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In a completely resected Stage IB-IIIA* EGFRm NSCLC (ex19del/L858R), TAGRISSO is the first and only EGFR TKI to deliver a statistically significant DFS and OS benefit vs placebo.1–6
83% relative reduction in risk of recurrence or death vs placebo in the Stage II-IIIA population
ARR 46% at 24 months
HR=0.17 (99.06% CI: 0.11–0.26; P<0.001)7
Primary endpoint
73% relative reduction in risk of recurrence or death vs placebo in the Stage IB-IIIA population (post-hoc analysis)
ARR 35% at 48 months
HR=0.27 (95% CI: 0.21–0.34; P not specified)2
Exploratory endpoint
51% relative reduction in the risk of death vs placebo in the Stage IB-IIIA population (post-hoc analysis)
ARR 10% at 60 months
HR=0.49 (95%CI: 0.34–0.70; P<0.0001)1
Secondary endpoint
*Please note:
2 year DFS: at time of planned interim analysis (data maturity, 33%), pre-specified efficacy boundary was crossed; the trial was unblinded early at recommendation of independent data monitoring committee. The mDFS (median DFS) 2 years stage II-IIIA was NR with TAGRISSO [95% CI 38.8-NC] vs 19.6 months with placebo [95% CI 16.6-24.5]. Due to early unblinding following the interimanalysis, all subsequent analyses, while pre-specified, are considered exploratory and intended to provide additional insight alongside the overall study results.
4-year DFS: Overall population (Stage IB-IIIA): ~45% data maturity; mDFS was 65.8 months (95% CI: 61.7–NC) with TAGRISSO vs 28.1 months with placebo (95% CI: 22.1-35.0).
Primary population (Stage II-IIIA): ~51% data maturity; mDFS was 65.8 months with TAGRISSO (95% CI: 54.4–NC) vs 21.9 months with placebo (95% CI: 16.6-27.5); adjuvant TAGRISSO reduced risk of recurrence or death in stage II-IIIA by 77% vs placebo (HR = 0.23; 95% CI: 0.18-0.30).
5 year OS: data maturity was 18%.1
At the primary analysis, 24-month DFS in the primary endpoint subset was 90% with TAGRISSO vs 44% with placebo (HR=0.17; 99.06% CI: 0.11–0.26; P<0.001).3
Adapted from Tsuboi M et al. ESMO congress 2022.7
Data cut-off: April 2022.
Median DFS: 65.8 months in the TAGRISSO arm (95% CI: 54.4–NC) vs 21.9 months in the placebo arm (95% CI: 16.6–27.5). Data maturity was 51% at the time of analysis.7
ARR, absolute risk reduction; CI, confidence interval; DFS, disease-free survival; EGFRm, epidermal growth factor receptor mutant; HR, hazard ratio; NC, not calculated; NSCLC, non-small cell lung cancer
Adjuvant TAGRISSO helped more patients across Stage IB-IIIA NSCLC (the overall population; TAGRISSO [n=339], placebo [n=343]; primary subset population [Stage II/IIIA]: TAGRISSO [n=233], placebo [n=237]) remain disease-free compared to placebo.2,7
Data cut-off: April 2022.
Median DFS: 65.8 months in the TAGRISSO arm (95% CI: 61.7– NC) vs 28.1 months in the placebo arm (95% CI 22.1– 35.0). Data maturity was 45% at the time of analysis.7
ARR, absolute risk reduction; CI, confidence interval; DFS, disease-free survival; HR, hazard ratio
TAGRISSO is the first and only adjuvant treatment to extend survival in patients with Stage IB-IIIA resected EGFRm NSCLC.1
At 5 years, 88% of patients remained alive in the adjuvant TAGRISSO arm vs 78% in the placebo arm.1
Adapted from Herbst RS et al. ASCO Annual Meeting 2023.1
Data cut-off: January 2023.
*Median follow-up for OS (all patients): osimertinib 60.4 months, placebo 59.4 months. Data maturity was 18% at the time of analysis.1
ARR, absolute risk reduction; HR, hazard ratio: OS, overall survival
Patients with Stage II/IIIA disease also received consistent OS benefit with TAGRISSO.1 TAGRISSO achieved a statistically significant and clinically meaningful OS benefit in the adjuvant setting.1
Adapted from Herbst RS et al. ASCO Annual Meeting 2023.1
Data cut-off: January 2023.
*Median follow-up for OS (all patients): osimertinib 59.9 months, placebo 56.2 months. Data maturity was 21% at the time of analysis.1
ARR, absolute risk reduction; HR, hazard ratio: OS, overall survival
TAGRISSO helped patients reduce their risk of CNS progression.2 According to an exploratory analysis of CNS DFS, 76% relative risk reduction in CNS progression (HR=0.24; 95% CI: 0.14–0.42), P-value not specified.2
TAGRISSO Median CNS DFS
(95% CI: 65.8–NC)
PLACEBO Median CNS DFS
(95% CI: NC–NC)
Adapted from Tsuboi M et al. ESMO congress 2022.7
Data cut-off: April 2022.
Median follow-up: TAGRISSO 44.2 month, placebo 20.4 months. Data maturity: 13% (TAGRISSO 9%, placebo 17%).7 This was a prespecified exploratory endpoint.2
*CNS DFS is defined as CNS as the first site of disease recurrence, or death without any disease recurrence
ARR, absolute risk reduction; CNS, central nervous system; DFS, disease-free survival; HR, hazard ratio; NC, not calculated; NR, not reached
ADAURA was a global, Phase III, 1:1 randomised study of TAGRISSO vs placebo (N=682).3,5,6
Adapted from Wu YL et al. N Engl J Med 2020 and TAGRISSO (osimertinib) Summary of Product Characteristics.3,5,6
*American Joint Committee on Cancer 7th edition.
†Centrally confirmed in tissue. Only actionable EGFR mutations such as ex19del and L858R were included in ADAURA.3,5,6 Patients with exon 20 deletions were not included.3
‡Per physician discretion. Prior, post, or planned radiotherapy was not allowed.3 Neoadjuvant chemotherapy was not allowed.8
EGFR, epidermal growth factor receptor; ex19del, exon 19 deletion; L858R, exon 21 substitution; NSCLC, non-small cell lung cancer; T790M, exon 20 threonine 790 methionine substitution
Navigate the safety profile: ADAURA trial
Take a closer look at how TAGRISSO is administered: ADAURA trial
Learn more about how TAGRISSO works
AJCC, American Joint Committee on Cancer; ARR, absolute risk reduction; CI, confidence interval; CNS, central nervous system; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutant; ex19del, exon 19 deletion; HR, hazard ratio; HRQoL, health-related quality of life; L858R, exon 21 substitution; MOA, mode of action; NC, not calculated; NR, not reached; NSCLC, non-small cell lung cancer; OS, overall survival; TKI, tyrosine kinase inhibitor; T790M, exon 20 threonine 790 methionine substitution; WHO, World Health Organization
GB-63981 | DOP: July 2025
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