A5043165289- TGF-β signaling in diseases
- Pancreatic and Hepatic Oncology Research
- Cancer Immunotherapy and Biomarkers
- Cancer Research and Treatments
- Gastric Cancer Management and Outcomes
- Colorectal Cancer Treatments and Studies
- Cholangiocarcinoma and Gallbladder Cancer Studies
- Lung Cancer Treatments and Mutations
- Lung Cancer Research Studies
- Peptidase Inhibition and Analysis
- Cancer Cells and Metastasis
- Colorectal and Anal Carcinomas
- Lung Cancer Diagnosis and Treatment
- Gastrointestinal Tumor Research and Treatment
- Cancer-related gene regulation
- Radiomics and Machine Learning in Medical Imaging
- Ferroptosis and cancer prognosis
- Esophageal Cancer Research and Treatment
- Polyomavirus and related diseases
- Full-Duplex Wireless Communications
- Gallbladder and Bile Duct Disorders
- Ovarian function and disorders
- Antenna Design and Analysis
- Sarcoma Diagnosis and Treatment
- Oral and gingival health research
Merck (Germany)
2014-2023
Onkologikoa
2019
Mayo Clinic in Arizona
2019
Abstract Purpose: M7824 (MSB0011359C) is an innovative first-in-class bifunctional fusion protein composed of a mAb against programmed death ligand 1 (PD-L1) fused to TGFβ “trap.” Experimental Design: In the 3+3 dose-escalation component this phase I study (NCT02517398), eligible patients with advanced solid tumors received at 1, 3, 10, or 20 mg/kg once every 2 weeks until confirmed progression, unacceptable toxicity, trial withdrawal; in addition, cohort initial 0.3 dose evaluate...
Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) or its methylester [methyl-5-aminolaevulinate (MAL) 5-amino-4-oxopentanoate] was recently ranked as first-line for the treatment of actinic keratosis (AK) and is an accepted therapeutic option neoplastic skin diseases. BF-200 ALA (Biofrontera Bioscience GmbH, Leverkusen, Germany) a gel formulation nanoemulsion AK which overcomes previous problems instability improves penetration.To evaluate efficacy safety PDT AKs in comparison...
Patients with biliary tract cancer (BTC) have poor prognosis few treatment options. Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain transforming growth factor (TGF)-βRII receptor (a TGF-β 'trap') fused to human IgG1 antibody blocking programmed death ligand 1 (PD-L1), has shown clinical efficacy in multiple solid tumors.In this phase I, open-label trial expansion cohort, Asian patients BTC whose disease progressed after first-line...
Aim: This retrospective study of patients in the USA with metastatic Merkel cell carcinoma (mMCC) aimed to assess patient responses second-line and later (2L+) first-line (1L) chemotherapy. Patients & methods: Out 686 MCC identified The US Oncology Network, 20 67 mMCC qualified for 2L+ 1L study, respectively; primary analysis population was restricted immunocompetent patients. Results: In population, objective response rate (ORR) 28.6%, median duration (DOR) 1.7 months progression-free...
// Jürgen C. Becker 1, 2, 15 , Eva Lorenz 3, 14 Selma Ugurel 2 Thomas K. Eigentler 4 Felix Kiecker 5 Claudia Pföhler 6 Ivonne Kellner 7 Friedegund Meier 8, 16 Katharina Kähler 9 Peter Mohr 10 Carola Berking 11 Gabriele Haas Christoph Helwig 12 Dina Oksen Dirk Schadendorf Lisa Mahnke 13 and Murtuza Bharmal 1 Translational Skin Cancer Research (TSCR), German Center (DFKZ) Partner Site Essen/Düsseldorf, Essen University Hospital, 45147, Essen, Germany Department of...
Background We report the clinical activity and safety of bintrafusp alfa, a first-in-class bifunctional fusion protein composed extracellular domain transforming growth factor β (TGF-β)RII receptor (a TGF-β ‘trap’) fused to human IgG1 monoclonal antibody blocking programmed death-ligand 1 (PD-L1), in patients with heavily pretreated squamous cell carcinoma head neck (SCCHN). Methods In this phase I dose-expansion cohort, advanced SCCHN not amenable curative therapy that progressed/recurred...
7500 Background: L-BLP25 is a MUC1 antigen specific cancer immunotherapy. We report results from the phase III START study of in patients (pts) not progressing after primary chemoradiotherapy (CRT) for stage NSCLC. Methods: From Jan 2007 to Nov 2011, 1513 pts with unresectable NSCLC that did progress CRT (platinum based chemo and ≥50 Gy) were randomized (2:1; double-blind) (806 µg lipopeptide) or placebo (PBO) SC weekly x 8 then Q6 weeks until disease progression withdrawal. Cyclophosphamide...
Abstract Lessons Learned Bintrafusp alfa had a manageable safety profile and demonstrated preliminary clinical activity in heavily pretreated patients with solid tumors (including hepatocellular carcinoma) no or limited treatment options. Findings from this study suggest bintrafusp may be novel therapeutic approach for advanced tumors. Additional trials are needed to further explore efficacy of specific tumor types. Background is first-in-class bifunctional fusion protein composed the...
Esophageal adenocarcinoma patients have limited treatment options. TGF-β can be upregulated in esophageal adenocarcinoma, and blocking this pathway may enhance clinical response to PD-(L)1 inhibitors. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain TGF-βRII receptor (a "trap") fused human IgG1 mAb PD-L1.
Abstract Purpose: Patients with advanced gastric/gastroesophageal junction cancer (GC/GEJC) have limited treatment options after first-line therapy. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain TGFβRII receptor (a TGFβ “trap”) fused to human IgG1 antibody against programmed death ligand 1 (PD-L1), potentially offering new approach for these patients. We report results bintrafusp in GC/GEJC. and Methods: Asian patients recurrent GC/GEJC...
Several programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) assays have been developed independently within clinical programs for therapeutic anti-programmed cell death protein (anti-PD-1) or PD-L1 antibodies, necessitating assessment of assay comparability. We characterized the Dako IHC 73-10 used in trials avelumab (anti-PD-L1) bintrafusp alfa (M7824; bifunctional immunotherapy) and compared it with 22C3 pharmDx assay, an approved companion diagnostic pembrolizumab monotherapy...
Abstract Background Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain transforming growth factor beta receptor II (a TGF-β “trap”) fused to human immunoglobulin G1 monoclonal antibody blocking programmed cell death 1 ligand (PD-L1). We report efficacy and safety in patients with non-small lung cancer (NSCLC) that progressed following anti-PD-(L)1 therapy. Materials Methods In this expansion cohort NCT02517398—a global, open-label, phase I...
Patients with esophageal squamous cell carcinoma (SCC) have limited treatment options. Blocking transforming growth factor-β (TGFβ), which can be overexpressed in these tumors, may enhance responses to programmed death protein 1/programmed death-ligand 1 [PD-(L)1] inhibitors. Bintrafusp alfa is a first-in-class bifunctional fusion composed of the extracellular domain TGFβ receptor II (TGFβRII) (a "trap") fused human IgG1 monoclonal antibody blocking PD-L1.The objective this study was...
3007 Background: Therapies targeting PD-1/L1 have produced response rates of 15-20% in patients (pts) with HPV associated cancers (HAC) including cervical (cerv), anal or head and neck squamous cell carcinoma (HNSCC). Another potential target for these diseases is transforming growth factor-β (TGF-β) as genome wide association studies HPV+ shown TGF-β to be significantly overexpressed. M7824 a bifunctional fusion protein PD-L1 comprised human IgG1 monoclonal antibody against fused 2...
For patients with recurrent glioblastoma (rGBM), there are few options following treatment failure radiotherapy plus temozolomide. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain TGF-βRII receptor (a TGF-β "trap") fused to human IgG1 antibody blocking PD-L1.In this phase I, open-label expansion cohort (NCT02517398), rGBM that progressed after temozolomide received bintrafusp 1200 mg Q2W until disease progression, unacceptable toxicity, or...
3006 Background: M7824 (MSB0011359C) is a novel bifunctional fusion protein comprised of fully human IgG1 monoclonal antibody against programmed death ligand 1 (PD-L1) fused to the soluble extracellular domain transforming growth factor-β (TGF-β) receptor II, which acts as TGF-β trap. We report preliminary data from phase trial in patients (pts) with advanced solid tumors. Methods: NCT02517398 1, open-label, 3+3 dose-escalation study. Eligible pts receive at 3, 10, or 20 mg/kg Q2W until...
Abstract Background: TGF-β pathway dysregulation may play a critical role in carcinogenesis and immune evasion HPV-associated cancers (HACs), including anal, cervical, p16+ squamous cell carcinoma of the head neck (SCCHN). Targeting this also enhance clinical response to PD-(L)1 antibodies. M7824 is an innovative first-in-class bifunctional fusion protein composed two extracellular domains TGF-βRII (a “trap”) fused with human IgG1 monoclonal antibody against PD-L1. In dose-escalation cohort...
764 Background: Inhibiting the transforming growth factor β (TGF-β) pathway, which plays a key role in tumor immunosuppression, may enhance response to programmed death 1/programmed ligand 1 (PD-1/PD-L1) monoclonal antibodies (mAbs). M7824 (MSB0011359C) is an innovative first-in-class bifunctional fusion protein composed of mAb against PD-L1 fused with extracellular domain TGF-β receptor II, serves as “trap.” We report results patients (pts) heavily pretreated colorectal cancer (CRC), area...
762 Background: Inhibiting the transforming growth factor β (TGF-β) pathway, which plays a key role in tumor immunosuppression, may enhance response to programmed death 1/programmed ligand 1 (PD-1/PD-L1) monoclonal antibodies (mAbs). M7824 (MSB0011359C) is an innovative first-in-class bifunctional fusion protein composed of mAb against PD-L1 fused with extracellular domain TGF-β receptor II, serves as “trap.” We report results Asian patients (pts) advanced solid tumors. Methods: NCT02699515...
e20581 Background: Response to anti–PD-L1/PD-1 therapy in patients with NSCLC has been associated tumor PD-L1 expression. Avelumab is a fully human anti‒PD-L1 IgG1 antibody that shown antitumor activity advanced NSCLC, trend for greater efficacy PD-L1+ vs PD-L1– tumors, as assessed using proprietary assay development (Dako, Carpinteria, CA; based on clone 73-10, Merck KGaA, Darmstadt, Germany). This study compares the analytical performance of 73-10 FDA-approved IHC 22C3 pharmDx diagnostic...