Perioperative treatment and biomarker analysis of LP002 , an anti‐PD‐L1 antibody, plus chemotherapy in resectable gastric and gastroesophageal junction cancer

作者：Jia‐lin Tang, Bo Zhang, Jianping Xu, Ling Qi, Dao Xin, Lin Wang, Bingzhi Wang, Yantao Tian, Yong Li, Jing Huang · 发表于：Cancer Medicine · 年份：2022 · DOI：10.1002/cam4.5414 · 被引用次数：4 · 研究领域：Macrophage Migration Inhibitory Factor、GDF15 and Related Biomarkers、Cancer Immunotherapy and Biomarkers

BACKGROUND: The addition of immune checkpoint inhibitors to perioperative chemotherapy in operable gastric or gastroesophageal junction (GEJ) cancer has become one of the research hotspots, while reliable biomarkers for efficacy are lacking. We conducted a phase 1 trial to assess the safety and efficacy of LP002, an anti-PD-L1 antibody, plus chemotherapy as perioperative treatment in patients with gastric or GEJ cancer. METHODS: We enrolled patients with resectable and PD-L1 positive gastric or GEJ cancers. Eligible patients received three preoperative and six postoperative cycles of intravenous LP002 with cisplatin and 5-fluorouracil, repeated every 2 weeks. The primary endpoint was safety. Secondary endpoints included rate of margin-free (R0) resection and pathological complete response (pCR). We also characterized changes in the tumor immune microenvironment using multiplex immunofluorescence (MIF) staining and next-generation sequencing (NGS) with pre- and post-treatment tumor samples. RESULTS: Thirty patients were enrolled, of whom 28 had GEJ cancer. With a median follow-up of 7.9 months, all patients completed preoperative treatment, and 27 patients underwent surgery. Twenty-four patients underwent R0 resection. Six patients (20.0%) had Mandard tumor regression grade (TRG) 1-3, including one achieving pCR. Twenty-seven patients had treatment-related adverse events (TRAEs), while grade 3-4 TRAEs were observed in 11 patients. No treatment-related deaths occurred. MIF stai...