Pfizer reports Phase III PFS data for dacomitinib in first-line NSCLC

Pfizer Inc. (NYSE:PFE) reported data from the Phase III ARCHER 1050 trial in 452 patients with locally advanced or metastatic, EGFR mutation-positive non-small cell lung cancer (NSCLC) without CNS metastasis showing that first-line treatment with once-daily 45 mg oral dacomitinib (PF-00299804) led to an independent review committee (IRC)-assessed median progression-free survival (PFS) of 14.7 months vs. 9.2 months for Iressa gefitinib (HR=0.59, 95% CI: 0.47, 0.74, 1-sided p<0.0001). By investigator assessment, dacomitinib led to a median PFS of 16.6 months vs. 11 months for Iressa (HR=0.62, 95% CI: 0.5, 0.78, 1-sided p<0.0001). Additionally, dacomitinib led to an objective response rate (ORR) of 74.9% vs. 71.6% for Iressa (p=0.3883). Median duration of response was 14.8 months for dacomitinib vs. 8.3 months for Iressa (1-sided p<0.0001). Overall survival (OS) data are not yet mature. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

IRC-assessed PFS is the open-label, international trial’s primary endpoint. Secondary endpoints include investigator-assessed PFS, ORR, duration of response, time to treatment failure, OS, safety and patient-reported outcomes...