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Communications Biology 2025年第1期8卷 1-14页

作者： Elizondo, Diana M. Patel, Tushar P. Cole, Benjamin T. Jansujwicz, Eliza A. Chen, Jocelyn Hollis, Melanie C. Mitra, Apratim Yanovski, Jack A. Section on Growth and Obesity Division of Intramural Research Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health Bethesda MD United States Department of Biological Sciences University of Maryland Baltimore County Baltimore MD United States Bioinformatics and Scientific Programming Core Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health Bethesda MD United States

We investigated Transglutaminase 2 (TGM2) in high fat diet (HFD) obese mice, finding upregulated TGM2+ adipose tissue macrophages (ATMs) in HFD epididymal white adipose tissue (eWAT) compared to chow diet (CD) eWAT. Using Tgm2 CRISPR silencing, we examined TGM2 modulation of inflammation in vitro within bone marrow-derived macrophages (BMMs), as well as in co-cultured eWAT stromal vascular fraction (SVF) cells. Tgm2 silencing in BMMs led to increased pro-inflammation, compared to control. In contrast, in vitro exposure of eWAT SVF to recombinant TGM2 increased anti-inflammatory IL-10 secretion. However, IL-10 was not induced by recombinant TGM2 in CD activated CD4 + T cells, or in HFD-derived SVF CD4 + T cells. In vivo Tgm2 silencing in CD11b+ cells in HFD mice resulted in pro-inflammation in eWAT and serum, and increased adiposity and insulin resistance, suggesting that TGM2 + ATMs possess an anti-inflammatory role in obesity that is insufficient to reverse obesity-induced inflammation. © This is a U.S. Government work and not under copyright protection in the US;foreign copyright protection may apply 2025.

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A Simulation-free Group Sequential Design with Max-combo Tests in the Presence of Non-proportional Hazards

arXiv

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arXiv 2019年

作者： Wang, Lili Luo, Xiaodong Zheng, Cheng Department of Biotatistics University of Michigan Ann ArborMI United States Department of Biostatistics and Programming Research and Development Sanofi Us BridgewaterNJ United States

Non-proportional hazards (NPH) have been observed in many immuno-oncology clinical trials. Weighted log-rank tests (WLRT) with suitable weights can be used to improve the power of detecting the difference between survival curves in the presence of NPH. However, it is not easy to choose a proper WLRT in practice. A versatile maxcombo test was proposed to achieve the balance of robustness and efficiency, and has received increasing attention recently. Survival trials often warrant interim analyses due to their high cost and long durations. The integration and implementation of maxcombo tests in interim analyses often require extensive simulation studies. In this report, we propose a simulation-free approach for group sequential designs with the maxcombo test in survival trials. The simulation results support that the proposed method can successfully control the type I error rate and offer excellent accuracy and flexibility in estimating sample sizes, with light computation burden. Notably, our method displays strong robustness towards various model misspecifications and has been implemented in an R package for free access online. Copyright © 2019, The Authors. All rights reserved.

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9O Phase I/II, open-label, first-in-human study of the anti-GPC3 T cell engager SAR444200 in patients with advanced solid tumors: Updated safety and pharmacokinetic analysis

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ESMO Open 2025年 10卷 104165-104165页

作者： Almhanna, K. Hong, J.Y. Chenard-Poirier, M. Ryoo, B-Y. Lim, D.W-T. El-Khoueiry, A.B. Goh, B-C. Samol, J. Kefsi, A. Perez, R. Meng, R. Masciari, S. Abbadessa, G. Guillemin-Paveau, H. Lepine, L. Zhang, Y. Dumbrava, E.E. Medical Oncology Warren Alpert Medical School of Brown University Providence United States of America Hematology-Oncology Samsung Medical Center (SMC) Seoul Republic of Korea Gastrointestinal Cancer Unit Centre Intégré de Cancérologie - Chu de Québec Québec Canada Department of Oncology Asan Medical Center - University of Ulsan Seoul Republic of Korea Medical Oncology Department NCCS - National Cancer Centre Singapore Medical Oncology Division USC - Kenneth J. Norris Jr. Comprehensive Cancer Center Los Angeles United States of America Hematology-Oncology NCIS - National University Cancer Institute Singapore Singapore Medical Oncology Department National Healthcare Group - Tan Tock Seng Hospital Singapore Oncology Early Development Sanofi Vitry-sur-Seine France Immuno Modulatory Agents-Early Development Sanofi Bridgewater United States of America Research and Development Department Sanofi Cambridge United States of America Early Development in Oncology Sanofi Cambridge United States of America Oncology Early Development Sanofi Cambridge United States of America Pharmacokinetics/Pharmacodynamics VA Sanofi Vitry-sur-Seine France Pharmacokinetics Dynamics and Metabolism Sanofi Vitry-sur-Seine France Department of Biostatistics and Programming Sanofi Cambridge United States of America Investigational Cancer Therapeutics Department The University of Texas MD Anderson Cancer Center - Main Building Houston United States of America

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AB1033 UNDERSTANDING THE IMPACT OF BELIMUMAB ON EARLY (≤2 YEARS) SYSTEMIC LUPUS ERYTHEMATOSUS IN ADULTS: BeEARLY, A PHASE 4, PROSPECTIVE, OPEN-LABEL STUDY

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Annals of the Rheumatic Diseases 2024年 83卷 1837-1837页

作者： M. Petri K. Costenbader M. Mosca S. Collingborn R.A. Levy C. O’shea H.A. Quasny John Hopkins University School of Medicine Division of Rheumatology Baltimore MD United States of America Brigham & Women’s Hospital Division of Rheumatology Inflammation and Immunity Boston MA United States of America University of Pisa Department of Clinical and Experimental Medicine Pisa Italy Veramed Statistics and Programming Frankfurt Germany GSK Global Medical Affairs Collegeville PA United States of America GSK Rheumatology Global Medical Affairs Dublin Ireland GSK Research & Development Durham NC United States of America

Background: Approximately 40% of patients with systemic lupus erythematosus (SLE) develop organ damage within the first 5 years of diagnosis due to uncontrolled disease activity and cumulative steroid exposure, resulting in a greater risk of early mortality. [1] Timely intervention with disease-modifying biologics such as belimumab (BEL) in the early stages of SLE might modify the disease course and prevent irreversible organ damage while avoiding the need for high-dose glucocorticoids (GCs) or immunosuppressants (IS). Previous studies suggested that BEL may have benefit when used earlier in the course of the disease, especially in patients with minimal or no organ damage at baseline who received BEL within 2 years of classification. [2,3] However, the use of BEL early in the treatment pathway has been limited in clinical practice, with the majority of BEL use following the failure of ≥2 IS. Objectives: Present the design of the BeEARLY (BEL in Early SLE) study, which will evaluate the efficacy and safety of BEL in adult SLE patients with early disease. Methods: In this Phase 4, prospective, open-label, single-arm, 3-year clinical study (GSK Study 219240), approximately 350 adult patients with active, autoantibody-positive, early SLE (≤2 years since diagnosis) with no organ damage and with inadequate response to initial standard therapy (ST; with/without conventional IS) will be enrolled. Key eligibility criteria are shown in Table 1 . Eligible participants will receive open-label BEL 200 mg/week subcutaneously as an add-on to their initial ST for 52 weeks (Part A), with a long-term extension of up to 104 weeks (end of study is the safety follow-up visit after Week 156; Part B). Key primary and secondary endpoints are shown in Table 2 . Participants will be required to taper the average oral GC (OGC; prednisone equivalent) dose from Week 12 to ≤7.5 mg/day by Week 26, and to ≤5 mg/day by Week 48 at the discretion of the investigator if they continue to maintain stabl

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P.0508 Correlation between patient engagement with a digital medicine system and clinical symptom improvement

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European Neuropsychopharmacology 2021年 53卷 S374-S374页

作者： Cochran, J. Fang, H. Gallo, C. Le Peters-Strickland, T. Lindenmayer, J.P. Fowler, J.C. Otsuka Pharmaceutical Development & Commercialization- Inc. Data Science- Medical and Real World Data Analytics Princeton United States Otsuka Pharmaceutical Development & Commercialization- Inc. Biostatistics Princeton United States Otsuka Pharmaceutical Development & Commercialization- Inc. Clinical Programming Princeton United States Otsuka Pharmaceutical Development & Commercialization- Inc. Global Clinical Development Princeton United States New York University Grossman School of Medicine Department of Psychiatry New York United States

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7 Phase 3 Trial of an Oral CXCR4 Antagonist, Mavorixafor, for Treatment of Patients With WHIM Syndrome: Preliminary Results From Ongoing Open-Label Extension Period of Continuous Mavorixafor Treatment

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Clinical Immunology 2024年 262卷 109949-109949页

作者： Tarrant, Teresa Badolato, Raffaele Donadieu, Jean Dubuc, Susan Hu, Yanping Jiang, Honghua Li, Sunny Steiner, Deborah Yan, Tina Arbet-Engels, Christophe Associate Professor of Medicine Rheumatology and Immunology/Division of Rheumatology and Immunology Department of Medicine Duke University Durham NC USA Full Professor of Pediatrics Chair of Pediatrics ASST Spedali Civili Brescia/Department of Clinical and Experimental Sciences University of Brescia & ASST Spedali Civili Brescia Italy Pediatric Physician/CHU Paris Est - Hôpital d’Enfants Armand-Trousseau Paris France Senior Director Pharmacovigilance & Risk Management/X4 Pharmaceuticals Boston MA USA Director Clinical Research/X4 Pharmaceuticals Boston MA USA Senior Director Biostatistics/X4 Pharmaceuticals Boston MA USA Senior Director Statistical Programming/X4 Pharmaceuticals Boston MA USA Vice President Clinical Development/X4 Pharmaceuticals Boston MA USA Director Statistical Programming/X4 Pharmaceuticals Boston MA USA Chief Medical Officer/X4 Pharmaceuticals Boston MA USA

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VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up

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Annals of Oncology 2022年第9期33卷 986-987页

作者： S. Loibl J. Jassem A. Sonnenblick D. Parlier E. Winer J. Bergh R.D. Gelber E. Restuccia Y-H. Im C. Huang F. Dalenc I. Calvo M. Procter C. Caballero E. Clark H.L. Gomez Moreno J. Bliss G. Viale J. Bines M. Piccart Medicine and Research Dept. German Breast Group (GBG) Forschungs GmbH Neu-Isenburg Germany Oncology & Radiotherapy Medical University of Gdansk Gdansk Poland Oncology Department Tel Aviv Sourasky Medical Center-(Ichilov) Tel Aviv Israel Clinical Trials Support Unit Institut Jules Bordet Brussels Belgium Yale Cancer Center Yale University School of Medicine - Yale Cancer Center New Haven CT USA Department of Oncology-Pathology Karolinska Institutet and Breast Cancer Centre Cancer Theme Karolinska University Hospital Stockholm Sweden Biostatistics Dana Farber Cancer Institute Boston MA USA Product Development Oncology F. Hoffmann-La Roche Ltd Basel Switzerland Medicine Dept. Hematology/Medical Oncology Division Samsung Medical Center (SMC) - Sungkyunkwan University School of Medicine Seoul Republic of Korea Surgery Dept. NTUH - National Taiwan University Hospital Taipei Taiwan Oncologie 1A Institut Universitaire du Cancer Toulouse - Oncopole Toulouse France Breast Cancer Unit MD Anderson Cancer Center Madrid Madrid Spain Statistics and Programming Frontier Science Scotland Kincraig UK Medical Department Breast International Group (BIG) - AISBL Brussels Belgium Data Sciences - Data & Statistical Sciences (DSS) Roche Products Limited Welwyn Garden City UK Medicine Department INEN - Instituto Nacional de Enfermedades Neoplasicas Lima Peru Clinical Trials and Statistics Unit ICR - Institute of Cancer Research London UK Department of Oncology Università degli Studi di Milano Milan Italy Medical Oncology Department Instituto Nacional de Cancer - Research Center Rio de Janeiro Brazil Institut Jules Bordet Brussels Belgium

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1261TiP CARMEN-GC01: Phase II, open-label, single-arm study of tusamitamab ravtansine in combination with ramucirumab in pretreated patients with gastric or gastroesophageal junction adenocarcinoma (GA/GEJA)

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Annals of Oncology 2022年 33卷 S1124-S1124页

作者： F.M. Esposito J. Lee S.Y. Rha K.D. Penkov A. Moisseev M. Van Den Eynde H. Prenen M. Díez García M. Gumus T. Sagawa M. Nechaeva T. Kajiwara H. Harputluoglu L. Charbonnier S. Bensfia N. Yang D-Y. Oh Medical Oncology Department/ICMHO Hospital Clínic de Barcelona Barcelona Spain Department of Hematology-Oncology Samsung Medical Center Seoul Republic of Korea Department of Medical Oncology Yonsei Cancer Center Yonsei University Health System Seoul Republic of Korea Oncology Department Euromedservice St. Petersburg Russian Federation Medical Oncology and Gastroenterology Department Medical Clinic of NACPP Moscow Russian Federation Oncology and Gastroenterology Department Cliniques Universitaires Saint-Luc Brussels Belgium Oncology Department UZA Edegem Belgium Medical Oncology Department Hospital Universitario Vall d'Hebron Barcelona Spain Medical Oncology Department Istanbul Medeniyet University Istanbul Turkey Gastroenterology Department National Hospital Organization Hokkaido Cancer Center Sapporo Hokkaido Japan Clinical Oncological Dispensary State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Russian Federation Department of Gastrointestinal Medical Oncology National Hospital Organization Shikoku Cancer Center Matsuyama Ehime Japan Medical Oncology Department Inonu University Medical Faculty Inonu University Turgut Ozal Medical Center Malatya Turkey Biostatistics & Programming Sanofi Chilly-Mazarin France Clinical Development Sanofi Cambridge MA USA Clinical Development Sanofi Shanghai China Department of Internal Medicine Seoul National University Hospital Seoul Republic of Korea

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212MO AMEERA-3, a phase II study of amcenestrant (AMC) versus endocrine treatment of physician’s choice (TPC) in patients (pts) with endocrine-resistant ER+/HER2− advanced breast cancer (aBC)

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Annals of Oncology 2022年 33卷 S634-S635页

作者： S.M. Tolaney A. Chan K. Petrakova S. Delaloge M. Campone H. Iwata P. Peddi P.A. Kaufman E. de Kermadec Q. Liu P. Cohen G. Paux S-A. Im Medical Oncology Dana Farber Cancer Institute Boston MA USA School of Medicine Curtin University Perth WA Australia Departement of Comprehensive Cancer Care Masaryk Memorial Cancer Institute Brno South Moravian Czech Republic Department of Cancer Medicine Institut Gustave Roussy Villejuif France Medical Oncology Department Institut de cancérologie de l’Ouest Saint-Herblain France Breast Oncology Aichi Cancer Center Hospital Nagoya Aichi Japan Margie Petersen Breast Center Providence Saint John’s Cancer Institute Santa Monica CA USA Medicine University of Vermont - Larner College of Medicine Burlington VT USA Clinical Development Sanofi Cambridge MA USA Biostatistics & Programming Sanofi Cambridge MA USA Oncology Sanofi Vitry-sur-Seine France Clinical Sciences & Operations / Biostatistics & Programming Sanofi Cambridge MA USA Cancer Research Institute Seoul National University Hospital Seoul National University College of Medicine Seoul Republic of Korea

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TP009/#1495 A phase 2, open-label, single-arm, prospective, multi-center study of nab-sirolimus plus letrozole in advanced or recurrent endometrioid endometrial cancer

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International Journal of Gynecological Cancer 2023年 33卷 A249-A250页

作者： Lauren Dockery Anna Priebe Linda Duska Angela Green Cara Mathews Fernanda Musa David O’Malley Allison Puechl L.i. Ding Anita Schmid Willis Navarro Brian Slomovitz Kathleen Moore Stephenson Cancer Center Oklahoma University Health Gynecologic Oncology Oklahoma City USA Texas Oncology - Tyler USA University of Virginia - Charlottesville USA Memorial Sloan Kettering Cancer Center - New York USA Women and Infants Hospital - Providence USA Swedish Cancer Institute - Seattle USA The Ohio State Comprehensive Cancer Center Department of Obstetrics and Gynecology Columbus USA Atrium Health Levine Cancer Institute Gynecologic Cancer Charlotte USA Aadi Bioscience Biostatistics Programming and Data Management Pacific Palisades USA Aadi Bioscience Clinical Science Pacific Palisades USA Aadi Bioscience Clinical Development and Pharmacovigilance Pacific Palisades USA Mount Sinai Medical Center Gynecologic Oncology Miami Beach USA

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