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Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104)
The clinical efficacy of neoadjuvant immunotherapy plus chemotherapy remains elusive in localized epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). Here, we report interim results of a Simon's two-stage design, phase 2 trial using neoadjuvant sintilimab with carboplatin and nab-paclitaxel in resectable EGFR-mutant NSCLC. All 18 patients undergo radical surgery, with one patient experiencing surgery delay. Fourteen patients exhibit confirmed radiological response, with 44% achieving major pathological response (MPR) and no pathological complete response (pCR). Similar genomic alterations are observed before and after treatment without influencing the efficacy of subsequent EGFR-tyrosine kinase inhibitors (TKIs) in vitro. Infiltration and T cell receptor (TCR) clonal expansion of CCR8+ regulatory T (Treg)hi/CXCL13+ exhausted T (Tex)lo cells define a subtype of EGFR-mutant NSCLC highly resistant to immunotherapy, with the phenotype potentially serving as a promising signature to predict immunotherapy efficacy. Informed circulating tumor DNA (ctDNA) detection in EGFR-mutant NSCLC could help identify patients nonresponsive to neoadjuvant immunochemotherapy. These findings provide supportive data for the utilization of neoadjuvant immunochemotherapy and insight into immune resistance in EGFR-mutant NSCLC.
1.更新的EGFR突变人群免疫化疗新辅助MPR(34.1%)/pCR(11.4%)以及中位EFS数据(25.3m)，L858R相比19del具有相对更好response rate和survival；
2.不同新辅助治疗多队列genomic数据提示RB1或RBM10共突变更可能从免疫联合化疗模式中获益；
3.EGFR突变新辅助免疫化疗后主要以远处复发进展为主，且免疫化疗不影响复发后靶向治疗疗效及安全性，新辅化免序贯辅助Osi不会带来显著安全性问题，肝损较ADAURA队列增高但无显著性。
文献来源：
Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104)
Zhang C, Sun YX, Yi DC, Jiang BY, Yan LX, Liu ZD, Peng LS, Zhang WJ, Sun H, Chen ZY, Wang DH, Peng D, Chen SA, Li SQ, Zhang Z, Tan XY, Yang J, Zhao ZY, Zhang WT, Su J, Li YS, Liao RQ, Dong S, Xu CR, Zhou Q, Yang XN, Wu YL, Zhang ZM, Zhong WZ. Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104). Cell Rep Med. 2024 Jul 16;5(7):101615. doi: 10.1016/j.xcrm.2024.101615. Epub 2024 Jun 18. PMID: 38897205; PMCID: PMC11293361.
Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104): Cell Reports Medicine
Study Details | Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC | ClinicalTrials.gov
Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104) - PubMed (nih.gov)
Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104) - ScienceDirect
Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104) (cell.com)
176.… | The American Association for Thoracic Surgery | AATS
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