The EGFR tyrosine kinase inhibitor osimertinib may improve rates of disease-free survival and reduce the risk of recurrence in patients with resected, EGFR-mutant non–small cell lung cancer (NSCLC), according to a new exploratory analysis of the ADAURA trial published by Roy S. Herbst, MD, PhD, and colleagues in the Journal of Clinical Oncology.
Roy S. Herbst, MD, PhD
ADAURA Trial Methods and Findings
In the phase III ADAURA clinical trial, researchers assessed the safety and efficacy of osimertinib in 682 patients with completely resected stage IB to IIIA NSCLC, who were previously treated with or without adjuvant chemotherapy. The new data show that there may be ongoing benefits for patients with NSCLC taking osimertinib—including prolonged disease-free survival compared with those taking placebo, reduced risk of local and distant metastases, and improved central nervous system disease-free survival. These findings support the efficacy of adjuvant osimertinib for this patient population.
“These data [represent] a new paradigm demonstrating the importance of using targeted therapy against EGFR-driven tumors as early as possible in the course of a patient’s disease,” commented lead study author Dr. Herbst, who is Ensign Professor of Medicine and Professor of Pharmacology at the Yale School of Medicine; as well as the Deputy Director, Chief of Medical Oncology, and Director of the Center for Thoracic Cancers at Yale Cancer Center. “The results have led to a new standard of care in this disease setting,” he emphasized.
Dr. Herbst and his colleagues randomly assigned the 682 patients who participated in the study to receive either 80 mg of osimertinib once daily or placebo, and found that fewer patients treated with osimertinib experienced recurrence. Data also showed that fewer patients who received osimertinib had distant metastases compared to the placebo group.
Additionally, the researchers found that the 4-year rate of disease-free survival was 73% for the osimertinib group and 38% for the placebo group. Only 27% of the patients who were randomly assigned to receive osimertinib had disease recurrence compared with 60% among those receiving placebo. The data from this study demonstrated prolonged disease-free survival and reduced local and distant recurrence of symptoms—supporting osimertinib as a highly effective treatment in patients with resected EGFR-mutated stage IB to IIIA NSCLC.
“This therapy was well tolerated and prevented patients from developing metastasis to distant sites such as the brain, bones, and other areas of the lungs,” Dr. Herbst concluded, underscoring that “This has truly impacted the lives of our patients.”
Disclosure: The research in this study was supported by AstraZeneca, the manufacturer of osimertinib. For full disclosures of the study authors, visit ascopubs.org.
