FDA has approved Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
Vizimpro is sponsored by Pfizer.
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 Eastern Cooperative Oncology Group 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 Vizimpro (n=227) or gefitinib (n=225). The primary endpoint was progression-free survival as determined by blinded Independent Radiologic Central review, and additional efficacy outcomes included overall response rate, duration of response (DoR) and overall survival.
A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to Vizimpro compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p <0.0001). Median PFS in the Vizimpro 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, and new treatment options will ultimately benefit patients,” said Tony Mok, primary investigator for the ARCHER 1050 study and chair of Department of Clinical Oncology, The Chinese University of Hong Kong. “The findings from ARCHER 1050 suggest that Vizimpro 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 Vizimpro in ARCHER 1050, the most common (> 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 percent of patients treated with Vizimpro. The most common (≥1%) serious adverse reactions reported were diarrhea (2.2%) and interstitial lung disease (1.3%). The full prescribing information for Vizimpro can be found here.
In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative development agreement to conduct ARCHER 1050 across multiple sites.
SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies. Under this agreement, SFJ Pharmaceuticals provided the funding and conducted the trial to generate the clinical data used to support this application.
Pfizer retains all rights to commercialize Vizimpro globally.
