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The mature survival analysis of ARCHER 1050: patients on dacomitinib lived a median of 34.1 months against 26.8 months on gefitinib, the first survival gain for a second-generation EGFR inhibitor over a standard one.
Mature overall survival analysis of the intention-to-treat population of ARCHER 1050, the randomised, open-label phase 3 trial of dacomitinib (227 patients) versus gefitinib (225) in treatment-naive advanced non-small-cell lung cancer with an EGFR exon 19 deletion or exon 21 L858R mutation, stratified by race and EGFR mutation type. The final analysis had a data cut-off of 17 February 2017, when 220 deaths (48.7 percent) had occurred.
During a median follow-up of 31.3 months there were 103 deaths (45.4 percent) on dacomitinib and 117 (52.0 percent) on gefitinib. The hazard ratio for overall survival was 0.760 (95% CI 0.582 to 0.993; two-sided P = .044). Median overall survival was 34.1 months with dacomitinib versus 26.8 months with gefitinib, and 30-month survival was 56.2 and 46.3 percent. Preliminary subgroup analyses were consistent with the primary analysis.
This is the separate paper behind the survival figure quoted for dacomitinib. It is a real but modest gain, and the US label notes that overall survival was not formally tested because the response rate comparison earlier in the testing order was not significant, so the P value is descriptive.
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.