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ESMO 2022: ADAURA Update on Adjuvant Osimertinib in Completely Resected EGFR-Mutated NSCLC

By: Julia Fiederlein
Posted: Tuesday, September 27, 2022

In the primary analysis of the phase III ADAURA trial, many patients with completely resected EGFR-mutated non–small cell lung cancer (NSCLC) derived a disease-free survival benefit with the third-generation EGFR tyrosine kinase inhibitor osimertinib versus a placebo. The updated long-term exploratory analysis of disease-free survival and recurrence patterns was presented by Masahiro Tsuboi, MD, PhD, of the National Cancer Center Hospital East, Kashiwa, Japan, and colleagues during the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA47).

“With 2 years [of] further follow-up, a continued disease-free survival benefit was sustained with osimertinib versus the placebo, consistent with the primary analysis,” the investigators commented. “These mature data reinforce adjuvant osimertinib as a standard of care for patients with EGFR-mutated stage IB to IIIA NSCLC after complete tumor resection and adjuvant chemotherapy, when indicated.”

A total of 682 patients with completely resected EGFR-mutated stage IB to IIIA NSCLC and a World Health Organization performance status score of 0 or 1 were randomly assigned in a 1:1 ratio to receive 80 mg of osimertinib once daily or a placebo for up to 3 years. In those with stage II to IIIA disease, the disease-free survival hazard ratio was 0.23; the 3-year disease-free survival rate was higher with osimertinib than with the placebo (84% vs. 34%). The disease-free survival hazard ratio was 0.27 in the overall population; the 3-year disease-free survival rate was 85% with osimertinib and 44% with the placebo.

Compared with those given the placebo, fewer patients treated with osimertinib experienced local or regional and distant recurrence. The central nervous system disease–free survival hazard ratio was 0.24 in patients with stage II to IIIA disease. As for long-term safety, the adverse events were consistent with the known profile of osimertinib.

Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.


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