WCLC 2025 - Posters & ePosters-PT1.08.01 Neoadjuvant Almonertinib Followed by Chemo-Immunotherapy in II-IIIB EGFR-TKI, Interim Analysis of a Single Arm, Phase II Study (NEOVADE)

PT1.08.01 Neoadjuvant Almonertinib Followed by Chemo-Immunotherapy in II-IIIB EGFR-TKI, Interim Analysis of a Single Arm, Phase II Study (NEOVADE)

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The NEOVADE trial is a single-arm, phase II study investigating neoadjuvant almonertinib followed by chemo-immunotherapy in treatment-naive, resectable stage II-IIIB non-small cell lung cancer (NSCLC) patients harboring EGFR mutations. The regimen consisted of 6 weeks of daily almonertinib (110 mg), followed by three 3-week cycles of adebrelimab (PD-1 inhibitor), nab-paclitaxel, and carboplatin. Primary endpoint was major pathological response (MPR), with secondary endpoints including complete pathological response (pCR), objective response rates (ORR) after each therapy, event-free survival (EFS), overall survival (OS), and safety.<br /><br />As of April 30, 2025, 17 patients completed neoadjuvant therapy and were included in the interim analysis. The cohort had median age 58 years, mostly female (82.4%), ECOG 0-1, and predominantly nonsquamous histology. EGFR mutation subtypes were mainly exon 19 deletions (52.9%) and L858R mutations (41.2%). PD-L1 expression varied, with 47.1% of tumors having ≥1% expression.<br /><br />Results showed an MPR rate of 35.3% and pCR rate of 17.6%. Objective response rate after almonertinib alone was 47.1%, increasing to 68.8% after subsequent chemo-immunotherapy. Disease control rate was 100% at both points. However, toxicity was notable, including one patient discontinuing therapy due to grade 2 hypothyroidism. Response rate differed between EGFR mutation types, with better outcomes in patients exhibiting higher PD-L1 expression.<br /><br />In conclusion, neoadjuvant almonertinib followed by chemo-immunotherapy demonstrated promising pathological responses in EGFR-mutant stage II-IIIB NSCLC, achieving higher MPR rates compared to prior EGFR-TKI or chemo-immunotherapy alone. Nevertheless, toxicity was considerable, warranting cautious evaluation. The data suggest differential efficacy based on EGFR mutation and PD-L1 status, highlighting the need for further studies to optimize patient selection and treatment sequencing in this population.

Asset Subtitle

Jun-tao Lin

Meta Tag

Speaker Jun-tao Lin

Topic Local-Regional Non-small Cell Lung Cancer

Keywords

NEOVADE trial

neoadjuvant almonertinib

chemo-immunotherapy

EGFR-mutant NSCLC

stage II-IIIB non-small cell lung cancer

major pathological response (MPR)

complete pathological response (pCR)

PD-1 inhibitor adebrelimab

EGFR mutation subtypes

treatment toxicity