ADAURA
Osimertinib versus placebo after complete resection of EGFR mutation-positive NSCLC (ADAURA)
Phase 3N = 682NCT02511106
- Population
- Completely resected EGFR mutation-positive stage IB to IIIA NSCLC, with or without previous adjuvant chemotherapy
- Design
- Double-blind phase 3 trial, 1:1 randomisation to osimertinib or placebo for 3 years; primary endpoint investigator-assessed disease-free survival in stage II to IIIA disease; secondary endpoints included DFS in stage IB to IIIA, overall survival and safety
- Primary endpoint
- DFS
- Arms
- Osimertinib (experimental, n = 339): Osimertinib 80 mg once daily for 3 years
- Placebo (control, n = 343): Placebo once daily for 3 years
- People
- Wu YL, ADAURA Investigators
DFSHR 0.17Δ 24-month DFS+46 pointsDFSHR 0.2Δ 24-month DFS+37 pointsOSHR 0.49Δ 60-month OS+12 points
Show the numbers
| Endpoint | Analysis | Osimertinib | Placebo | Effect |
|---|---|---|---|---|
| DFSStage II to IIIA (primary endpoint population)Investigator-assessed; alive and disease-free at 24 months | primaryWu 2020 | 90% at 2 y (84–93%) | 44% at 2 y (37–51%) | HR 0.17P<0.001Hazard ratio for disease recurrence or death 0.17 with a 99.06% confidence interval of 0.11 to 0.26 (as published; not a 95% interval). |
| DFSStage IB to IIIA (overall population) | primaryWu 2020 | 89% at 2 y (85–92%) | 52% at 2 y (46–58%) | HR 0.2P<0.001Hazard ratio for disease recurrence or death 0.20 with a 99.12% confidence interval of 0.14 to 0.30 (as published; not a 95% interval). Secondary endpoint population. |
| OSStage II to IIIA | finalTsuboi 2023 | 85% at 5 y | 73% at 5 y | HR 0.49P<0.001Hazard ratio for death 0.49 with a 95.03% confidence interval of 0.33 to 0.73 (as published; not a 95% interval). Planned final analysis. |
| OSStage IB to IIIA (overall population) | finalTsuboi 2023 | 88% at 5 y | 78% at 5 y | HR 0.49P<0.001Hazard ratio for death 0.49 with a 95.03% confidence interval of 0.34 to 0.70 (as published; not a 95% interval). Planned final analysis. |
| Endpoint | Analysis | Osimertinib | Placebo | Effect |
|---|---|---|---|---|
| DFSStage II to IIIA (primary endpoint population)Investigator-assessed; alive and disease-free at 24 months | primaryWu 2020 | 90% at 2 y (84–93%) | 44% at 2 y (37–51%) | HR 0.17P<0.001Hazard ratio for disease recurrence or death 0.17 with a 99.06% confidence interval of 0.11 to 0.26 (as published; not a 95% interval). |
| DFSStage IB to IIIA (overall population) | primaryWu 2020 | 89% at 2 y (85–92%) | 52% at 2 y (46–58%) | HR 0.2P<0.001Hazard ratio for disease recurrence or death 0.20 with a 99.12% confidence interval of 0.14 to 0.30 (as published; not a 95% interval). Secondary endpoint population. |
| OSStage II to IIIA | finalTsuboi 2023 | 85% at 5 y | 73% at 5 y | HR 0.49P<0.001Hazard ratio for death 0.49 with a 95.03% confidence interval of 0.33 to 0.73 (as published; not a 95% interval). Planned final analysis. |
| OSStage IB to IIIA (overall population) | finalTsuboi 2023 | 88% at 5 y | 78% at 5 y | HR 0.49P<0.001Hazard ratio for death 0.49 with a 95.03% confidence interval of 0.34 to 0.70 (as published; not a 95% interval). Planned final analysis. |
Appears in
Sources
Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, et al. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020;383(18):1711-1723.
Tsuboi M, Herbst RS, John T, Kato T, Majem M, Grohé C, et al. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023;389(2):137-147.