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
The primary report of ARCHER 1050: dacomitinib held untreated EGFR-mutant lung cancer for a median of 14.7 months against 9.2 months on gefitinib, at the cost of more rash and diarrhoea.
Overview
International, multicentre, randomised, open-label phase 3 trial at 71 academic centres in seven countries or regions in adults with newly diagnosed advanced non-small-cell lung cancer and one EGFR mutation (exon 19 deletion or Leu858Arg). Patients were randomised 1:1 to oral dacomitinib 45 mg a day or gefitinib 250 mg a day, stratified by race and EGFR mutation type. The primary endpoint was progression-free survival by masked independent review in the intention-to-treat population.
Between May 2013 and March 2015, 452 patients were randomised (227 dacomitinib, 225 gefitinib). Median progression-free survival was 14.7 months (95% CI 11.1 to 16.6) with dacomitinib and 9.2 months (95% CI 9.1 to 11.0) with gefitinib (hazard ratio 0.59, 95% CI 0.47 to 0.74). The most common grade 3 to 4 adverse events on dacomitinib were dermatitis acneiform (14 percent) and diarrhoea (8 percent). Funded by SFJ Pharmaceuticals Group and Pfizer.
- Median progression-free survival 14.7 vs 9.2 months by masked independent review; hazard ratio 0.59 (95% CI 0.47 to 0.74).
- 452 patients randomised between May 2013 and March 2015; median follow-up for progression-free survival 22.1 months.
- Grade 3 to 4 dermatitis acneiform in 14% and diarrhoea in 8% on dacomitinib.
ARCHER 1050 supported dacomitinib's 2018 US first-line approval and was the first head-to-head win of a second-generation EGFR inhibitor over a first-generation one on progression-free survival. FLAURA, reported the same year, made osimertinib the usual first choice, so dacomitinib is now rarely used.
- Open-label; patients with brain metastases were excluded, so the result does not speak to the commonest site of EGFR-mutant relapse.
- Overall survival was reported separately (Mok 2018).
- Dose reductions were needed in two thirds of dacomitinib patients according to the US label.
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