Tagrisso
Request personal visitSign up for the AZ E-Information Service
Share

Overview

ADJUVANT TAGRISSO® transforms the treatment options of resectable EGFRm NSCLC1

ESMO NCCN ASCO RECOMMENDED
OSDFS

Significantly improved overall survival1

-51 % reduced risk of death with ADJUVANT TAGRISSO® compared to the control arm in stage IB-IIIA
(HR=0.49 [95% CI: 0.34-0.70; P<0.0001])

DFSDFS

Lower risk of recurrence2

-73 % reduced risk of recurrence or death with ADJUVANT TAGRISSO® compared to the control arm in stage IB-IIIA (HR=0.27 [95% CI: 0.21-0.34])

CNSBrain

Fewer CNS recurrences and distant metastases2

-76 % reduced risk of brain metastases with ADJUVANT TAGRISSO® compared to the control arm in Stage II-IIIA (HR=0.24 [95% CI: 0.14-0.42])

-59 % reduction in the relative risk of distant metastases with ADJUVANT TAGRISSO® compared to the control arm (15% vs. 37%)

Study design

ADAURA: global phase III study in patients with resectable EGFRm NSCLC (IB-IIIA)2

globale Phase-III-Studie bei Patienten mit reseziertem EGFRm NSCLC

Primary endpoint: Disease-free survival (DFS) in patients with NSCLC in stage II and IIIA (according to 7th AJCC edition*)

Secondary endpoints: DFS in the total population (stage IB-IIIA, according to 7th AJCC edition*), DFS after 2, 3, 4 and 5 years, overall survival, safety, health related quality of life.

  • * AJCC 7th edition: Stage IIIA includes stage IIIB patients (T3 N2 M0) according to the 8th edition.
  • † Centrally confirmed in tissue.
  • ‡ According to guidelines, at the discretion of the physician. Prior, subsequent or planned radiation was not permitted. Neoadjuvant chemotherapy was not permitted.
  • # Stratification factors: Stage (IB vs II vs IIIA), EGFRm (Ex19del vs L858R), ethnic ancestry (Asiatic vs non-Asiatic).
  • DFS: Disease-free survival; EGFR: Epidermal growth factor receptor; NSCLC: Non-small cell lung cancer.

Results

  • OS
  • OS in subgroups
  • DFS
  • DFS per stage
  • Recurrences

ADJUVANT TAGRISSO® significantly improves overall survival in stage IB-IIIA1

OS

Data cut-off: January 27, 2023
Data maturity was 18 % at the time of analysis (osimertinib 12%, placebo 24%); Median follow-up for OS: osimertinib 60.4 months, placebo 59.4 months.

Adapted according to Tsuboi M, et al. 20231
OS: Overall survival; HR: Hazard ratio.

Safety

Known safety and tolerability profile of TAGRISSO® in ADAURA2

Reported adverse events of all causes (≥10% of patients)

Berichtete unerwünschte Wirkungen aller Ursachen

Adapted according to Herbst R, et al. 20232

Data cut-off: April 11, 2022

  • Median duration of exposure: TAGRISSO® 35.8 months (range 0 to 38), placebo 25.1 months (range 0 to 39)
  • None of the adverse events that occurred in at least 10% of patients were grade 4 or higher
  • Adverse events that led to a dose reduction: TAGRISSO® n = 42 (12%); control arm n = 3 (1%)
  • Adverse events that led to treatment interruption: TAGRISSO® n = 91 (27%); control arm n = 43 (13%)
  • Adverse events that led to treatment discontinuation: TAGRISSO® n = 43 (13%); control arm n = 9 (3%)
  • Treatment related adverse events that led to death: TAGRISSO® n = 0; control arm n = 0
Treatment with ADJUVANT TAGRISSO® did not lead to a reduction in quality of life7
More information about Risk of recurrence

References:

  1. Tsuboi M, et al., Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023. 389:137–47. doi: 10.1056/NEJMoa2304594.
  2. Herbst R, et al. Adjuvant Osimertinib for resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer: Updated results from the phase III randomized ADAURA trial. J Clin Oncol 2023.
  3. Remon J et al. Early and locally advanced non-small-cell lung cancer: an update of the ESMO Clinical Practice Guidelines focusing on diagnosis, staging, systemic and local therapy, Annals of Oncology 2021; 32(12): 1637-42.
  4. Referenced with the approval of NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V.8.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Access on 24/09/2025. NCCN gives no guarantee of any kind with regard to their content or use and rejects any responsibility for their use in any way.
  5. Pisters K, et al. Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I-IIIA Completely Resected Non–Small-Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update. J Clin Oncol 2022; 40:1127-1130.
  6. Peters S, et al. The impact of brain metastasis on quality of life, resource utilization and survival in patients with non-small-cell lung cancer. Can Treat Rev. 2016;45:139–162.
  7. Majem M, et al. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun 1;28(11):2286-2296.

Professionals can request the mentioned references from AstraZeneca AG.

×