EU approves Vizimpro for EGFR non-small cell lung cancer

Pfizer announced that the European Commission has approved Vizimpro (dacomitinib), a tyrosine kinase inhibitor (TKI), 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. The European Commission’s approval of Vizimpro was supported by data from ARCHER 1050, a randomized, multicenter, multinational, open-label, Phase III study conducted in patients with unresectable, metastatic or recurrent NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations.

A total of 452 patients were randomized 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250 mg (n=225). The primary endpoint was progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review. Key secondary endpoints included PFS assessed by the investigator, objective response rate (ORR), duration of response (DoR) and overall survival (OS). A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to Vizimpro compared with gefitinib. Median PFS in the Vizimpro group was 14.7 months compared with 9.2 months in the gefitinib arm.

Among 227 patients with EGFR-mutated metastatic NSCLC who received Vizimpro in ARCHER 1050, the most common (at least 20%) adverse reactions were diarrhea (87%), rash (77%), stomatitis (70%), nail disorder (66%), decreased appetite (31%), dry skin (30%), weight decreased (26%), transaminases increased (24%), conjunctivitis (23%), alopecia (23%), and pruritus (20%). Serious adverse reactions occurred in 6.2 percent of patients treated with Vizimpro. The most common (at least 1%) serious adverse reactions reported were diarrhea (2.2%) and interstitial lung disease (1.3%).