Immunology

April, 2019

Efficacy and safety of belimumab in patients of black race with systemic lupus erythematosus: results from the EMBRACE study

June, 2019

1. GSK3196165 An investigational anti-GM-CSF monoclonal antibody, improves patient reported outcomes in a phase IIB study of patients with rheumatoid arthritis

2. 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

April, 2019

1. Mapping disease severity and progression of renal involvement in patients with systemic lupus erythematosus

2. Cluster analysis of patients with SLE in the Adelphi Lupus Disease Specific Programme

3. Patient insights of fatigue in systemic lupus erythematosus and content validation of the FACIT-Fatigue

June, 2019

1. Pooled analysis of the real-world effectiveness of belimumab in treatment of systemic lupus erythematosus using multi-country data from the OBSErve studies

2. The PLUTO study: intravenous belimumab in children with systemic lupus erythematosus

3. 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

October, 2018

Preliminary Safety, Efficacy, and PK/PD Characterization from GARNET, a Phase 1 Clinical Trial of the Anti-PD-1 Monoclonal Antibody, TSR-052, in Patients with Recurrent or Advanced MSI-H Endometrial Cancer

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/GOGO3012 Study

Preliminary safety, efficacy, and PK/PD characterization from GARNET, a phase 1 clinical trial of the Anti-PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-H endometrial cancer

October, 2018

1. Preclinical evaluation of a non-depleting, first-in-class humanized IgG4 agonist anti-ICOS antibody

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. Preliminary Safety, Efficacy, and PK/PD Characterization from GARNET, a Phase 1 Clinical Trial of the Anti-PD-1 Monoclonal Antibody, TSR-052, in Patients with Recurrent or Advanced MSI-H Endometrial Cancer

4. 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. 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/GOGO3012 Study

6. A Retrospective Analysis of Real-World Tumor BRCA (tBRCA) Testing Trends in Ovarian Cancer (OC) Before and After PARP Inhibitor Approvals

7. Brain Metastases in Primary Ovarian Cancer: Real-world Data

November, 2018

1. A Phase 1 study of TSR-022, an Anti-TIM-3 monoclonal antibody, in combination with TSR-042 (Anti-PD-1) in patients with colorectal cancer and Post-PD-1 NSCLC and melanoma

June, 2019

1. A Phase 1 study of TSR-022, an Anti-TIM-3 monoclonal antibody, in combination with TSR-042 (Anti-PD-1) in patients with colorectal cancer and Post-PD-1 NSCLC and melanoma

2. A Phase 1 Dose Escalation Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors

3. 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. The anti-tumor efficacy of TIM-3 blockade in a murine model of sarcoma

June, 2019

1. GSK3196165 An investigational anti-GM-CSF monoclonal antibody, improves patient reported outcomes in a phase IIB study of patients with rheumatoid arthritis

2. 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

June, 2019

1. Pooled analysis of the real-world effectiveness of belimumab in treatment of systemic lupus erythematosus using multi-country data from the OBSErve studies

2. The PLUTO study: intravenous belimumab in children with systemic lupus erythematosus

3. 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

June, 2019

1. GSK3196165 An investigational anti-GM-CSF monoclonal antibody, improves patient reported outcomes in a phase IIB study of patients with rheumatoid arthritis

2. 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

June, 2019

1. Pooled analysis of the real-world effectiveness of belimumab in treatment of systemic lupus erythematosus using multi-country data from the OBSErve studies

2. The PLUTO study: intravenous belimumab in children with systemic lupus erythematosus

3. 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

May 2019

1. InforMing the PAthway of COPD Treatment (IMPACT Study)-Single Inhaler Triple Therapy (fluticasone furoate/umeclidinium/vilanterol) versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients with COPD: Results Based on an Analysis of the North American Region

2. InforMing the PAthway of COPD Treatment (The IMPACT Study): Single Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients with COPD: An Analysis Based on Baseline COPD Medication Use

3. Preventing Clinically Important Deterioration (CID) of COPD with Single-inhaler Triple Therapy Fluticasone Furoate/Umeclidinium/Vilanterol: A Prospective Analysis of the IMPACT trial

4. The IMPACT Trial: Single Inhaler Triple Therapy Fluticasone Furoate/Umeclidinium/Vilanterol versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients with COPD: A Pre-Specified Analysis of Safety According to Age

5. The IMPACT Trial: Single Inhaler Triple Therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in Patients with COPD: Results on Cardiovascular Safety

6. The IMPACT Trial: Single Inhaler Triple Therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in Patients with COPD: Results on Rescue Use and Night-time Awakenings

7. COPD Assessment Test (CAT) score is associated with risk of future exacerbation: An analysis from the IMPACT Trial

8. The IMPACT Trial: Single Inhaler Triple Therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in Patients with COPD: Analysis according to smoking status

9. Reduction in the risk of all-cause mortality with fluticasone furoate/umeclidinium/vilanterol compared to umeclidinium/vilanterol in IMPACT including previously missing or censored vital status data

10. Critical error rates with the ELLIPTA inhaler compared with other dry-powder inhalers in patients with COPD: An open-label, low-intervention clinical study

11. Controller adherence and albuterol use among adult patients with asthma on once or twice-daily ICS/LABA therapy using clip-on sensor technology to assess outcomes HO-16-16516

12. Adherence and asthma control in patients using FF/VI with and without using a sensor that monitors adherence HO-16-16516

13. Characteristics of treated asthma patients experiencing exacerbations in a US database

14. Characterisation of exacerbations of severe eosinophilic asthma on mepolizumab compared to placebo

15. Type 2 Biomarkers and Eosinophil Activation in Severe Asthma and the Impact of Mepolizumab

16. The long-term efficacy and safety of mepolizumab in children from 6 to 11 years of age with severe eosinophilic asthma

17. Eligibility for newer biologic therapies in severe asthma, re-analysis of the IDEAL study

18. The pharmacokinetics and relative bioavailability of mepolizumab 100 mg liquid formulation administered subcutaneously to healthy participants

19. Self-administration of Mepolizumab Liquid Using a Single-Use Prefilled Autoinjector

20. Mepolizumab prefilled autoinjector and prefilled syringe real world use: the patient experience

21. Self-administration of Mepolizumab Liquid Using a Single-Use Prefilled Syringe

22. Characterization and Healthcare Resource Use of Patients with Severe Asthma in Brazil

23. Definitions Matter: Asthma control and Health-related quality of life (HRQoL) in patients with severe asthma in Brazil

24. Meta-analysis of Asthma Control in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab

25. Efficacy of Mepolizumab in Patients with Severe Eosinophilic Asthma by Age of Asthma Onset: Meta-analysis of Two Phase III Trials

26. Efficacy of Mepolizumab in Patients with Severe Eosinophilic Asthma and Concomitant Aspirin-Exacerbated Respiratory Disease: Meta-analysis of Two Phase III Trials

27. No Genetic Associations were Identified with Mepolizumab Efficacy In Eosinophilic COPD

28. Real World Impact of Mepolizumab on Asthma Exacerbations: Adherence Matters

29. Burden of Illness Associated with Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly Churg-Strauss Syndrome) in the United States: Evidence from Two Administrative Claims Databases

30. Patterns of Healthcare Resource use and costs for patients with severe asthma-related exacerbations in Brazilian Private System

31. Comparative Efficacy of Umeclidinium/Vilanterol, Umeclidinium and Salmeterol in Symptomatic Patients with Chronic Obstructive Pulmonary Disease Free of Inhaled Corticosteroids: The EMAX Trial

32. Comparative Efficacy of Once-Daily Umeclidinium and Twice-Daily Salmeterol in Symptomatic Patients with Chronic Obstructive Pulmonary Disease Free of Inhaled Corticosteroids: Results From the EMAX Trial

33. Comparative Efficacy of Once-Daily Umeclidinium and Twice-Daily Salmeterol in Symptomatic Patients with Chronic Obstructive Pulmonary Disease Free of Inhaled Corticosteroids: Results From the EMAX Trial

34. Preventing Clinically Important Deterioration with Umeclidinium/Vilanterol versus Bronchodilator Monotherapy in Patients with Chronic Obstructive Pulmonary Disease Free of Inhaled Corticosteroids: A Prospective Analysis of the EMAX Trial

35. Evaluation of Rescue Medication Use and Medication Adherence in Patients Initiating Umeclidinium/Vilanterol or Tiotropium/Olodaterol Within a Large US Health Insurer Database

36. Evaluation of Time-to-First COPD Exacerbation in Patients with COPD Initiating Maintenance Therapy with Inhaled Fixed-Dose Combinations of LAMA/LABA or ICS/LABA Within a Large US Health Insurer Database

37. Evaluation of Time-to-Triple Therapy in Patients with COPD Initiating Maintenance Therapy with Inhaled Fixed-Dose Combinations of LAMA/LABA versus ICS/LABA within a Large US Health Insurer Database

38. Efficacy and Safety of Inhaled Umeclidinium/Vilanterol in COPD According to Level of Airflow Limitation: A Post Hoc Analysis

39. Impact of Smoking Status on Improvements in Lung Function With Umeclidinium/Vilanterol Versus Fluticasone Propionate/Salmeterol in Patients With COPD

40. Mild chronic obstructive pulmonary disease (COPD) and the presence of dyspnea: inferences from the CanCOLD study

October, 2019

1. REF—US-000627 Long-Term Immunological Persistence of the Adjuvanted Recombinant Zoster Vaccine: Clinical Data and Mathematical Modeling

June, 2019

1. REF—US-000628 Reactogenicity Profile of Adjuvanted Recombinant Zoster Vaccine After Dose 2 According to the Intensity of the Same Event Experienced After Dose 1

2. REF—US-000629 Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction

3. REF—US-000630 Impact of Reactogenicity on Quality of Life and Physical Functioning in Adults ≥50 Years Receiving Both Doses of the Adjuvanted Recombinant Zoster Vaccine

4. REF—US-000631 Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region and Geographic Ancestry/Ethnicity: A Post-Hoc Analysis

5. REF—US-000632 Eliciting Preference for Zoster Vaccination in US Adults Aged 50 Years and Older

6. REF—US-000633 Incidence, Complications, and Recurrence of Herpes Zoster in Unvaccinated U.S. Adults ≥50 Years of Age

7. REF—US0000604 Meningococcal Vaccination Among Patients Newly Diagnosed at High-Risk For Meningococcal Disease in the US

November 2-5, 2019

1. Long-Term Safety Assessment of Niraparib in Patients with Recurrent Ovarian Cancer: Results From the ENGOT-OV16/NOVA Trial

2. Niraparib therapy in patients with newly diagnosed advanced ovarian cancer after chemotherapy: PRIMA/ENGOT-OV26/GOG-3012 Study

September 27 – October 1, 2019

1. Niraparib Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer (PRIMA/ENGOT-OV26/GOG-3012)

2. Part 1 of the METEOR-1 study: dose escalation of GSK3326595, a first-in-class protein arginine methyltransferase 5 (PRMT5) inhibitor

September 27 – October 1, 2019

1. Immune-Related Gene Expression Profiling after Neoadjuvant Chemotherapy of Tubo-Ovarian High-Grade Serous Carcinoma (HGSOC)

2. Evaluation of niraparib 200 mg/d as maintenance therapy in recurrent ovarian cancer and associated thrombocytopenia in a real-world US setting

3. Clinical confirmation of higher exposure to niraparib in tumor vs plasma in patients with breast cancer

4. Trial in Progress- DREAMM 4: A Phase I/II single arm open-label study to explore safety and clinical activity of belantamab mafodotin (GSK2857916) administered in combination with pembrolizumab in patients with relapsed/refractory multiple myeloma (RRMM)

5. Epidemiology of Synovial Sarcoma in EU28 countries

6. Safety and tolerability of autologous T cells with enhanced T-cell receptors specific to NY-ESO-1/LAGE-1a (GSK3377794) alone, or in combination with pembrolizumab, in advanced non-small cell lung cancer: a phase 1b/2a randomized pilot study

7. NY-ESO-1 and LAGE1A – an emerging target for cell therapies in solid tumours

8. Pharmacokinetic/ pharmacodynamic (PK/PD) exposure-response characterization of GSK3359609 (GSK609) from INDUCE-1, a phase I open-label study

9. Inducible T cell Co-stimulatory (ICOS) Receptor Agonist, GSK3359609 (GSK609) alone and combination with pembrolizumab (pembro): preliminary results from INDUCE-1 expansion cohorts in Head and Neck Squamous Cell Carcinoma (HNSCC)

10. Trial in progress: A phase I, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumors

November 13-16, 2019

1. Clinical study to evaluate safety and activity of autologous T cells with enhanced NY-ESO-1–specific T-cell receptor (GSK3377794) in HLA-A*02+ previously treated and previously untreated patients with advanced metastatic or unresectable synovial sarcoma as part of a master protocol design (IGNYTE-ESO)

2. NY-ESO-1 TCR T (GSK3377794) –case studies –sarcoma and MRCLS – correlates of predictable response characteristics

3. Phase I trial of NY-ESO-1-specific adoptive T-cell therapy with GSK3377794 in patients with advanced synovial sarcoma: report of Cohorts 2 and 4

November 8-10 2019

1. Review of evidence for predictive value of microsatellite instability/mismatch repair status in response to non–anti–PD-(L)1 therapies in patients with advanced or recurrent endometrial cancer

2. Autologous T cells with NY-ESO-1–specific T-cell receptor (GSK3377794) in HLA-A*02+ previously treated and untreated advanced metastatic/unresectable synovial sarcoma: A master protocol study design (IGNYTE-ESO)

3. Case studies of synovial sarcoma and MRCLS following treatment with NY-ESO-1 TCR T cells (GSK3377794): correlates of predictable response characteristics

4. Phase I trial of NY-ESO-1-specific adoptive T-cell therapy with GSK3377794 in patients with advanced synovial sarcoma: report of Cohorts 2 and 4