Tagrisso maintains benefit at 8 years in early lung cancer

Eight-year OS reaches 74% in EGFR-mutant early lung cancer…58% with placebo

Survival gap persists across disease stages…subsequent treatment strategies draw attention

Tagrisso, used as adjuvant therapy after surgery for EGFR-mutant early-stage non-small cell lung cancer (NSCLC), maintained its overall survival (OS) benefit in the long-term follow-up.

The gap between the survival curves persisted even after patients completed 3 years of adjuvant therapy. The findings show that Tagrisso not only reduces the risk of recurrence following complete resection but also provides a sustained long-term survival benefit.

Exploratory 8-year OS follow-up results from the Phase III ADAURA trial evaluating the long-term survival benefit of Tagrisso (osimertinib) in EGFR-mutant early-stage NSCLC were presented at the World Conference on Lung Cancer (WCLC 2026), held at COEX in Seoul on the 14th. The results were presented by Roy S. Herbst, professor at Dartmouth Cancer Center in the US.

Eight-Year OS 74%…survival gap persists after treatment ends

ADAURA is a Phase III trial evaluating adjuvant Tagrisso following surgery in 682 patients with stage IB–IIIA NSCLC harboring an EGFR exon 19 deletion or exon 21 L858R mutation.

Following adjuvant chemotherapy when indicated, patients received Tagrisso 80 mg or placebo for up to 3 years.

At the 8-year follow-up, OS among patients with stage IB–IIIA disease was 74% in the Tagrisso arm versus 58% in the placebo arm. The risk of death was 48% lower with Tagrisso (HR 0.52), with the survival curves remaining separated over long-term follow-up.

Herbst emphasized that the survival benefit persisted even after the 3-year treatment period had ended.

Earlier analyses of ADAURA showed that Tagrisso substantially reduced the risk of recurrence or death and improved disease-free survival (DFS), while subsequent OS analyses also demonstrated a survival benefit. Previous updates showed that the DFS benefit was consistent across major subgroups, including disease stage and use of adjuvant chemotherapy.

Herbst said, “This long-term follow-up shows that the benefit of 3 years of postoperative Tagrisso may persist even after treatment has ended.”

Beyond preventing recurrence to long-term survival

Roy S. Herbst, professor at Dartmouth Cancer Center in the US.

The significance of the findings extends beyond the difference in survival rates at the eight-year mark.

The goal of adjuvant therapy in early-stage lung cancer is to eliminate microscopic residual disease that may remain after surgery and thereby reduce the risk of recurrence.

Even after complete surgical resection, patients with EGFR-mutant lung cancer remain at risk of distant metastasis and central nervous system (CNS) recurrence.

ADAURA has already demonstrated that Tagrisso substantially reduces these recurrence risks. The latest long-term follow-up shows that the earlier improvement in DFS is translating into a sustained OS difference over time.

Given that treatment was administered for a maximum of 3 years, the persistence of the survival gap during the subsequent period without adjuvant Tagrisso is particularly notable.

Herbst likewise framed the significance of the update around “the long-term question of how long the treatment benefit persists after therapy ends.” Ahead of WCLC, expert previews had also identified the durability of osimertinib’s benefit years after treatment completion as a key question for the ADAURA update, given that the drug is already established as a standard of care.

Next challenges: MRD and optimizing treatment duration

With the long-term survival benefit established, the next challenge is to move beyond a uniform 3-year treatment duration for all patients and refine treatment intensity and duration according to individual risk.

Even among patients with the same disease stage and EGFR mutation, the actual risk of recurrence can vary.

Assessment of minimal residual disease (MRD) using circulating tumor DNA (ctDNA) has therefore emerged as a potential tool for tailoring treatment strategies to individual patients.

If patients with residual disease after surgery or those who remain at high risk of recurrence at the end of treatment can be identified, clinicians could consider extending adjuvant therapy, while potentially reducing the treatment burden for lower-risk patients.

Herbst said, “Future research needs to determine which patients derive the greatest benefit from prolonged adjuvant therapy and whether the current 3-year treatment duration is appropriate for every patient.”