Tagrisso demonstrated unprecedented eight-year landmark survival in
early-stage EGFR-mutated lung cancer in ADAURA Phase III trial

Longest survival data ever reported in a global Phase III trial in this setting
New data reinforce Tagrisso as the standard of care and backbone

therapy in EGFRm lung cancer across stages

Updated exploratory results from the ADAURA Phase III trial showed AstraZeneca’s Tagrisso
(osimertinib) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at
eight years compared to placebo in the adjuvant treatment of patients with early-stage (IB, II
and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer
(NSCLC) after complete tumour resection with curative intent.

These results were presented today during the Presidential Symposium at the IASLC 2026
World Conference on Lung Cancer (#WCLC26) hosted by the International Association for the
Study of Lung Cancer in Seoul, Republic of Korea (Abstract PL03.01). These data were also
simultaneously published in the Journal of Thoracic Oncology.

At eight years of follow-up, results showed that Tagrisso continued to show an OS benefit,

reducing the risk of death compared to placebo by 47% in the primary population (Stages II-
IIIA) (based on a hazard ratio [HR] of 0.53; 95% confidence interval [CI] 0.38-0.75). In the

overall trial population (Stages IB-IIIA), Tagrisso reduced the risk of death compared to
placebo by 48% (HR 0.52; 95% CI 0.39-0.71). An estimated 74% of patients treated with
Tagrisso were alive at eight years versus 58% of those treated with placebo in the primary
population. In the overall trial population, an estimated 79% of patients treated with Tagrisso
were alive at eight years versus 64% of those treated with placebo. Consistent with the
planned final analysis, OS benefit with Tagrisso versus placebo was observed across all
predefined subgroups.
Roy S. Herbst, MD, PhD, Director at Dartmouth Cancer Center, and principal investigator in
the ADAURA Phase III trial, said: “These ADAURA findings show patients continue to
experience meaningful, long-term benefit following early intervention with adjuvant
osimertinib, with a 16 per cent point improvement in overall survival at eight years versus
placebo. This is especially impressive given high rates of crossover to osimertinib following
disease recurrence. This durable overall survival benefit reinforces the importance of
prioritising EGFR testing at diagnosis so as many patients as possible can benefit from this
transformative therapy.”
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said:
“ADAURA continues to set new benchmarks in early-stage EGFR-mutated lung cancer, with
nearly 80 per cent of patients treated with adjuvant Tagrisso alive at eight years. These results

underscore the importance of treating early and reinforce Tagrisso as the adjuvant standard
of care and backbone therapy across stages of the disease.”

Final safety data for ADAURA were collected at the planned final OS analysis, at which time
the safety and tolerability of Tagrisso were consistent with its established profile with no new
safety concerns.
Complementing the ADAURA clinical trial findings, real-world evidence presented at WCLC26
from a retrospective cohort study of US patients with early-stage (I-IIIA) EGFRm NSCLC
(Abstract P1.142) showed that early discontinuation of Tagrisso before completion of the
three-year treatment course more than doubled the risk of disease recurrence or death. These
results reinforce the importance of maintaining the full treatment duration established in
ADAURA and underscore the need for clinician-patient communication to support treatment
persistence.
In the advanced disease setting, additional data presented at WCLC26 from the FLAURA2
Phase III trial reinforced the benefits of backbone therapy Tagrisso in combination with
platinum-pemetrexed chemotherapy in patients with 1st-line advanced EGFRm NSCLC.

Results from a novel safety analysis (Abstract PT2.03.03) showed that with long-term follow-
up (median 42.6 months), the safety and tolerability of Tagrisso plus platinum–pemetrexed

remained consistent with the established safety profiles of these medicines, with clear
reductions in new adverse event onset following the initial induction period. Additionally, an
exploratory analysis (Abstract P2.237) showed that progression-free survival and OS HRs
numerically favoured Tagrisso plus platinum–pemetrexed versus Tagrisso monotherapy
regardless of baseline TP53 co-mutation status.

Notes
NSCLC

Lung cancer is the leading cause of cancer death globally, accounting for almost one in five
(19%) cancer deaths.

1-2 Lung cancer is broadly split into NSCLC and small cell lung cancer,

with 80-85% of patients diagnosed with NSCLC.

3 Approximately 75% of NSCLC patients are
diagnosed with advanced disease while approximately 25-30% present with resectable

disease at diagnosis.4-5 Early-stage lung cancer diagnoses are often only made when the
cancer is found on imaging for an unrelated condition.6
For patients with resectable tumours, the majority eventually develop recurrence despite
complete tumour resection and adjuvant chemotherapy.7 Further, 73% of patients with Stage
IB and 56-65% of patients with Stage II disease will survive for five years. This decreases to
41% for patients with Stage IIIA.8
Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in
Asia have EGFRm NSCLC.9-11 These patients are particularly sensitive to treatment with an
EGFR-tyrosine kinase inhibitor (EGFR-TKI) which block the cell-signalling pathways that drive
the growth of tumour cells.12

ADAURA

ADAURA was a randomised, double-blind, placebo-controlled, global Phase III trial in the
adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete
tumour resection and, at physicians’ and patients’ discretion, adjuvant chemotherapy. Patients
were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until
disease recurrence.
The trial was enrolled in more than 200 centres across more than 20 countries, including the

US, Europe, South America, Asia and the Middle East. The primary endpoint was disease-
free survival (DFS) in Stage II and IIIA patients and key secondary endpoints included DFS in

Stage IB, II and IIIA patients, and OS in both the primary and overall populations.
The exploratory analysis presented at WCLC26 was conducted in all randomised patients
including complete or partial extended long-term survival data from approximately 77% of
those patients who were still alive at the final planned OS analysis DCO. This included trial
participants with additional survival data up until the 4 May 2026 DCO or from accessible
medical records/information from last contact date. 127 patients did not have additional
survival data and remained censored, with survival time unchanged from the planned final OS
analysis until 4 May 2026.
Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity
in NSCLC, including the treatment of central nervous system metastases. Tagrisso (40mg and
80mg QD oral tablets) has been used to treat more than one million patients across its
indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for
patients across multiple stages of EGFRm NSCLC.
Tagrisso is approved as monotherapy in more than 120 countries including the US, EU, China
and Japan. Approved indications include for 1st-line treatment of patients with locally
advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M
mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally
advanced, unresectable NSCLC following platinum-based chemoradiation therapy. Tagrisso
is also approved in combination with chemotherapy in more than 80 countries, including the

US, EU, China and Japan, for 1st-line treatment of patients with locally advanced or metastatic
EGFRm NSCLC.
There is an extensive body of evidence supporting the use of Tagrisso in EGFRm NSCLC,
and it is the only targeted therapy shown to improve patient outcomes across all stages of the
disease.
In late-stage disease, Tagrisso demonstrated improved outcomes as monotherapy in the
FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III
trial. Tagrisso is also being investigated in this setting in combination with Orpathys
(savolitinib) in the SAFFRON Phase III trial and in combination with Datroway (datopotamab
deruxtecan) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.
In addition to ADAURA, Tagrisso also showed improved outcomes in early-stage disease in
the NeoADAURA Phase III trial and in locally advanced stages in the LAURA Phase III trial.
As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung
cancer, Tagrisso is also being investigated in the early-stage adjuvant resectable setting in
the ADAURA2 Phase III trial.

AstraZeneca in lung cancer

AstraZeneca is working to bring patients with lung cancer closer to cure through the detection
and treatment of early-stage disease, while also pushing the boundaries of science to improve
outcomes in the resistant and advanced settings. By defining new therapeutic targets and
investigating innovative approaches, the Company aims to match medicines to the patients
who can benefit most.
The Company’s comprehensive portfolio includes leading lung cancer medicines and the next
wave of innovations, including Tagrisso and Iressa (gefitinib); Zegfrovy (sunvozertinib); Imfinzi
(durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and Datroway
in collaboration with Daiichi Sankyo; Orpathys in collaboration with HUTCHMED; as well as a
pipeline of potential new medicines and combinations across diverse mechanisms of action.
AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working
to accelerate innovation and deliver meaningful improvements for people with lung cancer,
including and beyond treatment.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer
in every form, following the science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company’s focus is on some of the most challenging cancers. It is through persistent
innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the
industry, with the potential to catalyse changes in the practice of medicine and transform the
patient experience.