Adjuvant osimertinib can improve overall survival (OS) in patients with EGFR-mutated, early-stage non-small-cell lung cancer (NSCLC), according to results from the ADAURA trial presented at the ASCO Annual Meeting 2023.1
“Osimertinib is the first targeted therapy to show significant overall survival benefit in the adjuvant setting,” said study presenter Roy S. Herbst, MD, PhD, of the Yale Cancer Center in New Haven, Connecticut.
“These findings reinforce adjuvant osimertinib as standard of care for patients with resected, EGFR-mutated, stage IB-IIIA non-small-cell lung cancer and highlight the importance of screening and EGFR mutation testing as early as possible to broaden treatment access for patients.”
The ADAURA trial (ClinicalTrials.gov Identifier: NCT02511106) included 682 patients with stage IB-IIIA NSCLC who had undergone surgical resection with or without subsequent adjuvant chemotherapy.
The patients were randomly assigned to receive adjuvant osimertinib at 80 mg once daily (n=339) or placebo (n=343) for up to 3 years. The treatment arms were well balanced for age, sex, race, performance status, disease stage, histology, EGFR mutation status, and receipt of adjuvant chemotherapy.
Prior results from this study showed that osimertinib improved disease-free survival (DFS). The median DFS was 65.8 months with osimertinib and 28.1 months with placebo (hazard ratio [HR], 0.27; 95% CI, 0.21-0.34).
In the current analysis, the median follow-up was 61.5 months. At the data cutoff, 22% of patients in the osimertinib arm and 54% in the placebo arm had received subsequent anticancer treatment, including osimertinib.
In the overall cohort, the 5-year OS rate was 88% in the osimertinib arm and 78% in the placebo arm (HR, 0.49; 95% CI, 0.34-0.70; P <.0001). In patients with stage II/IIIA disease, the 5-year OS rate was 85% in the osimertinib arm and 73% in the placebo arm (HR, 0.49; 95% CI, 0.33-0.73; P =.0004).
Among patients who had received adjuvant chemotherapy, the 5-year OS rate was 87% in the osimertinib arm and 77% in the placebo arm (HR, 0.49; 95% CI, 0.30-0.79). Among patients who had not received adjuvant chemotherapy, the 5-year OS rate was 88% and 79%, respectively (HR, 0.47; 95% CI, 0.25-0.83).
Grade 3 or higher adverse events (AEs) occurred in 23% of patients in the osimertinib arm and 14% in the placebo arm. Grade 3 or higher AEs potentially related to treatment occurred in 11% and 2%, respectively. There were no fatal AEs considered related to treatment.
These results were also published in The New England Journal of Medicine.2
The findings from ADAURA are unprecedented and practice-changing, said ASCO discussant Benjamin Solomon, PhD, MBBS, of the Peter MacCallum Cancer Centre in Melbourne, Australia.
Testing for EGFR mutations in all people diagnosed with early-stage NSCLC should be mandated, and adjuvant osimertinib should be offered to all eligible patients, Dr Solomon said.
Disclosures: This research was supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
1. Herbst RS, Tsuboi M, John T, et al. Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR‑mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). ASCO 2023. June 2-6, 2023. Abstract LBA3.
2. Tsuboi M, Herbst RS, John T, et al. Overall survival with osimertinib in resected EGFR-mutated NSCLC. N Engl J Med. Published online June 4, 2023. doi:10.1056/NEJMoa2304594