NSCLC： Archer 1050臨床試驗結果
翻譯 ： Helen Law / 癌症資訊網
By The ASCO Post
Posted: 6/7/2018 10:31:45 AM
Last Updated: 6/7/2018 10:54:22 AM
Overall survival (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 (NSCLC) with EGFR-activating mutations compared to gefitinib showed a median OS of 34.1 months for patients receiving dacomitinib (95% confidence interval [CI] = 29.5–37.7), representing a more than 7-month improvement compared to 26.8 months with gefitinib (95% CI = 23.7–32.1). The OS data from ARCHER 1050 were presented by Mok et al at the 2018 ASCO Annual Meeting (Abstract 9004).
“Overall survival is an important measure to assess efficacy of investigational compounds. These data presented today 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,” said Tony Mok, BMSc, MD, FRCP(C), FRCP(Edin), FHKCP, FHKAM(Medicine), FASCO, Chair of the Department of Clinical Oncology, The Chinese University of Hong Kong. “I look forward to having dacomitinib as a potential first-line treatment option for non–small cell lung cancer patients with EGFR-activating mutations.”
More on ARCHER 1050
Overall survival was a secondary endpoint of ARCHER 1050, a randomized, open-label phase III study comparing the efficacy and safety of dacomitinib to gefitinib for the first-line treatment of locally advanced or metastatic NSCLC in patients with EGFR-activating mutations. At the OS data cutoff, median OS was 34.1 months with dacomitinib (95% CI = 29.5–37.7) compared to 26.8 months with gefitinib (95% CI = 23.7–32.1). 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 submutations exon 19 and 21.
The adverse events observed with dacomitinib in the study were consistent with findings from previous dacomitinib trials. The most common adverse events were diarrhea (87%), nail changes (62%), rash/dermatitis acneiform (49%), and mouth sores (44%). The most common Grade 3 adverse events with dacomitinib were rash (14%) and diarrhea (8%). Grade 4 adverse events occurred in 2% of dacomitinib-treated patients. There was one case of grade 5 diarrhea and one case of grade 5 liver disease. The discontinuation rate due to treatment-related adverse events for dacomitinib was 10% compared to 7% for gefitinib.
“What is most encouraging about these results is that patients with non–small cell lung cancer harboring EGFR-activating mutations who received dacomitinib achieved a median overall survival of nearly 3 years, a marked improvement compared to an established treatment in this setting,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.
In April 2018, the U.S. Food and Drug Administration (FDA) granted priority review for dacomitinib for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR-activating mutations. The FDA Prescription Drug User Fee Act (PDUFA) target action date is in September 2018. The European Medicines Agency also accepted the Marketing Authorization Application for dacomitinib for the same indication.