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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.
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.
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.
Shares Dacomitinib, Tony S. K. Mok, ARCHER 1050, Yi-Long Wu.
Shares Dacomitinib, Pfizer (incl. Seagen), Non-small-cell lung cancer.
Shares Dacomitinib, EGFR-mutated non-small-cell lung cancer, Non-small-cell lung cancer.
Shares Gefitinib, EGFR-mutated non-small-cell lung cancer, EGFR, Non-small-cell lung cancer.
Shares ARCHER 1050, Gefitinib, EGFR-mutated non-small-cell lung cancer, EGFR.
Shares Tony S. K. Mok, Gefitinib, EGFR-mutated non-small-cell lung cancer, EGFR.
Shares ARCHER 1050, Gefitinib, EGFR-mutated non-small-cell lung cancer, EGFR.
Shares Yi-Long Wu, EGFR-mutated non-small-cell lung cancer, EGFR, Non-small-cell lung cancer.