Vizimpro for the first-line treatment of patients with EGFR-mutated metastatic non-small cell lung cancer, approved from FDA
The FDA ( U.S. Food and Drug Administration ) has approved Vizimpro ( Dacomitinib ), a kinase inhibitor 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.
The safety and efficacy of Vizimpro was demonstrated in ARCHER 1050, a randomized, multicenter, multinational, open-label study.
Patients were required to have 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 ECOG performance status of 0 or 1; EGFR exon 19 deletion or exon 21 L858R substitution mutations.
A total of 452 patients were randomized 1:1 to Dacomitinib ( n=227 ) or Gefitinib ( n=225 ).
The primary endpoint was progression-free survival ( PFS ) as determined by blinded Independent Radiologic Central ( IRC ) review, and additional efficacy outcomes included overall response rate ( ORR ), duration of response ( DoR ) and overall survival ( OS ).
A statistically significant improvement in progression-free survival as determined by the IRC was demonstrated for patients randomized to Dacomitinib compared with Gefitinib ( hazard ratio, HR = 0.59 [ 95% CI: 0.47, 0.74 ], p less than 0.0001 ).
Median progression-free survival in the Dacomitinib group was 14.7 months ( 95% CI: 11.1, 16.6 ) compared with 9.2 months ( 95% CI: 9.1, 11.0 ) in the Gefitinib arm.
EGFR-mutated advanced non-small cell lung cancer is a common illness, especially in the Asian population.
The findings from ARCHER 1050 suggest that Dacomitinib should be considered as a new first-line treatment option for patients with EGFR-mutated non-small cell lung cancer exon 19 deletion or exon 21 L858R substitution mutations.
Among 227 patients with EGFR-mutated metastatic NSCLC who received Dacomitinib in ARCHER 1050, the most common ( more than 20% ) adverse reactions were diarrhea ( 87% ), rash ( 69% ), paronychia ( 64% ), stomatitis ( 45% ), decreased appetite ( 31% ), dry skin ( 30% ), decreased weight ( 26% ), alopecia ( 23% ), cough ( 21% ), and pruritus ( 21% ).
Serious adverse reactions occurred in 27% of patients treated with Dacomitinib.
The most common ( greater than or equal to 1% ) serious adverse reactions reported were diarrhea ( 2.2% ) and interstitial lung disease ( 1.3% ). ( Xagena )
Source: Pfizer, 2018