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Benjamin P. Levy, MD, discusses the disease-free survival benefit with adjuvant osimertinib in the phase 3 ADAURA trial.
Benjamin P. Levy, MD, associate professor of oncology and clinical director of Medical Oncology at Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital, discusses the disease-free survival (DFS) benefit achieved with adjuvant osimertinib (Tagrisso) in patients with EGFR-mutant lung cancer.
The most mature data available in targeted therapy for resected lung cancer is with osimertinib, says Levy. The field knows that osimertinib is the standard-of-care option for patients with advanced stage EGFR-mutant lung cancer, as it provides a survival advantage, is better tolerated, and yields a better intracranial response, says Levy. Building on these findings, osimertinib is under exploration in the adjuvant setting.
In the ADAURA trial, investigators enrolled patients who had stage IB to IIIA resected EGFR-mutant lung cancer. Those enrolled were randomized 1:1 to receive either osimertinib or placebo. Patients were allowed to receive chemotherapy at the discretion of their physician, says Levy. Data reported during the 2020 ASCO Virtual Scientific Program, now published in the New England Journal of Medicine, demonstrated a significant improvement in DFS.
Research presented more recently at the 2020 ESMO Virtual Congress showed a decreased relapse rate in the brain. The DFS benefit justifies potentially using this drug despite not yet having an FDA approval, accoring to Levy.
The challenge with this study is that no overall survival data are available; the data are too immature. Another challenge is the cost of the drug. Despite the challenges observed with the study, the DFS benefit was profound enough to encourage the use of osimertinib in this setting, concludes Levy.