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.
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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.
References
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
