236P Adjuvant osimertinib in resected EGFR-mutated NSCLC: A real-world analysis from the Italian ATLAS registry

Background:The phase III ARTS trial established adjuvant aumolertinib as a standard treatment for stage IIA-IIIB EGFR-mutated NSCLC.However, robust real-world evidence regarding its long-term efficacy and safety, particularly in earlier-stage (IA2-IIIA) disease, remains limited.This multicenter analysis evaluated the long-term outcomes of adjuvant aumolertinib in a real-world cohort of patients with completely resected stage IA2-IIIA EGFR-mutated NSCLC.Methods: Patients with radically resected EGFR-mutated (exon 19 deletion or L858R) stage IA2-IIIA NSCLC from four Chinese centers were included.All patients received oral aumolertinib 110 mg once daily, with treatment duration individualized (1-3 years) based on pathological stage and clinician judgment.The primary endpoints were disease-free survival (DFS) and safety.Results: A total of 311 patients were enrolled: stage IA (n=172, 55.3%), IB (n=66, 21.2%), II (n=44, 14.1%), and IIIA (n=29, 9.3%).After a median follow-up of 43.1 months (data cutoff as of December 2025), the 5-year DFS rate for the overall population was 85.0%, with the median DFS not yet reached.7 patients deaths were recorded.Notably, among patients with stages IB to IIIA disease, the median DFS was 66.1 months-a finding comparable to the reported efficacy of adjuvant osimertinib in similar stage populations.Of particular interest, 80.1% (249/311) of stage I patients presented with high-risk pathological factors; nevertheless, this subgroup maintained a high 5-year DFS rate of 89.2%.The CNS protective effect was outstanding: only 4 patients experienced CNS recurrence, yielding a 5-year CNS-DFS rate of 98.0%.AEs were documented in 200 patients, with an incidence of 52.5% (105/200).Events were predominantly grade 1-2, most commonly rash (26.0%), elevated liver enzymes (10.5%), diarrhea (7.5%), and oral ulceration (7.0%).Only one patient (0.5%) experienced a grade 3 TRAE.Conclusions: This extended real-world analysis confirms that adjuvant aumolertinib provides sustained efficacy, exceptional CNS protection, and a superior safety profile.These findings support its routine clinical use in patients with resected EGFRmutated NSCLC across stages IA2-IIIA.

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Journal
ESMO Open
Published
2026-03-17
DOI
https://doi.org/10.1016/j.esmoop.2026.106544
Primary Topic
Lung Cancer Treatments and Mutations
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article
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article

236P Adjuvant osimertinib in resected EGFR-mutated NSCLC: A real-world analysis from the Italian ATLAS registry

A.J. Gelibter, Lorenzo Calvetti, C.M. Catania, Lorenzo Belluomini et al.
ESMO Open
Lung Cancer Treatments and Mutations
article

236P Adjuvant osimertinib in resected EGFR-mutated NSCLC: A real-world analysis from the Italian ATLAS registry

A.J. Gelibter, Lorenzo Calvetti, C.M. Catania, Lorenzo Belluomini, Giulia Pasello, Tiziana Vavalà, Elisa Roca, A. Veccia, F. Passiglia, M.L. Reale, U. Malapelle, S. Novello, R. Chiari, A.M. Catino, K. Andrikou, G. Alì, S. Grisanti, M. Tiseo, D. Giannarelli
article en

Abstract

Background:The phase III ARTS trial established adjuvant aumolertinib as a standard treatment for stage IIA-IIIB EGFR-mutated NSCLC.However, robust real-world evidence regarding its long-term efficacy and safety, particularly in earlier-stage (IA2-IIIA) disease, remains limited.This multicenter analysis evaluated the long-term outcomes of adjuvant aumolertinib in a real-world cohort of patients with completely resected stage IA2-IIIA EGFR-mutated NSCLC.Methods: Patients with radically resected EGFR-mutated (exon 19 deletion or L858R) stage IA2-IIIA NSCLC from four Chinese centers were included.All patients received oral aumolertinib 110 mg once daily, with treatment duration individualized (1-3 years) based on pathological stage and clinician judgment.The primary endpoints were disease-free survival (DFS) and safety.Results: A total of 311 patients were enrolled: stage IA (n=172, 55.3%), IB (n=66, 21.2%), II (n=44, 14.1%), and IIIA (n=29, 9.3%).After a median follow-up of 43.1 months (data cutoff as of December 2025), the 5-year DFS rate for the overall population was 85.0%, with the median DFS not yet reached.7 patients deaths were recorded.Notably, among patients with stages IB to IIIA disease, the median DFS was 66.1 months-a finding comparable to the reported efficacy of adjuvant osimertinib in similar stage populations.Of particular interest, 80.1% (249/311) of stage I patients presented with high-risk pathological factors; nevertheless, this subgroup maintained a high 5-year DFS rate of 89.2%.The CNS protective effect was outstanding: only 4 patients experienced CNS recurrence, yielding a 5-year CNS-DFS rate of 98.0%.AEs were documented in 200 patients, with an incidence of 52.5% (105/200).Events were predominantly grade 1-2, most commonly rash (26.0%), elevated liver enzymes (10.5%), diarrhea (7.5%), and oral ulceration (7.0%).Only one patient (0.5%) experienced a grade 3 TRAE.Conclusions: This extended real-world analysis confirms that adjuvant aumolertinib provides sustained efficacy, exceptional CNS protection, and a superior safety profile.These findings support its routine clinical use in patients with resected EGFRmutated NSCLC across stages IA2-IIIA.

ESMO OpenVol. 11
University of Pisa (IT), University of Verona (IT), University of Parma (IT), University of Padua (IT), Policlinico Umberto I (IT), Agostino Gemelli University Polyclinic (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Santa Chiara (IT), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Casa di Cura Villa Garda (IT), Istituto Oncologico Veneto (IT), Azienda Sanitaria Locale di Asti (IT), Federico II University Hospital (IT), Humanitas Gavazzeni (IT), Istituto Tumori Bari (IT), Ospedale San Bortolo (IT), Ospedale Vito Fazzi (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Ospedale San Luigi Gonzaga (IT), Azienda Ospedaliera Universitaria Pisana (IT), University of Turin (IT), University of Naples Federico II (IT), University of Brescia (IT), Sapienza University of Rome (IT)
Openalex Percentile: Top 19%
Lung Cancer Treatments and Mutations
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