Results from the ARCHER 1009 Study: Dacomitinib Versus Erlotinib for Second-/Third-Line Therapy of Locally Advanced or Metastatic NSCLC
Dacomitinib (D) is an irreversible pan-HER kinase inhibitor that has been shown to be effective in patients with EGFR-activating mutations and in those with EGFR and KRAS wild-type (wt) NSCLC. In the ARCHER 1009 study, patients with locally advanced or metastatic NSCLC who had progressed on 1 or 2 prior chemotherapy regimens were randomized to receive D or erlotinib (E) with placebo controls for both arms (Ramalingam SS, et al. ASCO 2014. Abstract 8018). The primary end point was progression-free survival (PFS), with overall survival (OS), objective response rate (ORR), and safety as secondary outcomes. The 878 patients enrolled in the study included 69% with adenocarcinoma and 18% never-smokers. An activating EGFR mutation was present in 41 patients in each arm of the study. There were no statistically significant differences in ORR, median PFS, or median OS between D and E, both in all patients taken together and in the KRAS-wt group. Median PFS was 2.6 months with D and E among all patients and among the KRAS-wt patients. Median OS was 7.9 months with D and 8.4 months with E in all patients, and 8.1 months with D and 8.5 months with E in KRAS-wt patients. These types of negative studies are very useful in providing value-based cancer care in that they avoid the use of ineffective agents for specific patient populations, thus promoting safer value-based care.