Matthew D. Galsky
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View article: 1318 Phase 1 clinical data show FX-909, a first-in-class oral PPARG inhibitor, drives immune modulation and pro-inflammatory cytokine induction in IO-experienced patients with advanced urothelial carcinoma
1318 Phase 1 clinical data show FX-909, a first-in-class oral PPARG inhibitor, drives immune modulation and pro-inflammatory cytokine induction in IO-experienced patients with advanced urothelial carcinoma Open
View article: MON-524 The Impact of SGLT2 Inhibitors on Adverse Genitourinary Effects in Prostate Cancer Survivors With Diabetes
MON-524 The Impact of SGLT2 Inhibitors on Adverse Genitourinary Effects in Prostate Cancer Survivors With Diabetes Open
Disclosure: D. Nudelman: None. M. Galsky: Janssen Research & Development Company, Merck, Seagen, Bristol-Myers Squibb, Gilead Sciences, Pfizer, Inc., Curis, AstraZeneca, Novartis, Abbvie, Janssen Oncology, Genentech, Inc., Bicycle Therapeu…
View article: Prostate cancer in situ autovaccination with the intratumoral viral mimic poly-ICLC: Modulating the cold tumor microenvironment
Prostate cancer in situ autovaccination with the intratumoral viral mimic poly-ICLC: Modulating the cold tumor microenvironment Open
This work was funded by the Arthur M. Blank Family Foundation.
View article: A Pilot Study of the Combination of 5-Azacitidine and All-trans Retinoic Acid in Biochemically Recurrent Prostate Cancer.
A Pilot Study of the Combination of 5-Azacitidine and All-trans Retinoic Acid in Biochemically Recurrent Prostate Cancer. Open
Purpose: Biochemical recurrence (BCR) after definitive local therapy remains a major clinical challenge in prostate cancer (PCa), with heterogeneous disease trajectories and few established strategies to delay further progression without p…
View article: SGNDV-001: disitamab vedotin with pembrolizumab in HER2-expressing locally advanced or metastatic urothelial carcinoma
SGNDV-001: disitamab vedotin with pembrolizumab in HER2-expressing locally advanced or metastatic urothelial carcinoma Open
The phase 3 trial SGNDV-001 (C5731001; NCT05911295) is evaluating disitamab vedotin (HER2-directed antibody-drug conjugate) with pembrolizumab compared with chemotherapy in treatment-naive patients with HER2-expressing la/mUC. Dual primary…
View article: Author Correction: Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial
Author Correction: Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial Open
View article: Protocol for Retrospective Analysis of Circulating and Urine Tumor DNA Biomarkers in HCRN GU16-257: A Phase 2 Trial of Gemcitabine, Cisplatin, and Nivolumab with Selective Bladder Sparing in Muscle-Invasive Bladder Cancer v1
Protocol for Retrospective Analysis of Circulating and Urine Tumor DNA Biomarkers in HCRN GU16-257: A Phase 2 Trial of Gemcitabine, Cisplatin, and Nivolumab with Selective Bladder Sparing in Muscle-Invasive Bladder Cancer v1 Open
HCRN GU16-257 was a prospective phase 2 trial evaluating gemcitabine, cisplatin, and nivolumab as organ-sparing treatment for muscle-invasive bladder cancer (MIBC). The trial enrolled 76 patients with cisplatin-eligible cT2-T4aN0M0 urothel…
View article: Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial
Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial Open
View article: Characterization of Patients with Lymph Node Only Metastatic Urothelial Carcinoma Treated with Nivolumab Plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone from the CheckMate 901 Trial
Characterization of Patients with Lymph Node Only Metastatic Urothelial Carcinoma Treated with Nivolumab Plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone from the CheckMate 901 Trial Open
Nivolumab (NIVO) plus gemcitabine-cisplatin (GC) demonstrated deep, durable responses in patients with untreated unresectable or metastatic urothelial carcinoma (mUC) with superior overall (OS) and progression-free (PFS) survival versus GC…
View article: Table S1 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S1 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S1 shows the representativeness of participants enrolled in this study.
View article: Table S9 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S9 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S9 shows pathways that are differentially expressed pre-treatment between patients who achieved disease control and those who did not from gene set enrichment analysis of RNA-Seq data.
View article: Table S4 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S4 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S4 summarizes exposure to the study drugs in Cohort B.
View article: Table S5 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S5 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S5 summarizes exposure to the study drugs in Cohort C.
View article: Table S2 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S2 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S2 shows the antibody panel used for CyTOF experiments.
View article: Table S7 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S7 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S7 summarizes demographic and baseline disease characteristics by 6-month disease control status.
View article: Table S3 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S3 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S3 summarizes exposure to the study drugs in Cohort A.
View article: Table S6 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S6 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S6 lists demographics, baseline disease characteristics, and outcomes for patients who achieved disease control.
View article: Table S8 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Table S8 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Table S8 shows the biopsy location and specimen type for tumor biopsy samples used for RNA-seq analysis.
View article: Figure S2 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Figure S2 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Figure S2 shows the percentage change in PSA from baseline for Cohorts A, B, and C. Values are capped at 200% for visualization purposes. The dashed horizontal line represents a 50% decrease in PSA. For Cohort C, the vertical gray line at …
View article: Data from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Data from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Purpose:Current immune checkpoint therapies offer limited benefits for metastatic castration-resistant prostate cancer. Novel combinations may enhance immunotherapy efficacy.Patients and Methods:We conducted an open-label, noncomparative p…
View article: Figure S1 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Figure S1 from Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer Open
Figure S1 shows the gating strategy for mass cytometry (CyTOF).
View article: Data from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Data from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Immunotherapies like immune checkpoint inhibitors (ICI) have changed the standard of care for patients with cancer, often leading to durable responses. However, many patients remain or become refractory to ICIs owing to factors such as a l…
View article: Supp Fig7+ Legend from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Supp Fig7+ Legend from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Supplementary Fig7. Characterizing peripheral cellular immune environment in patients receiving PGV001. Multicolor flowcytometry performed to phenotype circulating immune cells in patients and healthy donors (HD). PID-017 was excluded from…
View article: Supplementary Table3 from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Supplementary Table3 from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Supplementary Table3: List of mutated peptide IDs and peptide sequence in each patients’ vaccine
View article: Supp Fig3 + Legend from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Supp Fig3 + Legend from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Supplementary Fig3. Neoantigen specific antibody responses induced by PGV001. Patient plasma was subjected to seromics by ELISA using linear SLPs in the vaccines. N=12 patients. PID-017 excluded from analysis due to high background. a) Sta…
View article: Supplementary Table2 from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Supplementary Table2 from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Supplementary Table2 – Variant count per patient
View article: Supp Fig5+ Legend from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Supp Fig5+ Legend from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Supplementary Fig5. TCR sequencing on neoantigen reactive T cells in patient PBMCs a) (Top) Depiction of methodology utilized to generate ex vivo and in vitro expanded and stimulated (IVS) T cell samples from screen, week 8 (W8) and week 2…
View article: Supp Fig1+ Legend from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Supp Fig1+ Legend from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Supplementary Fig1. PGV001 feasibility and recurrence free survival a) Survival plot depicting overall survival (OS). N=12. Median survival depicted by vertical dotted line b) Survival plot depicting recurrence free survival (RFS). Median …
View article: Supplementary Table5 from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Supplementary Table5 from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Supplementary Table5: Cellular Immunophenotyping antibody panels
View article: Supplementary Table1. from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting
Supplementary Table1. from PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting Open
Supplementary Table1. Staging at time of enrollment, adjuvant treatment following curative intent treatment until the end of vaccination and vaccination timing