survival ( OS ), and patient-reported outcomes ( PROs ).
The benefits with Vizimpro are its ability to increase progression free survival compared with gefitinib.
The most common side effects are diarrhoea, rash, stomatitis, nail disorder, dry skin, decreased appetite, conjunctivitis, weight loss, alopecia, pruritus, increased transaminases and nausea.
Dacomitinib is an oral, once-daily, irreversible pan-human epidermal growth factor receptor kinase inhibitor for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer ( NSCLC ) with epidermal growth factor receptor ( EGFR )-activating mutations. ( Xagena )
Source: Pfizer, 2019