Kohei Shitara
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View article: 496 CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer from the Phase 2 randomized ASPEN-06 trial
496 CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer from the Phase 2 randomized ASPEN-06 trial Open
View article: Modeling and addressing on-target/off-tumor toxicity of claudin 18.2 targeted immunotherapies
Modeling and addressing on-target/off-tumor toxicity of claudin 18.2 targeted immunotherapies Open
Successfully extending immunotherapies to solid tumors involves addressing several key challenges, importantly the "antigen dilemma", the expression of a solid tumor target antigen on the normal tissue of tumor origin. Claudin 18.2 (CLDN18…
View article: Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers
Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers Open
www.clinicaltrials.gov identifier is NCT06324357.
View article: Supplementary Table S2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Representativeness of study participants
View article: Supplementary Table S1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
The antibodies list used for TIL analysis
View article: Supplementary Table S3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Post-progression anti-cancer therapy of the nivolumab monotherapy
View article: Supplementary Table S1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
The antibodies list used for TIL analysis
View article: Supplementary Table S2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Representativeness of study participants
View article: Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules
Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules Open
The classical cadherin (CDH), claudin (CLDN) and nectin families of transmembrane-type adhesion molecules are located at adherens or tight junctions in epithelial cells but diffuse to the nonjunctional cell surface in solid tumors with epi…
View article: Supplementary Table S3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Post-progression anti-cancer therapy of the nivolumab monotherapy
View article: Figure 1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Figure 1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Patient disposition.
View article: Table 2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Table 2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Summary of responses (RES).
View article: Figure 3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Figure 3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Tumor response, OS, and PFS. A and B, A summary of (A) best reduction and (B) percent change from baseline in the sum of the diameters of target tumors in each patient with NSCLC treated with nivolumab. C…
View article: Table 1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Table 1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Patient baseline characteristics (FAS).
View article: Supplementary Table S1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S1 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
The antibodies list used for TIL analysis
View article: Supplementary Table S2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Representativeness of study participants
View article: Figure 2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Figure 2 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Evaluation of PD-1+ Treg cells and PD-1+CD8+ T cells. A and B, The scatter plots that show PD-1 positivity (%) in CD8+ T cells and Treg cells in patients with (A) NSCLC and (…
View article: Table 3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Table 3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Summary of conventional biomarkers (RES, ad hoc analysis).
View article: Table 4 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Table 4 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Summary of AEs and TRAEs (SAF).
View article: Supplementary Table S3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Supplementary Table S3 from Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Post-progression anti-cancer therapy of the nivolumab monotherapy
View article: Chronological survival improvement over time with oxaliplatin-based chemotherapy plus targeted agents in metastatic colorectal cancer: An ARCAD database study
Chronological survival improvement over time with oxaliplatin-based chemotherapy plus targeted agents in metastatic colorectal cancer: An ARCAD database study Open
We demonstrated progressive improvements in survival outcomes for patients with metastatic colorectal cancer receiving first-line oxaliplatin-based chemotherapy plus molecular targeted agents. The findings highlight the importance of bioma…
View article: Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents
Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents Open
PURPOSE Phase I trials of anticancer agents have evolved after advances in tumor molecular biology and immunology. However, information on phase I trials targeting multiple solid tumors remains limited. We analyzed recent trends of phase I…
View article: Characterization of early-onset gastritis during zolbetuximab-containing chemotherapy in CLDN18.2-positive gastric cancer
Characterization of early-onset gastritis during zolbetuximab-containing chemotherapy in CLDN18.2-positive gastric cancer Open
View article: Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study Open
Purpose: It is challenging to identify the appropriate patients who benefit from anti–PD-1/PD-L1 monotherapy. For predicting effectiveness of anti–PD-1/PD-L1 monotherapy, this open-label phase II study (ONO-4538-88) evaluated the potential…
View article: Development and validation of a prognostic model incorporating patient reported outcomes for advanced gastric and esophageal carcinoma (AGOC) using individual patient data from two AGITG randomized clinical trials
Development and validation of a prognostic model incorporating patient reported outcomes for advanced gastric and esophageal carcinoma (AGOC) using individual patient data from two AGITG randomized clinical trials Open
Background We developed and validated a prognostic model incorporating readily accessible clinicopathological data and specific patient-reported outcomes (PROs). Methods We used data from two randomized trials comparing regorafenib to plac…
View article: Impact of Human Epidermal Growth Factor Receptor 2 in Patients With Metastatic Colorectal Cancer Treated With Chemotherapy Plus Bevacizumab or Anti-EGFRs: Exploratory Analysis of Eight Randomized Trials
Impact of Human Epidermal Growth Factor Receptor 2 in Patients With Metastatic Colorectal Cancer Treated With Chemotherapy Plus Bevacizumab or Anti-EGFRs: Exploratory Analysis of Eight Randomized Trials Open
PURPOSE Human epidermal growth factor receptor 2 (HER2) amplification/overexpression (HER2-pos) is detected in 5% of RAS/BRAF wild-type metastatic colorectal cancers (mCRCs). Its prognostic/predictive role in terms of benefit from anti-EGF…
View article: Impact of claudin 18.2 expression on treatment outcomes of first-line immunochemotherapy in patients with HER2-negative, proficient MMR, PD-L1 CPS ⩾1 metastatic gastric/gastroesophageal junction cancer
Impact of claudin 18.2 expression on treatment outcomes of first-line immunochemotherapy in patients with HER2-negative, proficient MMR, PD-L1 CPS ⩾1 metastatic gastric/gastroesophageal junction cancer Open
Background: The effect of claudin 18.2 (CLDN18.2) expression on the outcomes of a first-line immune checkpoint inhibitor (ICI)-containing chemotherapy (ICI-chemo) in patients with human epidermal growth factor receptor 2 (HER2)-negative, p…
View article: Dynamic modulation of claudin18.2 expression and remodeling of the tumor microenvironment in gastric cancer during chemo-immunotherapy
Dynamic modulation of claudin18.2 expression and remodeling of the tumor microenvironment in gastric cancer during chemo-immunotherapy Open
Background Claudin 18.2 (CLDN18.2) is a tight junction protein retained in malignant transformation of gastric cancer (GC) and is a promising therapeutic target. Despite the clinical benefit of zolbetuximab in CLDN18.2-positive tumors, the…
View article: Clinical Pharmacology Profile of the Claudin 18.2 Antibody Zolbetuximab
Clinical Pharmacology Profile of the Claudin 18.2 Antibody Zolbetuximab Open
View article: A case of gastritis developing in a patient receiving zolbetuximab-containing chemotherapy for CLDN18.2-positive advanced gastric cancer
A case of gastritis developing in a patient receiving zolbetuximab-containing chemotherapy for CLDN18.2-positive advanced gastric cancer Open