Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.

作者：Jamie E. Chaft, Walter Weder, Jianxing He, Ke‐Neng Chen, Maximilian J. Hochmair, Jin‐Yuan Shih, Sung Yong Lee, Kang-Yun Lee, Nguyễn Thị Hồng Nhung, Somcharoen Saeteng, Carlos Henrique Andrade Teixeira, Carles Escriu, Alex Martínez‐Martí, Collin M. Blakely, Yasushi Yatabe, Sanja Dacic, Xiangning Huang, Yuri Rukazenkov, Anupriya Dayal, Masahiro Tsuboi · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.8001 · 被引用次数：4 · 研究领域：Lung Cancer Treatments and Mutations、Medical Imaging Techniques and Applications、HER2/EGFR in Cancer Research

8001 Background: Based on the Ph 3 ADAURA study, adjuvant (adj) treatment (Tx) with osi, a 3rd-generation, EGFR-TKI, is SoC for resected EGFRm stage (stg) IB–IIIA NSCLC (AJCC 7th ed). Neoadj Tx may improve surgical and long-term outcomes. NeoADAURA (NCT04351555) is a global, Ph 3, randomized, controlled, 3-arm study assessing outcomes with neoadj osi ± CT vs CT alone, in EGFRm R-NSCLC. Methods: Eligible pts: aged ≥18 yrs; WHO PS ≤1; EGFRm (Ex19del/L858R) stg II–IIIB (AJCC 8th ed) R-NSCLC. Pts were stratified (stg II vs III; non-Asian vs Chinese vs other Asian; Ex19del vs L858R) and randomized 1:1:1 to neoadj osi 80 mg QD (≥9 wks) + CT (cis/carboplatin + pemetrexed; 3 cycles, Q3W), osi monotherapy (mono) 80 mg QD (≥9 wks) or placebo (PBO) QD + CT (3 cycles, Q3W). Osi/PBO + CT: double blind; osi mono: open label, sponsor blind. Adj osi was offered to all pts who completed surgery (Sx). Primary endpoint: major pathological response (MPR) by blinded central pathology review. Secondary endpoints included pathological complete response (pCR), event-free survival (EFS), and safety. Data cut-off: Oct 15, 2024. Results: Overall, 358 pts were randomized: osi + CT n=121/osi mono n=117/PBO + CT n=120; baseline characteristics were generally balanced across the respective arms (stg II: 49%/50%/51%; non-Asian: 27%/26%/25%; Ex19del: 50%/51%/51%). After neoadj Tx, 92%/97%/89% of pts underwent Sx in the osi + CT/osi mono/PBO + CT arms. Osi + CT (MPR rate 26%) and osi mono (25%) showed statist...