A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

This is a phase II, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of GEN-001 in combination with avelumab as a third line (3L) or greater line treatment which is not received the Standard of Care (SOC) for patients with PD-L1 positive advanced GC/Gastroesophageal Junction Adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.

开始日期2022-04-07

申办/合作机构

Genome & Co.

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100 项与 PD-L1阳性胃腺癌相关的临床结果

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100 项与 PD-L1阳性胃腺癌相关的转化医学

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0 项与 PD-L1阳性胃腺癌相关的专利（医药）

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项与 PD-L1阳性胃腺癌相关的文献（医药）

2021-12-01·BMC Cancer2区 · 医学

LGR5 expression is associated with prognosis in poorly differentiated gastric adenocarcinoma

2区 · 医学

ArticleOA

作者: Soejima, Yuji ; Ehara, Takehito ; Uehara, Takeshi ; Kobayashi, Shota ; Iwaya, Mai ; Nakajima, Tomoyuki ; Kinugawa, Yasuhiro ; Ota, Hiroyoshi

AbstractBackgroundLeucine-rich repeat-containing G-protein-coupled receptor 5 (LGR5) is an important cancer stem cell marker in gastric cancer. However, no detailed studies are available on LGR5 expression in poorly differentiated gastric adenocarcinoma (PD-AC). Therefore, we investigated the relationship between LGR5 expression and clinicopathological data in PD-AC.MethodsLGR5 mRNA expression levels were quantified in 41 PD-AC specimens using a highly sensitive RNAscope in situ hybridization technique. Epstein–Barr virus (EBV) infection was also detected by EBV in situ hybridization.ResultsLGR5 expression levels were measured in 38 of 41 PD-AC cases, and 17 cases were identified as LGR5 high. The frequency of EBV positivity tended to be higher in the LGR5-low group than in the LGR5-high group (P = 0.0764). Furthermore, the frequency of vascular invasion tended to be higher in the LGR5-high group than in the LGR5-low group (P = 0.0764). The overall survival of PD-AC patients in the LGR5-high group was significantly lower than in the LGR5-low group (log-rank test, P = 0.0108). The Cox proportional hazard regression model revealed that the LGR5-low group (HR = 0.29; 95% CI: 0.11–0.74; P = 0.01) showed independently better OS for PD-AC.ConclusionsQuantifying the levels of LGR5 expression may facilitate defining prognosis in Japanese patients with PD-AC. Further study of LGR5 in this context is warranted.

2021-02-01·Archives of Pathology & Laboratory Medicine3区 · 医学

Immune Checkpoint Inhibitor–Induced Upper Gastrointestinal Tract Inflammation Shows Morphologic Similarities to, but Is Immunologically Distinct From, Helicobacter pylori Gastritis and Celiac Disease

3区 · 医学

Article

作者: Irshaid, Lina ; Robert, Marie E. ; Zhang, Xuchen

Context.—Immune checkpoint inhibitor (CPI) therapies are associated with multi-organ immune-related adverse events. Although colonic mucosal changes have been described, inflammatory changes incited by CPIs in the upper gastrointestinal tract have not been well characterized.Objective.—To investigate morphologic and immunologic changes incited by CPI therapy in the upper gastrointestinal tract.Design.—We compared the morphology and immune cell phenotype of gastric and duodenal biopsies from patients treated with anti–cytotoxic T-lymphocyte associated protein 4 (CTLA-4) or anti–programmed death receptor-1/programmed death ligand-1 (PD-1/PD-L1) antibodies with biopsies from patients with Helicobacter pylori gastritis, patients with celiac disease, and normal controls.Results.—Gastric biopsies from patients on CPIs showed chronic gastritis mimicking H pylori gastritis. However, CPI gastritis demonstrated greater numbers of CD8+ intraepithelial lymphocytes, less lamina propria inflammation, fewer plasma cells and CD20+ B cells, fewer lymphoid aggregates, and reduced CD4:CD8 ratio in both the lamina propria and the epithelial layer. There were no differences between anti–CTLA-4 and anti–PD-1/PD-L1 gastritis, except for more lymphoid aggregates in anti–PD-1/PD-L1 gastritis. Duodenal biopsies from patients on CPIs revealed chronic duodenitis with villous blunting, mimicking celiac disease. Compared with celiac disease, CPI duodenitis demonstrated higher prevalence of neutrophilic infiltrates and erosions, increased lamina propria CD3 and CD8 T cells, and reduced CD4:CD8 ratio. Upper gastrointestinal biopsies were more inflamed than concomitant colonic biopsies in the majority of patients.Conclusions.—The morphologic and immunophenotypic distinctions between CPI-associated upper gastrointestinal injuries and common infectious and autoimmune diseases may provide useful discriminators when clinicians are confronted with gastric and duodenal inflammatory changes in patients receiving CPI therapy.

2017-11-01·Clinical Lung Cancer2区 · 医学

Computed Tomography Features of Lung Adenocarcinomas With Programmed Death Ligand 1 Expression

2区 · 医学

Article

作者: Katsura, Masakazu ; Akamine, Takaki ; Okamoto, Tatsuro ; Matsubara, Taichi ; Shoji, Fumihiro ; Shimokawa, Mototsugu ; Takada, Kazuki ; Takamori, Shinkichi ; Haratake, Naoki ; Oda, Yoshinao ; Kozuma, Yuka ; Toyokawa, Gouji ; Maehara, Yoshihiko

INTRODUCTIONThe development of immune checkpoint inhibitors against programmed death 1 has paved the way for a new era of treatment of lung cancer. Programmed death-ligand 1 (PD-L1) is expected to predict the response of immune checkpoint inhibitors in lung cancer. Predicting PD-L1 expression using a noninvasive method before immunotherapy would, therefore, help identify patients for whom immunotherapy can be successful.PATIENTS AND METHODSA total of 394 patients with resected lung adenocarcinoma who had undergone preoperative thin-section computed tomography (CT) were analyzed for PD-L1 expression by immunohistochemistry and evaluated to determine the association between PD-L1 expression and CT characteristics, including convergence, surrounding ground glass opacity (GGO), air bronchogram, notching, pleural indentation, spiculation, and cavitation.RESULTSOf the 394 patients, 78 (19.8%) were positive and 316 (80.2%) were negative for PD-L1 expression. Univariate analysis demonstrated that PD-L1⁺ adenocarcinoma was significantly associated with the presence of convergence (P < .01), notching (P < .01), spiculation (P < .01), and cavitation (P < .01) and the absence of surrounding GGO (P < .01) compared with PD-L1^- cases. On multivariate analysis, the presence of convergence (P < .01) and cavitation (P < .01) and the absence of surrounding GGO (P = .02) and air bronchogram (P = .03) were significantly associated with PD-L1 expression.CONCLUSIONPD-L1⁺ adenocarcinoma cases showed convergence and cavitation more frequently than did PD-L1^- cases. In contrast, surrounding GGO and air bronchogram were observed less frequently in PD-L1⁺ cases than in PD-L1^- cases. These results will prove helpful in identifying PD-L1-expressing adenocarcinoma by CT before immunotherapy.

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