Pfizer announces OS improvement in dacomitinib compared to gefitinib at ASCO
Pfizer announced overall survival, or OS, data from the ARCHER 1050 trial evaluating dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer, or NSCLC, with EGFR-activating mutations compared to gefitinib. The trial showed a median OS of 34.1 months for patients receiving dacomitinib, representing a more than seven-month improvement compared to 26.8 months with gefitinib. The OS data from ARCHER 1050 were presented as an oral presentation at the 54th Annual Meeting of the American Society of Clinical Oncology, or ASCO. Overall survival was a secondary endpoint of ARCHER 1050, a randomized, open label Phase 3 study comparing the efficacy and safety of dacomitinib to gefitinib for the first-line treatment of locally advanced or metastatic NSCLC in subjects with EGFR-activating mutations. At the OS data cutoff, median OS was 34.1 months with dacomitinib compared to 26.8 months with gefitinib. Patients receiving dacomitinib had a 56.2% survival rate at 30 months compared with 46.3% for patients who received gefitinib. Subgroup analyses were consistent with the primary OS analysis across most baseline characteristics, including patients with common sub-mutations exon 19 and 21. The adverse events, or AEs, observed with dacomitinib in the study were consistent with findings from previous dacomitinib trials. The most common AEs were diarrhea, nail changes, rash/dermatitis acneiform and mouth sores.