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
WILMINGTON, Del.--(BUSINESS WIRE)--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 (
EGFR
m) non-small cell lung cancer (NSCLC) after complete tumor 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 percent 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 prioritizing
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 percent 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.”
Summary of updated OS results: ADAURA
i,ii
TAGRISSO
Placebo
Stages II-IIIA (primary population)
(n=233)
(n=237)
Median duration of follow-up, in months
92
68.5
OS HR (95% CI)
0.53 (0.38, 0.75)
OS rate at 96 months (95% CI), %
74 (67, 80)
58 (50, 65)
Stage IB-IIIA (overall population)
(n=339)
(n=343)
Median duration of follow-up, in months
93.3
79.6
OS HR (95% CI)
0.52 (0.39, 0.71)
OS rate at 96 months (95% CI), %
79 (74, 83)
64 (58, 70)
i The updated analysis data cut-off (DCO) date was May 4, 2026.
ii This exploratory long-term OS analysis was conducted in all randomized patients. 127 patients did not have additional survival data and remained censored, with survival time unchanged from the planned final OS analysis until May 4, 2026.
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 pro 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)
EGFR
m 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
EGFR
m 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 favored TAGRISSO plus platinum–pemetrexed versus TAGRISSO monotherapy regardless of baseline TP53 co-mutation status.
IMPORTANT SAFETY INFORMATION
There are no contraindications for TAGRISSO
TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy; 0.4% of cases were fatal
ILD/Pneumonitis with TAGRISSO in combination with Pemetrexed and Platinum-based Chemotherapy:
In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal
ILD/Pneumonitis Following Definitive Platinum-based Chemoradiation Therapy (CRT):
In the LAURA study, following definitive platinum-based CRT, ILD/pneumonitis including radiation pneumonitis, occurred in 80 of the 143 patients (56%) who received TAGRISSO monotherapy and 28 of the 73 patients (38%) who received placebo. There was one fatal case (0.7%), 3.5% Grade 3, 34% Grade 2, and 18% Grade 1 adverse reactions of ILD/pneumonitis in TAGRISSO-treated patients. For TAGRISSO-treated patients, ILD/pneumonitis led to permanent discontinuation of TAGRISSO in 7% of patients and dosage interruptions of TAGRISSO in 35% of patients. Among the 46 patients who were rechallenged with TAGRISSO, 11% had recurrence of ILD/pneumonitis. In the 80 TAGRISSO-treated patients, ILD/pneumonitis resolved in 40%, resolved with sequelae in 1.3%, were resolving in 16%, did not resolve in 41%, and resulted in death in 1.3%
For patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed. For patients who have received recent definitive platinum-based CRT with Grade 1 ILD/pneumonitis, continue TAGRISSO or interrupt and restart, as appropriate. Permanently discontinue TAGRISSO in patients diagnosed with Grade ≥2 ILD/pneumonitis
TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Clinical trials of TAGRISSO did not enroll patients with baseline QTc of >470 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. In the LAURA study, following platinum-based CRT, 3% (4/135) of TAGRISSO-treated patients and no placebo-treated patients experienced LVEF decreases ≥10% and a drop to <50%. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum- based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO
Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist
Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed
Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
Aplastic anemia has been reported in TAGRISSO-treated patients in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated
Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose
Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose
Most common (≥20%) adverse reactions, including laboratory abnormalities, were:
TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue
TAGRISSO monotherapy following platinum-based chemoradiation therapy: lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19
TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine
INDICATIONS
TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
Please see complete
Prescribing Information
, including
Patient Information
for TAGRISSO.
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 tumors, the majority eventually develop recurrence despite complete tumor 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
EGFR
m NSCLC.
9-11
These patients are particularly sensitive to treatment with an
EGFR
-tyrosine kinase inhibitor (
EGFR
-TKI) which block the cell-signaling pathways that drive the growth of tumor cells.
12
ADAURA
ADAURA was a randomized, double-blind, placebo-controlled, global Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA
EGFR
m NSCLC following complete tumor resection and, at physicians’ and patients’ discretion, adjuvant chemotherapy. Patients were treated with TAGRISSO
80 mg once-daily oral tablets or placebo for three years or until disease recurrence.
The trial was enrolled in more than 200 centers 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 randomized 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 May 4, 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 May 4, 2026.
TAGRISSO
®
(osimertinib)
TAGRISSO
®
(osimertinib) is a third-generation, irreversible
EGFR
-TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases. TAGRISSO (40 mg and 80 mg 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
EGFR
m 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
EGFR
m NSCLC, locally advanced or metastatic
EGFR
T790M mutation-positive NSCLC, adjuvant treatment of early-stage
EGFR
m 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
EGFR
m NSCLC.
There is an extensive body of evidence supporting the use of TAGRISSO in
EGFR
m 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 savolitinib
in the
SAFFRON
Phase III trial and in combination with datopotamab deruxtecan-dlnk 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 gefitinib; sunvozertinib;
durvalumab and tremelimumab-actl; fam-trastuzumab deruxtecan-nxki and datopotamab deruxtecan-dlnk
in collaboration with Daiichi Sankyo; savolitinib 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 catalyze changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit
astrazeneca-us.com
and follow the Company on social media
@AstraZeneca
.
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Contacts
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