Dacomitinib (daco) versus gefitinib (gef) for first-line treatment of advanced NSCLC (ARCHER 1050): Final overall survival (OS) analysis

Background:In the ongoing phase 3 ARCHER 1050 study, first-line treatment with daco significantly improved the primary endpoint of progression-free survival, duration of response, and time to treatment failure vs gef in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC) (Wu et al, Lancet Oncol, 2017). Here, we present the OS results.

Methods:Pts with newly diagnosed stage IIIB/IV or recurrent NSCLC harboring an EGFR mutation (exon 19 del or exon 21 L858R ± exon 20 T790M) and without central nervous system metastasis were randomized 1:1 to oral daco 45 mg/day or oral gef 250 mg/day. Pts were stratified by race and EGFR mutation type.

Results:As of 17 February 2017, a total of 220 deaths (48.7%) occurred over a median follow-up of 31.3 months (mo): 103 (45.4%) in the daco arm (n = 227) and 117 (52.0%) in the gef arm (n = 225). Daco showed a significant improvement in OS compared to gef (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.582–0.993; 2-sided P= 0.044 based on stratified analysis). Median OS (95% CI) was 34.1 mo (29.5–37.7) with daco vs 26.8 mo (23.7–32.1) with gef. Survival rates at 30 mo were 56.2% with daco and 46.3% with gef. The table shows preliminary OS subgroup analyses by race and EGFR mutation type, with >55% of pts being censored in some subsets. OS subgroup analyses were consistent with the primary OS analysis across most baseline characteristics.

Conclusions:In pts with advanced EGFR mutation-positive NSCLC, daco is the first to show a significant improvement in OS in a phase 3 trial compared with a standard-of-care tyrosine kinase inhibitor. Daco should be considered as one of the standard treatment options for these pts. Clinical trial information: NCT01774721

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