Plain Language Summary [HCP USE ONLY]: ENGOT-EN6/GOG-3031/NSGO-RUBY: A phase 3, randomized, double-blind, multicenter study of dostarlimab + carboplatin-paclitaxel versus placebo + carboplatin-paclitaxel in recurrent or primary advanced endometrial cancer (EC), 4. PUBLICATION ONLY: Understanding patient characteristics, treatment patterns, and clinical outcomes for advanced and recurrent endometrial cancer in Alberta, Canada, 17. Epidemiological Modelling to Estimate the Number of US Patients With Multiple Myeloma at Different Lines of Treatment, 2. P474; Abstract A3997]. 1. The phosphoinositide 3-kinase (PI3K)/protein kinase (AKT) signaling pathway plays a major role in regulating cellular process involved in cancer, including proliferation, growth, survival, and migration. 1. ORAL FEATURED POSTER: Efficacy of Niraparib by Timing of Surgery and Residual Disease: A Post-Hoc Analysis of Patients in the PRIMA/ENGOT-OV26/GOG-3012 Study, 5. ORAL PRESENTATION: PRIMA/ENGOT-OV26/GOG-3012 Study: Long-Term Conditional PFS, 1. Hellmich B, Neukirch K, Lukas M, et al. 5. Abstract Publication No. POSTER: Belimumab Disrupts Memory B-cell Trafficking in Patients with SLE, 2. Thompson-Leduc P, Ghaswalla P, Cheng WY, et al. Poster No. Front Immunol. 1. GSKS SCIENTIFIC ACTIVITIES AT IDWEEK 2020, 2. Trumemba Viable Non- viable . 2. First in Human Study with GSK3359609, Inducible T cell Co-stimulator Receptor Agonist in Patients with Advanced, Solid Tumors: Preliminary Results from INDUCE-1, 3. Assessing Efficacy via Indirect Comparison of Single-Agent Belantamab Mafodotin (Belamaf; GSK2857916) in DREAMM-2 Versus STORM or MAMMOTH Studies in Relapsed/Refractory Multiple Myeloma (RRMM), 1. Chaudhuri R, Canonica GW, Bals R, et al. Das M, Zhu C, Kuchroo VK. GSK3196165 An investigational anti-GM-CSF monoclonal antibody, improves patient reported outcomes in a phase IIB study of patients with rheumatoid arthritis, 2. Efficacy of Mepolizumab in Patients with Eosinophilic Granulomatosis with Polyangiitis and a Vasculitic Phenotype. Identifying drivers of patients and physicians preferences for treatments of anemia of chronic kidney disease: a qualitative study. Prevalence of asthma and severe asthma in patients affiliated to the Hospital Italiano Medical Care Program in Buenos Aires, Argentina. Vaccine Stability Calculator . This can . 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 347). P813; Abstract A4302]. POSTER: A subgroup analysis of response rate by patient characteristics in patients with endometrial cancer receiving monotherapy dostarlimab in the GARNET trial, 8. 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. Learn more about the Merck Manuals and our commitment to Global Medical Knowledge. Follow the tasks below to ensure you are properly documenting the excursion. ORAL PRESENTATION: A phase 0 trigger trial of Niraparib in newly-diagnosed glioblastoma patients (Presentation Posted With Permission), 1. 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. Gowrisankar S, et al. 4. 13. Prevalence of asthma and severe asthma in patients affiliated to the Hospital Italiano Medical Care Program in Buenos Aires, Argentina. P0018. Impact of the COVID-19 Pandemic on Asthma Exacerbations in the United States: A Population-Based Study. POSTER: A Phase 1/2, Dose and Schedule Evaluation Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin Administered in Combination with Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma(Presentation Is Not Available Due to Copyright), 3. POSTER: Efficacy of dostarlimab in endometrial cancer by molecular subtype: a post hoc analysis of the GARNET study (ESMO ENCORE), 10. 8. GSK has data within the stability parameters entered. Network Meta-Analysis of the Efficacy of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus Other Triple Therapies for the Treatment of Chronic Obstructive Pulmonary Disease (COPD): A Comparison of Annualized Moderate and Severe Exacerbations. Time-dependent risk of cardiovascular events following an exacerbation in patients with COPD: post hoc analysis from the IMPACT trial. Patient-reported outcomes (PRO) in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial ESMO 2020, 2. Moraes F, Abreu G, Nogueira T, et al. A comprehensive resource for health care providers on vaccine storage and handling recommendations and best practice strategies. POSTER: Efficacy and safety of dostarlimab in patients (pts) with mismatch repair deficient (dMMR) solid tumors: analysis of 2 cohorts in the GARNET study, 10. POSTER: VOCAL (Views of Ovarian Cancer patients-how maintenance therapy Affects their Lives) study: patient preference for treatment formulation and administration (IGCS 2022), 2. Efficacy and Safety of Niraparib in Elderly Patients (Pts) with Advanced Ovarian Cancer (OC): Results from the PRIMA/ENGOT-OV26/GOG-3012 Trial, 4. Asthma control among the treated U.S. asthma population in Practice Fusions Electronic Medical Record Research Database, 2015-2018. 1. For written information on the thermostability of the selected vaccine, please download the PDF below. 1. CAPTAIN Study: Simultaneous Step-up to High Dose Fluticasone Furoate and Addition of Umeclidinium for the Treatment of Inadequately Controlled Asthma. [Poster No. Based on rounding rules, temperatures between 1.5 C and 8.4 C (34.7 F-47.2 F) are within the recommended range for this vaccine. The Sustained OCS-Sparing Effect of Mepolizumab: Results From the Real-World REALITI-A Study at 2 Years. Treatment Patterns and Disease Burden of Triple Therapy in Asthma. Calverley PMA, Celli BR, Crim C, et al. Lee JK, Schleich F, Canonica GW, et al. Nat Med. 14. Presentation with Audio: Voice Recording: A phase 1b/2, open-label study of bintrafusp alfa with chemotherapy in patients with stage IV NSCLC, 1. POSTER: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MB) versus Danazol (DAN) in Symptomatic and Anemia Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor (Encore), 2. Asthma Control in Patients With Severe Eosinophilic Asthma Treated With Mepolizumab in Real-Life Settings: The Prospective, REALITI-A Study. PUBLICATION ONLY: Qualitative Patient Interviews on Symptoms and Impacts in Metastatic Synovial Sarcoma (mSS), 28. Vogelmeier CF, Kerwin EM, Naya IP, et al. SYMPOSIUM: Managing immune-related adverse events with checkpoint inhibitors, 1. 13. Preliminary Safety, Efficacy, and Pharmacokinetic/Pharmacodynamic Characterization from GARNET, a Phase 1/2 Clinical Trial of the Anti PD 1 Monoclonal Antibody, Dostarlimab, in Patients with Recurrent or Advanced MSI H and MSS Endometrial Cancer (EC), For a copy of a poster please call 1-877-475-6448, 1. Real-World Benefits of Mepolizumab in Patients With Severe Asthma and Comorbid GERD or Anxiety/Depression: Post Hoc Analysis of REALITI-A (Poster No. 3. POSTER: Adoption of New First-line Maintenance Strategies Among Patients with Primary Advanced Ovarian Cancer After Food and Drug Administration Approval, 8. This portal is intended to help health care professionals in the United States and its territories find scientifically-balanced information related to Merck products, including clinical data and research developments. 1. DREAMM-2: Belantamab Mafodotin Effect on Disease Symptoms and HR-QoL in Patients With RRMM [Poster not available for viewing due to copyright restrictions], 10. 2015;7(11):1187-1199. Date of excursion Exact temperature & time at (31F/-1C) or colder Time in the range 32F to 35F (0C to 1C) Time in the range 47F to 77F (9C to 25C) Time at 78F/26C or warmer # cycles cumulative totals Please make additional copies of these blank forms if needed . P1440. Patient Experience of Physician-Patient Communication and Delayed or Misdiagnosis in Patients With Eosinophil-Driven Diseases. POSTER: Clinical Outcomes of Myelofibrosis Patients Following Immediate Transition to Momelotinib from Ruxolitinib, 8. PD-L1 is expressed by many tumor types and is linked to poor clinical outcomes in a variety of cancers. How does frailty impact the efficacy, reactogenicity, immunogenicity and safety of the adjuvanted recombinant zoster vaccine? Brett S, Yadavilli S, Seestaller-Wehr L, et al. Use of Mepolizumab among Individuals with Asthma in the U.S. Time-Dependent Covariate Analysis of Hemoglobin Values on Risk of MACE in the ASCEND Trials. Please contact Customer Service by email at vaccineshoppe.svc@sanofi.com or by phone at 1-800-822-2463 between Monday - Friday from 8:30 am - 6:00 pm ET. Slade D, Ray R, Moretz C, et al. 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. You are encouraged to report vaccine adverse reactions to the US Department of Health and Human Services. Demographics and Characteristics of Patients Who Initiate Biologics for Asthma. 5. Mafodotin delivered to BCMA-expressing malignant cells inhibits microtubule polymerization, resulting in immune-independent apoptosis that is accompanied by release of markers of immunogenic cell death (ICD), which may contribute to an adaptive immune response. Prevalence and Frequency of Eosinophil Testing in Patients with Asthma. GSK3359609 is being actively evaluated in a number of clinical trials in solid tumors, including head and neck squamous cell carcinoma and NSCLC either as monotherapy or in combination with currently available immunomodulatory agents and anticancer therapies. POSTER: Progression-free survival (PFS) and overall survival (OS) in advanced/recurrent (AR) mismatch repair deficient/microsatellite instabilityhigh or proficient/stable (dMMR/MSI-H or MMRp/MSS) endometrial cancer (EC) treated with dostarlimab in the GARNET study, 5. Use of Mepolizumab among Individuals with Asthma in the U.S. [Poster No. Cancer Cell.2019;36(1):100-114. POSTER: Lokhandwala et al. Corbridge T, Deb A, Germain G, et al. This site is intended for US Patients or Caregivers. ORAL PRESENTATION: Updated Results from the Momentum Phase 3 Study of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor, 3. Averell CM, Hahn BA, Zografos L, et al. ORAL PRESENTATION: Safety and Clinical Activity of Belantamab Mafodotin With Lenalidomide Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-6 Arm-A Interim Analysis (Encore), 1. 1. Assessment of Asthma Control in Respiratory Specialist Offices in the US. Corrales L, McWhirter SM, Dubensky TW Jr, Gajewski TF. Example of a product to be stored between 2 and 8C with a 2-day temperature excursion, at 34C (on the left), or 10-day temperature excursion (on the right). 3. 1. The Effect of Belimumab on Kidney Outcomes in SLE: Results of a Large Integrated Analysis, 4. Singh AK, 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. PO2409, ASCEND-ID: Daprodustat is non-inferior to darbepoetin alfa in treating anemia in incident dialysis patients. Assessment of Asthma Control in Respiratory Specialist Offices in the US. Sanofi share and ADRs. Epigenetics. 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. Evaluation of Medication Adherence and Rescue Medication Use in Non-Exacerbating COPD Patients Initiating Umeclidinium/Vilanterol or Budesonide/Formoterol as Initial Maintenance Therapy Within a Large US Health Insurer Database. A Retrospective Analysis of Real-World Tumor BRCA (tBRCA) Testing Trends in Ovarian Cancer (OC) Before and After PARP Inhibitor Approvals, 7. PUBLICATION ONLY: A Phase 1/2, Dose and Schedule Evaluation Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin Administered in Combination with Daratumumab, Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma, 1.POSTER: Belantamab Mafodotin in Combination with VRd for the Treatment of Newly Diagnosed Transplant Eligible Multiple Myeloma Patients: results from the phase II, open label, multicenter, GEM-BELA-VRd trial (Presentation Posted With Permission), 2.PUBLICATION ONLY: Phase 2 Study of BeLAntamab Mafodotin as Pre- and Post-Stem Cell Transplant Consolidation and Maintenance (BLAST study) for Multiple Myeloma Patients in First Remission, 1. 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. CAPTAIN: Effects of age as a continuous variable on asthma control. 1. Dawson M, Stein EM, Huntly BJP, et al. Concomitant Administration of Liquid Porcine Circovirus-free Human Rotavirus Vaccine with Routine Pediatric Vaccines, 1. 2. POSTER: Safety and Clinical Activity of Belantamab Mafodotin With Pembrolizumab in Patients With Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-4 Study, 5. Mepolizumab Treatment Leads to Clinical Asthma Remission in Patients with Severe Eosinophilic Asthma: Results from the Real-World REDES Study. Identifying drivers of patients and physicians preferences for treatments of anemia of chronic kidney disease: a qualitative study. 1-888-825-5249, or call the FDA at Sanofi Pasteur 1-800-822-2463 GlaxoSmithKline 1-888-825-5249 Pfizer 1-800-438-1985 Seqirus 1-855-358-8966 AstraZeneca ~Medimmune . Montes de Oca R, Bhattacharya S, Vitali N, et al. Phase 2 study of bintrafusp alfa, a bifunctional fusion protein targeting TGF- and PD-L1, in platinum-experienced advanced cervical cancer (TiP), 12. 6. 14. Singh AK, et al. Mepolizumab Reduces Exacerbations and Improves Health-Related Quality of Life in Patients With Severe Asthma and Nasal Polyps, Sinusitis, or Allergic Rhinitis. GSK3745417 is a synthetic STING agonist that is being investigated as a monotherapy and in combination with pembrolizumab in relapsed/refractory solid tumors. Poster No. GlaxoSmithKline. NY-ESO-1 and LAGE-1a are widely expressed in diverse tumor types with restricted expression in normal tissues. Demographics and Characteristics of Patients Who Initiate Biologics for Asthma. POSTER: Safety and Clinical Activity of Belantamab Mafodotin With Lenalidomide Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-6 Arm-A Interim Analysis (Encore), 5. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against HZ: Interim Results of an Extension Study of Two Clinical Trials, 7. Analysis of Co-Resistance Among Escherichia coli Urine Isolates From Female Outpatients in the United States. Responsibility for patient care resides with the healthcare professional on the basis of his or her professional license, experience, and knowledge of the individual patient. Impact of the COVID-19 Pandemic on Health Care Resource Utilization (HCRU) and Costs in Chronic Obstructive Pulmonary Disease (COPD) in the United States: A Population-Based Study. 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. Please download the thermostability information for full details. 2. ORAL PRESENTATION: Long-term safety and secondary efficacy endpoints in the ENGOT-OV16/NOVA phase III trial of niraparib in recurrent ovarian cancer, 1. 1. Smith SG, Price R, Mollo MR, et al. Poly ADP ribose polymerases (PARPs) are a family of enzymes involved in many functions, including DNA repair, gene expression, cellular signaling, and base excision repairs. 6. Poster No. 2017;276(1):97-111. Poster No. Lu E, et al. J Clin Oncol. 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. POSTER: Kaye KS, Gupta V, Mulgirigama A, et al. [Poster No. Cross-sectional survey to assess chronic obstructive pulmonary disease (COPD) medication use by United States (US) physicians. ag the affected vaccines and place a label on them saying "DO NOT USE." Do not Poster with Audio: Voice Recording: Therapeutic Dose Selection for Belantamab Mafodotin, a BCMA-Targeting Agent, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Application of Population Pharmacokinetics (PopPK) and Exposure-Response Analyses, The Journey Towards Controlled Asthma: Shifting the Treatment Paradigm, Investigating the Role of Eosinophils in Health, Airway Diseases, and Hypereosinophilic Disorders, Current Understanding of Hypereosinophilic Syndrome (HES): A Rare Inflammatory Eosinophilic Disease, Mar 13-16, 2020 | Philadelphia, PA (Cancelled due to COVID-19), Eosinophilic Granulomatosis with Polyangiitis (EGPA): Pathogenesis, Diagnosis, and Management, The Role of Eosinophilic and Their Potential Heterogeneity in Airways Disease, Uncontrolled Asthma: Changing the Patient Experience, SYMPOSIUM: Advances in Targeting of B-cell Maturation Antigen (BCMA) as an Investigational Novel Approach in Multiple Myeloma, 1. ORAL FEATURED POSTER: An Open-Label Phase 2 Study of Dostarlimab (TSR-042), Bevacizumab (bev), and Niraparib Combination in Patients (pts) with Platinum-Resistant Ovarian Cancer (PROC): Cohort A of the OPAL Trial, 7. Fiore. Rescue Medication Use as an Indicator of Symptom Burden in Patients With COPD: A Post Hoc Analysis of the EMAX Trial. ORAL PRESENTATION: Primary Efficacy and Safety of letetresgene autoleucel (lete-cel; GSK3377794) Pilot study in patients with advanced and metastatic myxoid/round cell liposarcoma (MRCLS), 4. Bogart M, Han X, Bengtson L, et al. Comparative Efficacy of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus Other Triple Therapies for the Treatment of Chronic Obstructive Pulmonary Disease (COPD): A Systematic Literature Review and Network Meta-Analysis. Elaborating the Mechanism of PARP Synthetic Lethality in ATM Loss, 2. Hemoglobin Efficacy and Cardiovascular Safety Data from the ASCEND-ND, -D, and -ID Trials. Ismaila A, Haeussler K, Czira A, et al. Enter the TOTAL time above recommended temp for THIS and ALL PRIOR excursions, Enter the TOTAL time below recommended temp for THIS and ALL PRIOR excursions. Encore: DREAMM-1: Patient Perspectives From the First-in-Human Study of Single-Agent Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM) [Publication only], 4. Najafov A, Chen H, Yuan J. Necroptosis and cancer. P787; Abstract A5625]. Impact of Systemic Corticosteroid (SCS) Exposure on SCS-Related Complications Among Patients with Asthma in the US. 2. ORAL PRESENTATION: Non-OS endpoints in oncology: strategies to bridge the gap in value attribution by regulators, payors, oncologists, and patients, 1. PUBLICATION ONLY: Treatment patterns and time to next treatment among patients with OC in a real-life setting in Finland: the OCRWE-Finland study, 14. [Poster No. Predicting Improvements in COPD with Clinically Important Improvements in Patient-Reported Outcomes: A Post Hoc Analysis of the EMAX Trial. [Poster No. Efficacy of Umeclidinium/Vilanterol Versus Umeclidinium or Salmeterol: A Number-Needed-to-Treat Analysis of the EMAX Trial. 12. You will now be taken from the GSK U.S. Medical 805; Abstract A4294]. 3. IF TEMPERATURES ARE OUT OF RANGE, TAKE IMMEDIATE ACTION! POSTER: First real-life data on niraparib maintenance in newly-diagnosed advanced ovarian cancer: a descriptive analysis of the Temporary Authorisation for Use (ATU) cohort, 2. POSTER: Biomarker correlates of letetresgene autoleucel (lete-cel; GSK3377794) response in patients with advanced myxoid/round cell liposarcoma (MRCLS), 2. Comparison of Peak Inspiratory Flow Rate Between Clinical Trial and Real-World Populations. 8. Real World Evidence in Asthma: Pulmonary Function and Asthma Control in Respiratory Specialty Clinics in the US. 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). CAPTAIN Study: Treatable Traits and the Outcome of Treatment with Inhaled Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI Therapies in Patients with Uncontrolled Asthma, a Pre-specified Subgroup Analysis. Trademarks are owned by or licensed to the GSK group of companies. temperature excursion. Affairs portal to a separate website maintained by Plain Language Summary [HCP USE ONLY]: GARNET: Results on Dostarlimab in Patients with Recurrent or Advanced dMMR Endometrial Cancer (PROs), 1. Change in nasal polyp size as an indicator of treatment response: SYNAPSE trial analysis (Poster No. Notify the primary or backup vaccine coordinator immediately if you discover a temperature excursion. Requena, G et al. PLAIN LANGUAGE SUMMARY [HCP USE ONLY]: The DREAMM-2 Study: What Were the Effects of Belantamab Mafodotin in Patients With Multiple Myeloma and Reduced Kidney Function? J Clin Invest. 4. Poster No. Dasgupta, I et al. Poster No. Genes Dev. 1. Poulard C, Corbo L, Le Romancer M. Protein arginine methylation/demethylation and cancer. Extent and Use of ICS-LABA (Maintenance Only and MART) in Routine Clinical Practice and Associated Clinical and Symptom Unmet Need in the US. Treatment Patterns and Disease Burden of Triple Therapy in Asthma. Cancer After Food and Drug Administration Approval, 8 J. Necroptosis and cancer Step-up High... Of a Large Integrated Analysis, 4 the U.S. time-dependent Covariate Analysis of Hemoglobin Values on risk MACE! The Primary or backup vaccine coordinator immediately if you discover a temperature excursion, Celli BR, C... N, et al Asthma Exacerbations in the ENGOT-OV16/NOVA phase III trial of niraparib in recurrent cancer! 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