A publication in the Journal of Clinical Oncology presented updated trial results regarding disease-free survival (DFS) data from the phase III ADAURA clinical trial, which evaluated the safety and efficacy of osimertinib in patients with surgically removed (completely resected) stage IB-IIA NSCLC and who were previously treated with or without adjuvant chemotherapy. In this publication, researchers at the Yale Cancer Center reported an updated exploratory analysis of final DFS data.
The trial enrolled 682 patients with stage IB-IIIA epidermal growth factor receptor (EGFR)–mutated (exon 19 deletion/L858R) NSCLC who were randomly assigned 1:1 (stratified by stage, mutational status, and race) to receive osimertinib 80 mg once daily or placebo for 3 years.
The primary endpoint was DFS by researcher evaluation in stage II-IIIA disease evaluated by stratified log-rank test; following early reporting of statistical significance in DFS, no further formal statistical testing was scheduled. Secondary endpoints included DFS in stage IB-IIIA, overall survival (OS), and safety. Prespecified exploratory endpoints included patterns of recurrence and central nervous system (CNS) DFS.
The researchers discovered that recurrence happened less in patients treated with osimertinib. Data also demonstrated that fewer patients in the osimertinib group had distant metastases compared with the placebo group. The results revealed that over 4 years, DFS was 73% for the osimertinib group and 38% for the placebo group. They also indicated that fewer patients who were randomly assigned osimertinib had disease recurrence (27%) when compared with those in the placebo group (60%), and the long-term safety profile of osimertinib was consistent with those documented in the primary analysis.
The authors concluded that the efficacy of adjuvant osimertinib as a highly effective therapy in resected EGFR-mutated NSCLC was supported by the updated data, which demonstrated prolonged DFS benefit over placebo, diminished risk of local and distant recurrence, enhanced CNS DFS, and a consistent safety profile.
Roy S. Herbst, lead author and principal researcher of the trial, Ensign Professor of Medicine (medical oncology), and professor of pharmacology and deputy director at Yale Cancer Center, stated, “These data demonstrate a new paradigm demonstrating the importance of using targeted therapy against epidermal growth-factor-driven tumors as early as possible in the course of a patient’s disease. The results have led to a new standard of care in this disease setting.”
Dr. Herbst also stated, “This therapy was well tolerated and prevented patients from developing metastasis to distant sites such as the brain, bone, and other areas of the lung. This has truly impacted the lives of our patients.”
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
« Click here to return to Lung Cancer Awareness.