Positive results from the ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo.
The trial assessed osimertinib as an adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
The results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and have been published in The New England Journal of Medicine.
Tagrisso reduced the risk of death by 51% compared to placebo in both the primary analysis population (Stages II-IIIA) and in the overall trial population (Stages IB-IIIA).
In the primary analysis population, an estimated 85% of patients treated with Tagrisso were alive at five years compared to 73% on placebo. In the overall trial population, an estimated 88% of patients treated with Tagrisso were alive at five years compared to 78% on placebo.
Median OS was not yet reached in either population or treatment group. Patients on placebo that recurred with metastatic disease had the opportunity to receive Tagrisso as a subsequent treatment.
Roy Herbst, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut, US, and principal investigator in the trial, said: “These highly anticipated overall survival results, with 88% of patients alive at five years, are a momentous achievement in the treatment of early-stage EGFR-mutated lung cancer. These data underscore that adjuvant treatment with osimertinib provides patients with the best chance of long-term survival.”