ASCO 2023: Final Overall Survival Data From ADAURA Trial of Adjuvant Osimertinib in EGFR-Mutated NSCLC

By: Julia Fiederlein Cipriano
Posted: Tuesday, June 6, 2023

Based on previous data from the phase III ADAURA trial, patients with completely resected EGFR-mutated non–small cell lung cancer (NSCLC) derived a disease-free survival benefit from adjuvant treatment with the third-generation EGFR tyrosine kinase inhibitor osimertinib, according to Roy Herbst, MD, PhD, of the Yale Cancer Center, New Haven, Connecticut, and colleagues. The results of the final overall survival analysis, which were presented at a press briefing during the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract LBA3), indicated a significant benefit in this secondary endpoint, regardless of prior adjuvant chemotherapy, for those with stage IB to IIIA disease.

“ADAURA is the first global phase III study to demonstrate a statistically significant disease-free and overall survival benefit with targeted treatment for patients with EGFR-mutated stage IB to IIIA NSCLC,” the investigators remarked. “This further reinforces the need to identify these patients with available biomarkers at the time of diagnosis and before treatment begins,” stated Dr. Herbst in an ASCO news release.

A total of 682 patients with stage IB, II, or IIIA disease and a World Health Organization performance status of 0 or 1 were randomly assigned in a 1:1 ratio to receive 80 mg of osimertinib once daily or a placebo. Prior adjuvant chemotherapy was allowed.

Adjuvant osimertinib was found to significantly improve overall survival versus the placebo. In patients with stage II to IIIA disease, the hazard ratio for overall survival was 0.49 (P = .0004); the 5-year overall survival rates in those with stage II to IIIA disease were 85% and 73% with osimertinib and the placebo, respectively. The hazard ratio for overall survival was 0.49 in the overall population (P < .0001); osimertinib demonstrated a superior 5-year overall survival rate versus the placebo (88% vs. 78%). The median duration of overall survival was not reached in either population or treatment group.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.

2023 ASCO Annual Meeting

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