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.
Authors
- A.J. Gelibter
- Lorenzo Calvetti (ORCID: https://orcid.org/0000-0002-9135-8715)
- C.M. Catania
- Lorenzo Belluomini (ORCID: https://orcid.org/0000-0003-1981-5499)
- Giulia Pasello (ORCID: https://orcid.org/0000-0002-8741-6038)
- 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
Institutions
- 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)
Publication Details
- Journal
- ESMO Open
- Published
- 2026-03-17
- DOI
- https://doi.org/10.1016/j.esmoop.2026.106544
- Primary Topic
- Lung Cancer Treatments and Mutations
- Type
- article
- Field-Weighted Citation Impact
- 0.00