ASCO 2018: Final Overall Survival Results With Dacomitinib vs. Gefitinib in NSCLC
Posted: Wednesday, June 13, 2018
The first treatment to offer an overall survival benefit over standard-of-care tyrosine kinase inhibitor therapy in patients with advanced EGFR mutation–positive non–small cell lung cancer (NSCLC) is dacomitinib, according to Abstract 9004 presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Lead author Tony Mok, MD, FASCO, of The Chinese University of Hong Kong, and colleagues previously published their results in The Lancet Oncology, describing dacomitinib’s significant effects (vs. gefitinib) on progression-free survival, duration of response, and time to treatment failure in this patient population.
“These data are particularly significant as dacomitinib is the first EGFR tyrosine kinase inhibitor in a phase III head-to-head study comparing two tyrosine kinase inhibitors to show an improvement in overall survival,” stated Dr. Mok in an ASCO press release.
In the phase III ARCHER 1050 study, patients with advanced EGFR mutation–positive NSCLC, but no central nervous system metastasis, were randomized to receive oral dacomitinib at 45 mg/day (n = 227) or oral gefitinib at 250 mg/day (n = 225). After a median follow-up of 31.3 months, 220 deaths had occurred, 103 (45.4%) in the dacomitinib arm and 117 (52.0%) in the gefitinib arm; this represents a “significant” overall survival advantage for dacomitinib (P = .044). Median overall survival rates were 34.1 months and 26.8 months for the dacomitinib and gefitinib arms, respectively.
Of note, median overall survival with both dacomitinib and gefitinib was found to be better in Asian patients than non–East Asian patients. With dacomitinib, median overall survival was 34.2 months in Asian patients, compared with 29.5 months in non–East Asian patients. With gefitinib, median overall survival was 29.1 months in Asian patients, compared with 20.6 months in non–East Asian patients.