PUBLICATION ONLY: The Patient Experience with Belantamab Mafodotin: Perspectives of Patients Receiving Treatment in Clinical Trials and in the Real-World, 12. 4. Mannino D, Siddall J, Small M, et al. Singh AK, et al. P1445. Silver J, Deb A, Packnett E, et al. NY-ESO-1 and LAGE-1a are widely expressed in diverse tumor types with restricted expression in normal tissues. Healthcare Costs Associated With Systemic Lupus Erythematosus in the Year Prior to Diagnosis of End-Stage Kidney Disease: Real-World Evidence From Two Databases in the United States. Please download the thermostability information for full details. Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-. www.fda.gov/medwatch. Reasons why patients with severe asthma discontinue biologic treatment. Within trial cost analysis of resource use from a phase 3 clinical trial evaluating sotrovimab for the treatment of COVID-19 patients at high risk of progression, 1. POSTER: Patterns of initial ovarian cancer recurrence on niraparib maintenance monotherapy in patients with no baseline evidence of disease following first-line chemotherapy: PRIMA/ENGOT-OV26/GOG-3012 ad-hoc subgroup analysis, 7. Poster No. 6. Stimulator of interferon genes (STING) is a key adapter molecule that mediates sensing of cytosolic DNA and activates T-celldependent tumor immunity. [Oral presentation available here; Abstract A4209]. Targeting B-cell maturation antigen in multiple myeloma. Corbridge T, Deb A, Germain G, et al. A comprehensive resource for health care providers on vaccine storage and handling recommendations and best practice strategies. A Phase 2, Single Arm, Open Label Study to evaluate the safety and efficacy of niraparib combined with bevacizumab as maintenance treatment in patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following frontline platinum-based chemotherapy with bevacizumab (OVARIO), 5. Singh AK, et al. Matching-Adjusted Indirect Comparisons (MAIC) of Safety Between Single-Agent Belantamab Mafodotin Versus Selinexor Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM), 9. 11. Time without symptoms or toxicity in patients with recurrent ovarian cancer receiving niraparib maintenance treatment versus placebo: A TWiST analysis of the ENGOT OV16/NOVA trial, 2. This resource may include information that has not been approved by the US Food and Drug Administration. Goodall E, Wood R, Numbere B, et al. POSTER: Exploring Alternative Dosing Regimens of Single-agent Belantamab Mafodotin on Safety and Efficacy in Patients with Relapsed or Refractory Multiple Myeloma: DREAMM-14, 6. POSTER: Pharmacokinetics and Safety Following a Single Oral Dose of Niraparib in Patients with Moderate Hepatic Impairment, 5. GSK3196165 An investigational anti-GM-CSF monoclonal antibody, improves patient reported outcomes in a phase IIB study of patients with rheumatoid arthritis, 2. . Impact of mepolizumab in patients with life-threatening asthma. Amsterdam, Netherlands: TESARO Bio Netherlands BV; 2019. POSTER: Post hoc analysis of objective response rate by mismatch repair protein dimer loss/mutation status in patients with mismatch repair deficient endometrial cancer treated with dostarlimab (IGCS ENCORE), 11. . Welcome to the Merck Medical Portal. 8. 2. LAG3 (CD223) as a cancer immunotherapy target. POSTER: Management of Immune-Related Adverse Events in Patients with Solid Tumors Treated with Dostarlimab in the GARNET Study, 3. 61), 1. NY-ESO-1 based immunotherapy of cancer: current perspectives. 1. GARNET: Preliminary Safety, Efficacy, Pharmacokinetic, and Biomarker Characterization from a Phase 1 Clinical Trial of TSR-042 (Anti-PD-1 Monoclonal Antibody) in Patients with Recurrent/Advanced NSCLC, 4. Pivotal DREAMM-2 Study: Single-Agent Belantamab Mafodotin (Belamaf; GSK2857916) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to Proteasome Inhibitors, Immunomodulatory Agents, and Refractory and/or Intolerant to Anti-CD38 Monoclonal Antibodies (mAbs), Including Subgroups with Renal Impairment (RI) and High-Risk (HR) Cytogenetics, 3. An Open Label, Multicentre, Observational, Real World, Postmarketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients with Chronic Obstructive Pulmonary Disease. CAPTAIN Study: Daily Digital Spirometry and Symptom Data for Once-Daily, Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Asthma. Healthcare Resource Utilization and Costs Associated with COVID-19 Among Hospitalized Patients in the United States A Population Study. For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge. The anti-BCMA antibody-drug conjugate belantamab mafodotin (GSK2857916) drives immunogenic cell death and immune-mediated anti-tumor response, and in combination with an OX40 agonist potentiates in vivo activity. ABSTRACT ONLY: Biomarker correlates of letetresgene autoleucel (lete-cel; GSK3377794) response in patients with advanced myxoid/round cell liposarcoma (MRCLS), 2. Assessment of Peak Inspiratory Flow Rate in Patients With Chronic Obstructive Pulmonary Disease: Impact on Dose Delivery and Relationship With Response to Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy. (Poster No. 2004;199(1):91-98. Differences in Patient Characteristics between Asthma Patients with and without Eosinophil Measurements. Cancer Cell.2019;36(1):100-114. 7. Safety and efficacy of dostarlimab in patients (pts) with recurrent/advanced non-small cell lung cancer (NSCLC), 8. Genes Dev. Umeclidinium/vilanterol (UMEC/VI) compared with tiotropium (TIO) for time-to-first inpatient admission among patients with chronic obstructive pulmonary disease in a managed care population. The necrosome promotes pancreatic oncogenesis via CXCL1 and Mincle-induced immune suppression. Psychometric Properties of the SF-36 Vitality Scale in Patients With Anemia of Chronic Kidney Disease, 2. ag the affected vaccines and place a label on them saying "DO NOT USE." Do not CD96 effectively competes with CD226 for binding to a shared ligand, CD155, to modulate immune responses and promote tumor cell immune evasion. NY-ESO-ImmTAC (immune mobilizing monoclonal TCR against cancer [IMCnyeso]) is a bifunctional soluble high-affinity T-cell receptor (TCR) specific for NY-ESO-1 that also engages the CD3 receptor on T cells. 2018;7(5):e1426519. Preclinical evaluation of a non-depleting, first-in-class humanized IgG4 agonist anti-ICOS antibody, 2. Gupte R, Liu Z, Kraus WL. [Poster No. POSTER: Survival outcomes of patients with multiple myeloma in France: A cohort study using the French National Healthcare database (SNDS), 5. Headline results for a phase 4, 52-week, randomized, double-blind, placebo-controlled study to assess adverse events of special interest (AESI) in adults with active, autoantibody-positive systemic lupus erythematosus (SLE) receiving belimumab, 1. GSK is investigating the activity of two compounds that target protein arginine methyltransferases (PRMTs). Oral presentation. Rothnie KJ, Bancroft T, Bogart M, et al. CAPTAIN Study: Evaluating the Efficacy of Once-Daily, Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI in Inadequately Controlled Asthma Using Change in Asthma Control Questionnaire and the Relationship With Trough FEV1. Temperature excursions and vaccine handling incidents may damage vaccines and can impact vaccine viability. Prescription Patterns Among Newly Diagnosed Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly Churg-Strauss Syndrome): Evidence from a Managed Care Database in the United States. [Poster No. 817; Abstract A4306]. ORAL PRESENTATION: Bone Marrow Fibrosis Changes Do Not Correlate with Efficacy Outcomes in Myelofibrosis: Analysis of More Than 300 JAK Inhibitor-Nave Patients Treated with Momelotinib or Ruxolitinib, 1. Anti-tumor activity of the type I PRMT inhibitor, GSK3368715, synergizes with PRMT5 inhibition through MTAP loss. 3. 2017;130(suppl 1): 1377. POSTER: Poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitor first-line maintenance among patients with newly diagnosed advanced ovarian cancer in a real-world database, 5. Cost-effectiveness evaluation of sotrovimab, a monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in patients at high risk of disease progression. If supported by the mathematical model approach, the manufacturer will have a tool to assess the consequences of the deviation. PMID . 2. Prevalence of asthma and severe asthma in patients affiliated to the Hospital Italiano Medical Care Program in Buenos Aires, Argentina. The PI3K/AKT and phosphatase and tensin homolog (PTEN) pathways are among the most frequently mutated pathways in human cancers. Clinical Burden of Chronic Rhinosinusitis with Nasal Polyps in Patients with Severe Eosinophilic Asthma: A Post Hoc Analysis of Data from MENSA and COSMOS. POSTER: Treatment patterns and time to next treatment among OC patients in a real-life setting in Finland: the OCRWE-Finland study (ASCO Encore), 3. Cho E-Y, Cho J-E, Jang S-H, et al. POSTER: ENGOT-OV44/FIRST Study: A Randomized, Double-Blind, Adaptive, Phase 3 Study of Platinum-Based Chemotherapy (CT) Dostarlimab Followed by Niraparib Dostarlimab Maintenance as First-Line (1L) Treatment of Stage 3 or 4 OC, 2. P1045; Abstract A5050]. 2016;6(4):446-459. 8. ORAL PRESENTATION: Shapiro A, et al. Initiating Mepolizumab. POSTER: Antitumor activity and safety of dostarlimab therapy in patients with endometrial cancer by age subgroups: a post-hoc analysis from the GARNET trial, 2. Change in nasal polyp size as an indicator of treatment response: SYNAPSE trial analysis (Poster No. This information does not take the place of talking with your doctor. Blood. Ismaila A, Haeussler K, Czira A, et al. Input temperature should be greater than 8.4 C or 47.2 F, Input temperature should be less than 1.5 C or 34.7 F, ASCEND-ID: Daprodustat is Non-Inferior to Darbepoetin Alfa in Treating Anemia in Incident Dialysis Patients, ASCEND-TD: A Randomized, Double-Blind, Active-Controlled Study of Daprodustat Administered Three-Times-Weekly in Hemodialysis Patients, Effects of Daprodustat on Hemoglobin and Quality of Life in Patients With CKD: Results of the ASCEND-NHQ Randomized, Double-blind, Placebo-controlled Trial, ASCEND program: efficacy and safety from ASCEND-D and ND, and overall MACE findings, Healthcare Resource Utilization and Costs Over 5 Years for a Systemic Lupus Erythematosus Cohort Newly Diagnosed With Lupus Nephritis: Evidence From a US Administrative Claims Database. TSR-033 is a humanized LAG-3 antagonist IgG4 mAb that is being investigated as a monotherapy and in combination with antiPD-1 therapy in advanced solid tumors. Simply select from the required information below. Cancer Immunol Res. 2018;22(6):527-545. Vaccine Stability Calculator . GlaxoSmithKline. Poster No. Single-Inhaler Triple Therapy Fluticasone Furoate/Umeclidinium/Vilanterol Improves Lung Function and Symptoms Compared With Tiotropium Monotherapy in Patients With Symptomatic Chronic Obstructive Pulmonary Disease at Risk of Exacerbations. Prevalence and Frequency of Eosinophil Testing in Patients with Asthma. Treatment Patterns and Disease Burden of Triple Therapy in Asthma. Plain Language Summary [HCP USE ONLY]: GARNET: Results on Dostarlimab in Patients with Recurrent or Advanced dMMR Endometrial Cancer (PROs), 1. 64), 5. Bogart M, Germain G, Lalibert F, et al. P474; Abstract A3997]. Rapoport AP, Stadtmauer EA, Binder-Scholl GK, et al. Vaccine Temperature Sanofi is a diversified global healthcare leader AREAS OF FOCUS Corporate responsibility at Sanofi LEARN MORE Sanofi US By phone: 800-981-2491 CONTACT US MAT-US-2014105-v5.-10/2021 Last Update: October 2021 [Poster No. Phase 2, Multi Arm Study of Niraparib in Combination With a PD 1 Inhibitor in Patients With Non Small Cell Lung Cancer: JASPER, Bintrafusp Alfa Bifunctional TGF- Trap/Anti-PD-L1 Fusion Protein, Belantamab Mafodotin - Anti-BCMA Immunoconjugate, PRMT5 Inhibitor (GSK3326595) and Type I PRMT Inhibitor (GSK3368715). A phase I study of GSK525762, a selective bromodomain (BRD) and extra terminal protein (BET) inhibitor: results from part 1 of phase I/II open label single agent study in patients with acute myeloid leukemia (AML). 1. 3. POSTER: RSVPreF3 OA Candidate Vaccine Immunogenicity Presentation. 2. Niraparib + Pembrolizumab (Pembro) Versus Placebo + Pembro 1L Maintenance Therapy in Advanced NSCLC: ZEAL-1L Phase III Study, 2. DREAMM-8: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) with Pomalidomide and Dexamethasone (B-Pd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM), 10. The Potential for Reducing Opioid and Analgesic Prescriptions via Herpes Zoster Vaccination, 8. ORAL FEATURED POSTER: Phase 2 OVARIO Study of Niraparib + Bevacizumab Therapy in Advanced Ovarian Cancer Following Front-Line Platinum-Based Chemotherapy With Bevacizumab, 6. A Prospective Evaluation of Tolerability of Niraparib Dosing Based Upon Baseline Body Weight and Platelet Count: Blinded Pooled Interim Safety Data From the PRIMA/ENGOT OV26/GOG 3012 Study, 3. Zhang S, White J, Meeraus W, et al. Rothnie K, Han X, Bengtson L, et al. CD96 is an immune checkpoint that regulates CD8+ T-cell antitumor function. Epidemiology of Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Hypereosinophilic Syndrome (HES) in Germany: A Claims Database Study. The Impact of Comorbidities and Clinical Characteristics on Real-World Mepolizumab Effectiveness in Patients With Severe Asthma: Results From the REALITI-A Study. Characterization of severe asthma patients affiliated to the Hospital Italiano Medical Care Program in Buenos Aires, Argentina. Terrier B, Jayne D, Hellmich B, et al. It is being investigated as monotherapy and in combination with other anticancer agents in various malignancies. POSTER: Real-World Belantamab Mafodotin (Belamaf) Use: A US Retrospective Longitudinal Pharmacy and Medical Open-Source Claims Database Assessment, 1. ASCEND-ID: Daprodustat is Non-Inferior to Darbepoetin Alfa in Treating Anemia in Incident Dialysis Patients, 2. Exacerbation Reduction in Patients Based Upon Baseline Eosinophil Counts and FEV1 Reversibility. P788; Abstract A5626]. Presentation: A First-in-Human Phase I Study of the OX40 Agonist GSK3174998 (GSK998) +/- Pembrolizumab in Patients (Pts) With Selected Advanced Solid Tumors (ENGAGE-1), 2. Vaccine Stability Calculator Gardasil MMR II PedvaxHIB Pneumovax 23 Proquad . Singh AK, et al. 712; Abstract A1827]. Assessment of Peak Inspiratory Flow Rate in Patients With Chronic Obstructive Pulmonary Disease: Impact on Dose Delivery and Relationship With Response to Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy. PO2409, 3. 2. Efficacy and Safety of Mepolizumab in Hypereosinophilic Syndrome: a Phase III, Randomized, Placebo-Controlled Trial. Cobolimab is a humanized TIM-3 antagonist immunoglobulin G4 (IgG4) mAb being investigated as a monotherapy and in combination with dostarlimab and TSR-033 in advanced solid tumors, including melanoma, NSCLC, and colorectal cancer. Is the top shelf of a pharmacy-grade storage unit acceptable for vaccine storage if there is a fan directly above it? GSK3174998 is a humanized immunoglobulin 1 (IgG1) OX40 agonist antibody that can enhance the proliferation and survival of CD4+ and CD8+ T cells and deplete tumor-infiltrating regulatory T cells via antibody-dependent cell cytotoxicity or phagocytosis. Select Share. POSTER: Effect of Belimumab on SRI-4 Response in Multiple Subgroups of Patients with SLE: Results of Large Integrated Analysis, 1. POSTER: Real-world data on dostarlimab in post-platinum mismatch repair deficient (dMMR)/ microsatellite instability high (MSI-H) advanced/recurrent (A/R) endometrial cancer: descriptive analysis of the French cohort Temporary Authorization of Use (ATU), 8. This indicates that the vaccine has experienced a temperature excursion and references this report; b) If the expiration date of the vaccine has changed, clearly indicate the new expiration date on the package; and c) Return the vaccine to your inventory. Asthma Control in Patients With Severe Eosinophilic Asthma Treated With Mepolizumab in Real-Life Settings: The Prospective, REALITI-A Study. Reasons why patients with severe asthma discontinue biologic treatment, Impact of mepolizumab in patients with life-threatening asthma, CAPTAIN Study: Effect of baseline lung function on response to triple therapy in patients with asthma inadequately controlled on inhaled corticosteroid/long-acting 2-agonist therapy, Views of US pulmonologists on the prevalence of uncontrolled asthma, treatment decisions and the role of treatable traits: results from the CHEST Pulse Surveys, CAPTAIN Study: Association of moderate and severe asthma exacerbations with lung function and patient-reported outcomes in a large randomized phase III clinical trial, Prevalence of asthma control and the associated disease burden in US patients with asthma treated with a fixed-dose combination of inhaled corticosteroid and long-acting 2-agonist, Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol compared with tiotropium monotherapy in chronic obstructive pulmonary disease: a post hoc analysis by airflow limitation, Real-world adherence to single-inhaler versus multiple-inhaler triple therapy among patients with chronic obstructive pulmonary disease in a commercially insured US population, Risk of death and chronic obstructive pulmonary disease (COPD) hospitalization with fluticasone furoate-containing therapy: Post hoc subgroup analysis from the SUMMIT trial in patients with COPD and a history of exacerbation, Demographic and clinical characteristics of patients experiencing on-treatment exacerbations, on-treatment death or premature study treatment withdrawal: The IMPACT Trial, Time-dependent risk of cardiovascular events following an exacerbation in patients with COPD: post hoc analysis from the IMPACT trial, Benefitrisk profiles of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI in patients with chronic obstructive pulmonary disease: a Markov model, Genetic variants do not predict acute COPD exacerbations or treatment response to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and its components, Cross-sectional survey to assess chronic obstructive pulmonary disease (COPD) medication use by United States (US) physicians, Cross-sectional survey to assess the burden of nocturnal symptoms in patients with chronic obstructive pulmonary disease (COPD), Medication adherence and COPD-related costs among patients with COPD treated with umeclidinium/vilanterol (UMEC/VI) versus tiotropium (TIO), Umeclidinium/vilanterol (UMEC/VI) compared with tiotropium (TIO) for time-to-first inpatient admission among patients with chronic obstructive pulmonary disease in a managed care population, Impact of umeclidinium/vilanterol (UMEC/VI) versus tiotropium (TIO), fluticasone propionate/salmeterol (FP/SAL), and budesonide/formoterol (B/F) on time-to-first severe exacerbation among patients with chronic obstructive pulmonary disease with high comorbidities and high costs, Assessment of patient interaction with a dry powder inhaler electronic medication monitor and integrated system within the Chronic Obstructive Pulmonary Disease Foundation Patient Powered Research Network, Chronic obstructive pulmonary disease is associated with an increased risk of herpes zoster: a retrospective analysis of a United States claims database from 2013-2018, Real-World Impact of Mepolizumab on the Oral Corticosteroid Freedom Component of Clinical Remission in Severe Eosinophilic Asthma: International, Prospective REALITI-A Study, Real-World Impact of Systemic Corticosteroid (SCS) Exposure on Healthcare Resource Utilization (HRU) due to SCS-Related Complication among Patients with Asthma in the US. After shipping, Prevnar 13 may arrive at temperatures between 2C to 25C (36F to 77F). Asthma control among the treated U.S. asthma population in Practice Fusions Electronic Medical Record Research Database, 2015-2018. Please download the thermostability information for full details. IF TEMPERATURES ARE OUT OF RANGE, TAKE IMMEDIATE ACTION! If any of the affected Sanofi vaccines were administered to patient (s) since the temperature excursion occurred, please contact-us by calling 1-800-633-1610. Waikar SS, et al. POSTER: Treatment Patterns Among Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Receiving Second- and Third-Line Therapy in a Medicare Population, 2. Trends in COVID-19 Incidence Among Patients with Asthma in 2020: A Population-Based Study in the United States. Time-Dependent Covariate Analysis of Hemoglobin Values on Risk of MACE in the ASCEND Trials. Herrera-Restrepo O et al. POSTER: Updated Analysis of the Inducible T Cell Co-Stimulatory Receptor (ICOS) Agonist, GSK3359609 (GSK609), Combination with Pembrolizumab (pembro) in Patients (pts) with Anti-PD-1/L1 Treatment-Nave Head and Neck Squamous Cell Carcinoma (HNSCC), 17. Encore: DREAMM-2: Single-Agent Belantamab Mafodotin (GSK2857916) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and High-Risk (HR) Cytogenetics [Poster not available for viewing due to copyright restrictions], 8. The Relationship Between Overall Survival (OS), Progression-Free Survival (PFS), and Objective Response Rate (ORR) in Immune Checkpoint Inhibitor Clinical Trials of Head and Neck Squamous Cell Carcinoma (HNSCC): A Systematic Review and Meta-analysis, 10. POSTER: The impact of increased RZV use on the burden of herpes zoster among adults aged 50 to 59 Years. Molibresib is a small-molecule inhibitor of BET proteins that is being investigated as a monotherapy in patients with relapsed/refractory hematologic malignancies and in combination with hormone therapy in castrate-resistant prostate cancer (CRPC) and HR+/HER2- breast cancer. You will now be taken from the GSK U.S. Medical Pollard S, Offenberger J, Lee FE-H, et al. The products discussed may have different product labeling in different countries. Patient-reported outcomes (PROs) in the GARNET trial in patients (pts) with advanced or recurrent mismatch repair deficient/microsatelite instability-high (dMMR/MSI-H) endometrial cancer (EC) treated with dostarlimab, 7. GSK3326595, a selective inhibitor of PRMT5, is being investigated as a monotherapy in solid tumors and in combination with other therapies in various hematologic malignancies. With severe asthma discontinue biologic treatment in diverse tumor types with restricted in! 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