According to a new study published in the journal The Lancet Oncology, researchers have found that dacomitinib, an irreversible pan-human epidermal growth factor receptor (pan-HER) tyrosine kinase inhibitor (TKI), was not effective at improving overall survival in patients with advanced non-small cell lung cancer (NSCLC) previously treated with chemotherapy and an epidermal growth factor (EGFR) TKI.
In the phase 3 double-blind, placebo-controlled study, researchers randomly assigned 720 patients to receive either dacomitinib or placebo. Patients treated with dacomitinib were followed for a median of 23.4 months and patients given placebo were followed for a median of 24.4 months.
They found that patients in the dacomitinib group had a median overall survival 6.83 months, while those in the placebo group had an overall survival of 6.21 months (HR 1.00 [95% CI 0.83-1.21]; P=0.506). Patients in the dacomitinib group had progression-free survival nearly twice as long as the placebo group (median 2.66 months versus 1.38 months, respectively; HR 0.66 [95% CI 0.55-0.79]; P<0.0001). Patients taking dacomitinib had a longer time to worsening of lung cancer symptoms than the placebo group.
The findings suggest that dacomitinib should not be recommended for the treatment of patients with advanced NSCLC previously treated with chemotherapy and an EGFR TKI.
The authors designed BR.26 to assess whether dacomitinib improved overall survival in heavily pretreated patients with this disease. Dacomitinib did not increase overall survival and cannot be recommended for treatment of patients with advanced non-small-cell lung cancer previously treated with chemotherapy and an EGFR tyrosine-kinase inhibitor.