Perioperative Durvalumab for Resectable NSCLC: Updated Outcomes for Japanese Patients in AEGEAN
In brief
Complete tumor response reached 33% with durvalumab versus 6% in Japanese patients
In this exploratory analysis of 64 Japanese patients with resectable lung cancer, adding durvalumab before and after surgery was linked to a higher complete tumor response rate than chemotherapy alone: 33% versus 6%. Event-free and disease-free survival also favored durvalumab, but estimates were imprecise and overall survival did not differ; larger follow-up is needed to clarify long-term benefit.
- Journal
- Cancer science (Q1)
- Published
- 27 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Tetsuya Mitsudomi, John V Heymach, Yoshitsugu Horio, Fumihiro Tanaka, Hiroshi Tanaka, Shoichi Kuyama, et al.
- PMID
- 42802029
- DOI
- 10.1111/cas.70541
Why clinicians should know about it
- Picked for Surgical Oncology (paper of the day, 28 September 2026): Phase III RCT, perioperative durvalumab improves EFS
- Picked for Oncology and Radiation Oncology (paper of the day, 28 September 2026): Phase III RCT, perioperative durvalumab
Abstract
In the phase 3 AEGEAN study, perioperative durvalumab plus neoadjuvant chemotherapy significantly improved the primary endpoints of event-free survival (EFS) and pathological complete response (pCR) in patients with resectable NSCLC versus neoadjuvant chemotherapy alone. We report prespecified exploratory Japanese subgroup analyses of EFS, disease-free survival (DFS), and overall survival (OS) (interim analyses; data cut-off [DCO] May 10, 2024); pCR (final analysis; DCO November 10, 2022); and safety. In this double-blind, placebo-controlled study, 79 treatment-naïve Japanese patients (stage II-IIIB[N2]) were randomized (1:1) to neoadjuvant chemotherapy plus durvalumab/placebo (every 3 weeks [Q3W], 4 cycles) pre-surgery, then adjuvant durvalumab/placebo (Q4W, 12 cycles). Efficacy was analyzed in the modified intention-to-treat population (N = 64; durvalumab arm n = 30, placebo arm n = 34), which excluded patients with documented EGFR/ALK aberrations. At the corresponding data cutoffs, EFS benefit favored the durvalumab arm (unstratified HR, 0.63; 95% CI, 0.26-1.45; median follow-up, 42 months [censored patients]), and the pCR rate was numerically higher with durvalumab versus placebo (33.3% vs. 5.9%). A clinically meaningful DFS improvement favored the durvalumab arm (unstratified HR 0.47, 95% CI 0.16-1.21); however, no difference in OS was observed (unstratified HR 1.01, 95% CI 0.40-2.51). Grade 3/4 adverse events occurred in 62.2% and 65.9% of patients with durvalumab and placebo, respectively. Improvements in EFS and pCR with perioperative durvalumab plus neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone were comparable to, or greater than, those observed in the global study population, supporting this regimen as a treatment option for Japanese patients. Trial Registration: ClinicalTrials.Gov Identifier NCT03800134.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.