Ezra E.W. Cohen
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View article: A Randomized Multi-institutional Phase II Trial of Everolimus as Adjuvant Therapy in Patients with Locally Advanced Squamous Cell Cancer of the Head and Neck.
A Randomized Multi-institutional Phase II Trial of Everolimus as Adjuvant Therapy in Patients with Locally Advanced Squamous Cell Cancer of the Head and Neck. Open
PURPOSE: Investigate whether adjuvant everolimus, an mTOR inhibitor, improves progression-free survival (PFS) in advanced-stage head and neck squamous cell carcinoma (HNSCC) and provide outcomes related to correlative biological factors as…
View article: Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study
Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study Open
PURPOSE TrilynX was a randomized, double-blind, phase III study evaluating the addition of xevinapant (an inhibitor of apoptosis proteins inhibitor) or placebo to chemoradiotherapy (CRT) in patients with unresected locally advanced squamou…
View article: The spontaneous neoantigen-specific CD4 <sup>+</sup> T-cell response to a growing tumor is functionally and phenotypically diverse
The spontaneous neoantigen-specific CD4 <sup>+</sup> T-cell response to a growing tumor is functionally and phenotypically diverse Open
Background CD4 + T cells play a critical role in the positive and negative regulation of cellular immunity through the many functional subsets they comprise. The progressive growth of immunogenic tumors which nonetheless generate mutation-…
View article: Efficacy and safety of one-time autologous tumor-infiltrating lymphocyte cell therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma
Efficacy and safety of one-time autologous tumor-infiltrating lymphocyte cell therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma Open
Background Recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) has a high recurrence rate after first-line immunotherapy or chemoimmunotherapy. The presence of a high density of tumor-infiltrating lymphocytes (TILs) i…
View article: Development and validation of the Immune Profile Score (IPS), a novel multiomic algorithmic assay for stratifying outcomes in a real-world cohort of patients with advanced solid cancer treated with immune checkpoint inhibitors
Development and validation of the Immune Profile Score (IPS), a novel multiomic algorithmic assay for stratifying outcomes in a real-world cohort of patients with advanced solid cancer treated with immune checkpoint inhibitors Open
Background Immune checkpoint inhibitors (ICIs) have transformed the oncology treatment landscape. Despite substantial improvements for some patients, the majority do not benefit from ICIs, indicating a need for predictive biomarkers to bet…
View article: The spontaneous neoantigen-specific CD4<sup>+</sup>T cell response to a growing tumor is functionally and phenotypically diverse
The spontaneous neoantigen-specific CD4<sup>+</sup>T cell response to a growing tumor is functionally and phenotypically diverse Open
CD4 + T cells play critical roles in the positive and negative regulation of cellular immunity through the many functional subsets they comprise. The progressive growth of immunogenic tumors which nonetheless generate mutation-specific T c…
View article: Development and validation of the Immune Profile Score (IPS), a novel multi-omic algorithmic assay for stratifying outcomes in a real-world cohort of advanced solid cancer patients treated with immune checkpoint inhibitors
Development and validation of the Immune Profile Score (IPS), a novel multi-omic algorithmic assay for stratifying outcomes in a real-world cohort of advanced solid cancer patients treated with immune checkpoint inhibitors Open
Background Immune checkpoint inhibitors (ICIs) have transformed the oncology treatment landscape. Despite substantial improvements for some patients, the majority do not benefit from ICIs, indicating a need for predictive biomarkers to bet…
View article: Actionable Structural Variant Detection via RNA-NGS and DNA-NGS in Patients With Advanced Non–Small Cell Lung Cancer
Actionable Structural Variant Detection via RNA-NGS and DNA-NGS in Patients With Advanced Non–Small Cell Lung Cancer Open
Importance The National Comprehensive Cancer Network (NCCN) guidelines for non–small cell lung cancer suggest that RNA next-generation sequencing (NGS) may improve the detection of fusions and splicing variants compared with DNA-NGS alone.…
View article: Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study
Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study Open
Background Despite advances in cancer care and detection, >65% of patients with squamous cell cancer of the head and neck (HNSCC) will develop recurrent and/or metastatic disease. The prognosis for these patients is poor with a 5-year over…
View article: Low PD-L1 expression, MAP2K2 alterations, and enriched HPV gene signatures characterize brain metastases in head and neck squamous cell carcinoma
Low PD-L1 expression, MAP2K2 alterations, and enriched HPV gene signatures characterize brain metastases in head and neck squamous cell carcinoma Open
HNSCC patients with BM frequently have oropharyngeal primary sites and are HPV+. Common molecular alterations in BM samples, including targetable PIK3CA and ATM, were identified. MAP2K2 alterations were enriched and densities of immune cel…
View article: Data from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Data from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Purpose: Eganelisib (IPI-549) is a first-in-class, orally administered, highly selective phosphoinositide-3-kinase (PI3K)-γ inhibitor with anti-tumor activity alone and in combination with programmed cell death protein 1/ligand 1 (PD-1/PD-…
View article: Table S3 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Table S3 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Summary of anti-tumor activity endpoints in patients treated with eganelisib combination therapy by tumor type
View article: Table S4 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Table S4 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Representativeness of Study Participants
View article: Censoring rules 3 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Censoring rules 3 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Study IPI-549-01 progression-free survival censoring rules for efficacy analyses
View article: Inclusion and Exclusion Criteria 1 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Inclusion and Exclusion Criteria 1 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Study IPI-549-01 full protocol inclusion and exclusion criteria
View article: Methodology and Criteria for MDSCs 2 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Methodology and Criteria for MDSCs 2 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Study IPI-549-01 methodology and criteria for assessing MDSCs
View article: Methodology and Criteria for MDSCs 2 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Methodology and Criteria for MDSCs 2 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Study IPI-549-01 methodology and criteria for assessing MDSCs
View article: Table S2 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Table S2 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Summary of anti-tumor activity endpoints in patients treated with eganelisib monotherapy and combination therapy
View article: Table S2 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Table S2 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Summary of anti-tumor activity endpoints in patients treated with eganelisib monotherapy and combination therapy
View article: Table S1 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Table S1 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Geometric mean (geometric CV%) of eganelisib PK parameters in patients with solid tumors in the monotherapy cohort
View article: Table S4 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Table S4 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Representativeness of Study Participants
View article: Inclusion and Exclusion Criteria 1 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Inclusion and Exclusion Criteria 1 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Study IPI-549-01 full protocol inclusion and exclusion criteria
View article: Table S1 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Table S1 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Geometric mean (geometric CV%) of eganelisib PK parameters in patients with solid tumors in the monotherapy cohort
View article: Censoring rules 3 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Censoring rules 3 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Study IPI-549-01 progression-free survival censoring rules for efficacy analyses
View article: Table S3 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Table S3 from Eganelisib, a First-in-Class PI3K-γ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial Open
Summary of anti-tumor activity endpoints in patients treated with eganelisib combination therapy by tumor type
View article: Multicenter validation of an assay to predict anti-PD-1 disease control in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma: The PREDAPT Study
Multicenter validation of an assay to predict anti-PD-1 disease control in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma: The PREDAPT Study Open
Background Despite advances in cancer care and detection, more than 65% of patients with squamous cell cancer of the head and neck (HNSCC) will develop recurrent and/or metastatic disease. The prognosis for these patients is poor with a 5 …
View article: Metastatic gastric cancer target lesion complete response with Claudin18.2-CAR T cells
Metastatic gastric cancer target lesion complete response with Claudin18.2-CAR T cells Open
Treatment of hematologic malignancies with patient-derived anti-CD19 chimeric antigen receptor (CAR) T-cells has demonstrated long-term remissions for patients with otherwise treatment-refractory advanced leukemia and lymphoma. Conversely,…