medwireNews: Patients with advanced non-small-cell cancer (NSCLC) with activating EGFR mutations derive a significant overall survival (OS) benefit from first-line treatment with dacomitinib relative to gefitinib, the ARCHER 1050 trial shows.
The findings were reported at the ASCO Annual Meeting 2018 in Chicago, Illinois, USA, and simultaneously published in the Journal of Clinical Oncology.
The authors of an accompanying commentary say that “ARCHER 1050 represents the first randomized, phase III study that directly compared EGFR inhibitors to demonstrate an OS benefit,” and they applaud the researchers “on a well-conducted study that achieved a core benchmark in oncology.”
Last year, the ARCHER 1050 investigators reported that the trial – comprising 452 patients (76.5% Asian) – had met its primary endpoint, showing significantly longer progression-free survival with the second-generation EGFR–tyrosine kinase inhibitor (TKI) dacomitinib than the first-generation agent gefitinib.
And the current analysis, conducted at a median follow-up of 31.3 months, showed that dacomitinib treatment also led to a significant OS improvement, at a median of 34.1 months, compared with 26.8 months for gefitinib (hazard ratio=0.76).
The OS rates at 30 months were 56.2% and 46.3%, respectively, reported presenting author Tony Mok, from the Chinese University of Hong Kong, and dacomitinib was favored in most subgroups, although statistical significance was not always reached due to the limited sample size.
Therefore, he concluded that “dacomitinib should be considered as one of the options as a first-line TKI for patients with an EGFR mutation.”
Commentators Zofia Piotrowska and Justin Gainor, both from Massachusetts General Hospital in Boston, USA, caution that as the trial design excluded patients with brain metastases, which is a common feature of this patient population, this “may limit the generalizability of these results in real-world practice.”
They also highlight that in view of “the evolving landscape of EGFR-mutant NSCLC,” in particular the emerging data on third-generation EGFR–TKIs, such as osimertinib, “the exact positioning of dacomitinib within the treatment armamentarium for EGFR-mutant NSCLC remains to be determined.”
Nonetheless, “the data from ARCHER 1050 illustrate that dacomitinib is a highly potent and active EGFR inhibitor and should remain an option in our clinical toolbox,” conclude Piotrowska and Gainor.
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