Showed a targeted pill after lung cancer surgery halves the risk of death, the first such result for a targeted therapy.
ADAURA, trial NCT02511106 sponsored by AstraZeneca and reported in 2020 with survival results in 2023, showed that three years of osimertinib after resection of stage IB to IIIA EGFR-mutant non-small-cell lung cancer halves the risk of death, the first such result for a targeted therapy. It randomised 682 patients to osimertinib or placebo, met its primary disease-free survival endpoint in stage II to IIIA disease with a very large effect, and showed an overall survival benefit at five years. OnCo links it to non-small-cell lung cancer, EGFR as a target, osimertinib, Roy S. Herbst, Yi-Long Wu, ALINA, the Chinese Thoracic Oncology Group, Guangdong Provincial People's Hospital, the FLAURA and ADAURA papers and terms on data maturity and EGFR mutation subtypes. Whether three years is the right duration is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
682 enrolled.
Median DFS not reached with osimertinib at the primary analysis
SourcePost hoc exploratory update, data cut-off 4 May 2026
SourcePost hoc exploratory update, data cut-off 4 May 2026
SourceStep lines join published landmark estimates; the true curve between them is not shown.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival, stage II to IIIAprimary | Osimertinib | 233 | Median DFS not reached with osimertinib at the primary analysis | 0.17 (0.11 to 0.26) | <0.001 | link |
| Placebo | 237 | 19.6 months | ||||
| Overall survival at 5 years, stage II to IIIA | Osimertinib | - | 85% | 0.49 (0.33 to 0.73) | <0.001 | link |
| Placebo | - | 73% | ||||
| Overall survival at 5 years, stage IB to IIIA | Osimertinib | - | 88% | 0.49 (0.34 to 0.7) | - | link |
| Placebo | - | 78% | ||||
| 8-year overall survival, stage II to IIIA | Osimertinib | - | 74% | 0.53 (0.38 to 0.75) | - | link |
| Placebo | - | 58% | ||||
| 8-year overall survival, stage IB to IIIA | Osimertinib | - | 79% | 0.52 (0.39 to 0.71) | - | link |
| Placebo | - | 64% |
The survival benefit first reported in 2023 has held five years after the last dose of adjuvant osimertinib, which answers the worry that a three-year course only delays relapse. Patients with an exon 19 deletion gained most; the L858R estimate crosses one and is less certain. Nothing here changes the recommendation, which already rests on the 2023 analysis, but it tightens the case for testing every resected non-squamous tumour for EGFR mutations.
Every resected non-squamous lung cancer should be tested for EGFR mutations, because patients who carry one live longer if they take osimertinib for three years after surgery. The trial does not tell us whether adjuvant chemotherapy can be omitted, nor what happens on relapse after osimertinib, and the three-year duration was chosen empirically.
Anyone diagnosed with advanced lung cancer should have EGFR testing before treatment, because osimertinib as the first drug gives the longest disease control, protects the brain, and is well tolerated. Chemotherapy is not the first step for these patients. The remaining questions are whether to intensify upfront (adding chemotherapy or amivantamab) and how to treat resistance when it develops.
Shares Autonomous closed-loop adaptive therapy driven by blood tests and evolutionary models, Guangdong Provincial People's Hospital, Add the second drug on day one when the escape route is predictable, FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer.
Shares Data maturity (immature vs mature survival data), Absolute versus relative benefit (number needed to treat), Interim analysis, readout and data cut-off, Kaplan-Meier curve, censoring and proportional hazards.
Shares Autonomous closed-loop adaptive therapy driven by blood tests and evolutionary models, Add the second drug on day one when the escape route is predictable, FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer, Osimertinib.
Shares Autonomous closed-loop adaptive therapy driven by blood tests and evolutionary models, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall, Osimertinib, EGFR-mutated non-small-cell lung cancer.
Shares Data maturity (immature vs mature survival data), Group sequential design, stopping rules and alpha spending, Interim analysis, readout and data cut-off, Event-free / disease-free survival (EFS, DFS, iDFS, RFS).
Shares Absolute versus relative benefit (number needed to treat), Statistical power, sample size and re-estimation, Kaplan-Meier curve, censoring and proportional hazards, Randomised trial.
Shares Chinese Thoracic Oncology Group, ADAURA: exploratory eight-year overall survival update for adjuvant osimertinib in resected EGFR-mutated stage IB to IIIA lung cancer, ADAURA: three years of osimertinib after surgery for EGFR-mutated lung cancer, EGFR.
Shares Add the second drug on day one when the escape route is predictable, FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall, EGFR-mutated non-small-cell lung cancer.