Dacomitinib Improves PFS vs Gefitinib in Non-small Cell Lung Cancer

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For this open-label phase 3 study, researchers enrolled 452 patients to receive dacomitinib or gefitinib.
For this open-label phase 3 study, researchers enrolled 452 patients to receive dacomitinib or gefitinib.

Among patients with EGFR­-positive, non–brain metastatic non–small cell lung cancer (NSCLC), first-line dacomitinib improves progression-free survival (PFS) over gefitinib, according to a phase 3 study published in The Lancet Oncology.1

First-generation EGFR–tyrosine kinase inhibitors (TKIs), including gefitinib, are used in the first line for patients with EGFR­-position disease, which constitute between 10% and 44% of all lung adenocarcinomas. Previous study has not determined whether second-generation EGFR-TKIs are superior to the first-generation variety.

For this open-label, randomized study (ARCHER 1050; ClinicalTrials.gov Identifier: NCT01774721), which the authors noted is the first phase 3 study to compare a second-generation EGFR-TKI with a first-generation EGFR-TKI in this setting, researchers enrolled 452 patients to receive dacomitinib (227 patients) or gefitinib (225 patients). Patients with brain metastases were not eligible.

At a median follow-up of 22.1 months, median PFS was 14.7 months for dacomitinib vs 9.2 months for gefitinib; subgroup analyses also favored dacomitinib. Twelve complete responses were recorded in the dacomitinib group vs 4 in the gefitinib group.

The objective response rates were, however, similar (75% for dacomitinib and 72% for gefitinib; P = .4234).

Twenty-one patients receiving dacomitinib had a serious treatment-related adverse event (AE); this was true of 10 patients receiving gefitinib. Treatment-related deaths were reported for 2 patients receiving dacomitinib vs 1 for gefitinib.

The authors concluded that “dacomitinib treatment was superior to gefitinib with respect to [PFS] and duration of response in the first-line treatment of patients with EGFR-mutation-positive NSCLC and should be considered as a new treatment option for this population.”


  1. Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Sep 25. doi: 10.1016/S1470-2045(17)30608-3 [Epub ahead of print]

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