Real-world use of and clinical outcomes with dacomitinib as first-line therapy in Asian patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer: Final analysis of the ARIA study.

BACKGROUND

Dacomitinib, a second-generation, irreversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR), showed statistically significant progression-free survival improvement over gefitinib in patients with treatment-naive EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) in the phase 3 ARCHER 1050 study (NCT01774721). We report results from the final analysis of ARIA (NCT04609319), a noninterventional study of dacomitinib's real-world utilization and associated clinical outcomes in Asian patients with EGFR mutation-positive advanced NSCLC.

METHODS

This longitudinal, multicenter cohort study collected prospective and retrospective data from patients with EGFR mutation-positive locally advanced or metastatic NSCLC who were treated with first-line dacomitinib. Study objectives were to describe clinical and disease characteristics, therapeutic patterns of dacomitinib use, and clinical outcomes.

RESULTS

299 patients located in China (n = 261), India (n = 24), and Malaysia (n = 14) were enrolled and included in the analysis. Starting dose was 30 mg once daily in 159 (53.2 %) patients, 45 mg once daily in 138 (46.2 %), and other doses in 2 (0.7 %). As of May 28, 2024, 95 patients (31.8 %) had dose reductions, 47 (15.7 %) had dose increases, 41 (13.7 %) had dose interruptions, and 223 (74.6 %) had permanently discontinued dacomitinib. Median duration of treatment was 17.2 months (IQR, 19.2). Median time to treatment failure was 17.0 months (95 % CI, 14.5-19.8). Median progression-free survival was 20.1 months (95 % CI, 17.4-22.4). 148 (49.5 %) patients had treatment-related adverse events; most common were rash (n = 93 [31.1 %]), diarrhea (n = 81 [27.1 %]), and paronychia (n = 57 [19.1 %]).

CONCLUSIONS

To our knowledge, ARIA is the largest real-world study of dacomitinib's efficacy and safety. Final analysis of this study showed substantial clinical efficacy of dacomitinib and revealed treatment patterns, such as starting dose, in the real world. Safety data were consistent with dacomitinib's known safety profile. These results support first-line dacomitinib use in Asian patients with EGFR mutation-positive advanced NSCLC.

CLINICALTRIALS: gov NCT04609319.