Dr Santos on the ADAURA Trial of Adjuvant Osimertinib in EGFR-Mutant NSCLC

Edgardo Santos MD, FACP, FCCP, clinical affiliate associate professor, Charles E. Schmidt College of Medicine, Florida Atlantic University, treasurer, Florida Society of Clinical Oncology, discusses key survival data from the pivotal phase 3 ADAURA trial (NCT02511106) in early-stage non–small cell lung cancer (NSCLC).

The ADAURA trial assessed the efficacy and safety of osimertinib (Tagrisso) in patients with completely resected stage IB to IIIA EGFR-mutant NSCLC who harbor EGFR exon 19 deletions or exon 21 L858R mutations, Santos begins. Although patients were allowed to receive adjuvant chemotherapy before proceeding to osimertinib, it was not required. Patients were randomly assigned 1:1 to receive a once daily 80 mg dose of osimertinib or treatment with placebo. Treatment continued for 3 years, until disease recurrence, or until other discontinuation criteria were met. 

As previously reported, the trial met its primary end point of improved disease-free survival with adjuvant osimertinib, Santos says. This data supported the FDA approval of osimertinib for patients with EGFR-mutant NSCLC following tumor resection in December, 2020. However, overall survival (OS) data were not mature at this time, Santos notes.

Updated findings from the OS analysis of ADAURA were presented at the 2023 ASCO Annual Meeting, and demonstrated that adjuvant osimertinib produced a statistically significant and clinically meaningful OS benefit with osimertinib vs placebo in the primary population, Santos details. Across all patients with stage IB, II, or IIIA NSCLC, osimertinib produced a 51% reduction in the risk of death vs placebo (HR, 0.49; 95.03% CI, 0.34-0.70; P < .0001). The 5-year OS rate in patients with stage II/IIIA disease who were treated with osimertinib was 85% (n = 115) vs 67% in those treated with placebo (n = 119; HR, 0.37; 95% CI, 0.20-0.64). Moreover, the administration of adjuvant osimertinib provided a consistent survival benefit to patients in the overall population regardless of if they had received adjuvant chemotherapy. Santos also notes that adjuvant osimertinib significantly reduced the occurrence of lung cancer brain metastases.

These results solidifies the use of osimertinib as a standard of care in the adjuvant setting for patients with EGFR-mutant disease, Santos says. Accordingly, all patients eligible for surgical resection should be tested for EGFRexon 19 deletions or exon 21 L858R mutations to identify patients who would benefit most from this targeted agent, Santos concludes.