Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR-activating mutations
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.
Overview
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.
- Median overall survival 34.1 vs 26.8 months; hazard ratio 0.760 (95% CI 0.582 to 0.993), two-sided P = .044.
- Overall survival at 30 months 56.2% with dacomitinib and 46.3% with gefitinib.
- 220 deaths (48.7%) at the final analysis cut-off of 17 February 2017, after a median follow-up of 31.3 months.
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.
- Overall survival was not formally tested in the prespecified hierarchy (US label); the result is supportive rather than confirmatory.
- The confidence interval's upper bound (0.993) is close to one.
- Same open-label trial population as the primary paper, with brain metastases excluded.
Similar pages
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