Adjuvant osimertinib continues to demonstrate a disease-free survival (DFS) benefit, compared with placebo, in patients with resected, stage IB-IIIA, EGFR-mutated non-small cell lung cancer (NSCLC), according to data presented at ESMO Congress 2022.1
Updated results from the phase 3 ADAURA trial showed that osimertinib was associated with a 73% reduction in the risk of disease recurrence or death among patients with stage IB-IIIA NSCLC and a 77% reduction in the risk of recurrence or death among patients with stage II-IIIA disease.
“These updated data reinforce adjuvant osimertinib as the standard of care for patients with EGFR-mutated, stage IB-IIIA non-small cell lung cancer after complete tumor resection, with or without adjuvant chemotherapy,” said study presenter Masahiro Tsuboi, MD, of the National Cancer Center Hospital East in Kashiwa, Japan.
The phase 3 ADAURA trial (ClinicalTrials.gov Identifier: NCT02511106) included 682 patients with completely resected, EGFR-mutated, stage IB-IIIA NSCLC. The patients were randomly assigned to receive daily osimertinib (n=339) or placebo (n=343), with or without adjuvant chemotherapy.
Baseline characteristics were well balanced between the treatment arms. Patients were treated until disease recurrence, treatment completion at 3 years, or other discontinuation criteria were met.
In the primary analysis, there was a significant improvement in DFS with osimertinib among patients with stage II-IIIA disease (hazard ratio [HR], 0.17; 99.06% CI, 0.11-0.26; P <.001) and in the overall cohort (HR, 0.20; 99.12% CI, 0.14-0.30; P <.001).2
Dr Tsuboi presented results with 2 additional years of follow-up, which allowed all patients the opportunity to receive 3 years of adjuvant treatment.1
Among patients with stage II-IIIA disease, the median DFS was 65.8 months with osimertinib and 21.9 months with placebo (HR, 0.23; 95% CI, 0.18-0.30). At 48 months, the DFS rate was 70% and 29%, respectively.
In the overall cohort, the median DFS was 65.8 months with osimertinib and 28.1 months with placebo (HR, 0.27; 95% CI, 0.21-0.34). At 48 months, the DFS rate was 73% and 38%, respectively. DFS favored osimertinib across all prespecified subgroups.
In the overall cohort, the rate of disease recurrence was lower in the osimertinib arm than in the placebo arm —27% and 60%, respectively. In both arms, the most common first sites of recurrence were the lung, lymph nodes, and central nervous system.
The rate of grade 3 or higher adverse events (AEs) was 23% in the osimertinib arm and 14% in the placebo arm. The rate of discontinuation due to AEs was 13% and 3%, respectively. The most common grade 3-4 AEs in the osimertinib arm were diarrhea and stomatitis.
Disclosures: This study was supported by AstraZeneca. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
1. Tsuboi M, Wu Y, Grohe C, et al. Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC): Updated results from ADAURA. Presented at ESMO 2022; September 9-13, 2022. Abstract LBA47.
2. Wu Y-L, Tsuboi M, He J, et al. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2020;383(18):1711-1723. doi:10.1056/NEJMoa2027071