MiQuest Oncology | GSK US Medical Affairs

Belantamab mafodotin:

Cancer Target Rationale

B-cell maturation antigen (BCMA), a membrane protein expressed on malignant plasma cells in all patients with multiple myeloma, supports myeloma cell proliferation and survival.^1-4

Overview

Belantamab mafodotin is the first BCMA-targeted antibody-drug conjugate with a humanized anti-BCMA monoclonal antibody (mAb) conjugated to the microtubule inhibitor mafodotin.^2,5
Belantamab mafodotin specifically binds to BCMA and eliminates myeloma cells by a multimodal mechanism. 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. The antibody component of belantamab mafodotin enhances antibody-dependent cellular cytotoxicity and phagocytosis (ADCC/ADCP).^2,5

References:

Tai Y-T, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-1199.
Tai Y-T, Mayes PA, Acharya C, et al. Novel anti-B-cell maturation antigen antibody-drug conjugate (GSK2857916) selectively induces killing of multiple myeloma. Blood. 2014;123(20):3128-3138.
O’Connor BP, Raman VS, Erikson LD, et al. BCMA is essential for the survival of long-lived bone marrow plasma cells. J Exp Med. 2004;199(1):91-98.
Cho S-F, Anderson KC, Tai Y-T. Targeting B-cell maturation antigen (BCMA) in multiple myeloma: potential uses of BCMA-based immunotherapy. Front Immunol. 2018;9:1-15. doi:10.3389/fi mmu.2018.01821.
Montes de Oca R, Bhattacharya S, Vitali N, et al. 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. Presented at: European Hematology Association (EHA) Annual Meeting; June 13-16, 2019; Amsterdam, Netherlands.

Dostarlimab

Cancer Target Rationale

Programmed cell death protein 1 (PD-1) is an immune checkpoint molecule that interacts with the PD-1 ligands PD-L1 and PD-L2 to limit T-cell–mediated immune responses.¹
PD-L1 is expressed by many tumor types and is linked to poor clinical outcomes in a variety of cancers.¹

Overview

Dostarlimab is a humanized anti–PD-1 mAb that binds with high affinity to PD-1 and effectively blocks interactions with PD-L1 and PD-L2.
Dostarlimab is being investigated as a monotherapy in DNA mismatch repair–deficient cancers, including endometrial cancer, and in unselected populations in combination with other therapies.

References:

Dyck L, Mills KHG. Immune checkpoints and their inhibition in cancer and infectious diseases. Eur J Immunol. 2017;47(5):765-779.

ICOS Agonist IgG4 Antibody

Cancer Target Rationale

Activation of inducible T-cell costimulator (ICOS) supports proliferation and functional activity of effector T cells and expands memory T-cell populations, which promote durable anti-tumor responses.¹

Overview

GSK3359609 is an IgG4 ICOS agonist antibody that is designed to enhance T-cell function and enable antitumor responses without depletion of ICOS-expressing cells.^2,3
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.

References:

Amatore F, Gorvel L, Olive D. Inducible Co-Stimulator (ICOS) as a potential therapeutic target for anti-cancer therapy. Expert Opin Ther Targets. 2018;22(4):343-351
Angevin E, Barnette MS, Bauer TM, et al. INDUCE-1: a phase I open-label study of GSK3359609, an ICOS agonist antibody, administered alone and in combination with pembrolizumab in patients with advanced solid tumors. J Clin Oncol. 2017;35(15):suppl TPS3113.
Brett S, Yadavilli S, Seestaller-Wehr L, et al. Nonclinical evaluation of a non-depleting, first-in-class humanized IgG4 agonist anti-ICOS antibody. Poster presented at: The European Society for Medical Oncology Annual Congress; October 19-23, 2018; Munich, Germany: Poster 1840P.

TIM-3 Antagonist Antibody (Cobolimab)

Cancer Target Rationale

T-cell immunoglobulin and mucin domain-3 (TIM-3), is a negative regulatory checkpoint molecule that regulates T-cell exhaustion, dampens the antitumor immune response, and may promote tumor cell migration and invasion.¹

Overview

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.

References:

Das M, Zhu C, Kuchroo VK. Tim-3 and its role in regulating anti-tumor immunity. Immunol Rev. 2017;276(1):97-111.

LAG-3 Antagonist Antibody (TSR-033)

Cancer Target Rationale

Lymphocyte activation gene-3 (LAG-3) negatively regulates T-cell activity and, in combination with PD-1, mediates T-cell exhaustion.¹

Overview

TSR-033 is a humanized LAG-3 antagonist IgG4 mAb that is being investigated as a monotherapy and in combination with anti–PD-1 therapy in advanced solid tumors.

References:

Andrews LP, Marciscano AE, Drake CG, Vignali DAA. LAG3 (CD223) as a cancer immunotherapy target. Immunol Rev. 2017;276(1):80-96.

STING Agonist (GSK3745417)

Cancer Target Rationale

Stimulator of interferon genes (STING) is a key adapter molecule that mediates sensing of cytosolic DNA and activates T-cell–dependent tumor immunity.¹

Overview

GSK3745417 is a synthetic STING agonist that is being investigated as a monotherapy and in combination with pembrolizumab in relapsed/refractory solid tumors.

References:

Corrales L, McWhirter SM, Dubensky TW Jr, Gajewski TF. The host STING pathway at the interface of cancer and immunity. J Clin Invest. 2016;126(7):2404-2411

Bintrafusp Alfa Bifunctional TGF-β “Trap”/Anti-PD-L1 Fusion Protein

Cancer Target Rationale

Overview

Bintrafusp alfa is a bifunctional fusion protein composed of the extracellular domain of the human transforming growth factor β receptor II (TGF-βRII or TGF-β “trap") fused via a flexible linker to the C-terminus of each heavy chain of the IgG1 antibody blocking PD-L1. Bintrafusp alfa is designed to allow for targeting tumor cells via two nonredundant immunostimulatory mechanisms—the TGF-β and PD-L1 pathways.^1,2
It is being investigated as monotherapy and in combination with other anticancer agents in various malignancies.

References:

Knudson KM, Hicks KC, Luo X, Chen J-Q, Schlom J, Gameiro SR. M7824, a novel bifunctional anti-PD-L1/TGF trap fusion protein, promotes anti-tumor efficacy as monotherapy and in combination with vaccine. Oncoimmunology. 2018;7(5):e1426519.
Lan Y, Zhang D, Xu C, et al. Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-ß. Sci Transl Med. 2018;10(424):eaan5488.

OX40 Agonist Antibody (GSK3174998)

Cancer Target Rationale

Tumor necrosis factor receptor superfamily, member 4 (OX40 [CD134]) is expressed by T cells during antigen-specific priming.¹

Overview

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.^1,2
GSK3174998 is being investigated in combination with other anticancer agents in multiple tumor types

References:

Linch SN, McNamara MJ, Redmond WL. OX40 agonists and combination immunotherapy: putting the pedal to the metal. Front Oncol. 2015;5:34
Aspeslagh S, Postel-Vinay S, Rusakiewicz S, Soria JC, Zitvogel L, Marabelle A. Rationale for anti-OX40 cancer immunotherapy. Eur J Cancer. 2016;52:50-66

Belantamab Mafodotin - Anti-BCMA Immunoconjugate

Cancer Target Rationale

Receptor-interacting serine/threonine-protein kinase 1 (RIPK1) is involved in driving necroptosis, a proinflammatory form of cell death that may promote metastasis and suppress T-cell–driven antitumor immunity.^1,2

Overview

GSK3145095 is a small-molecule RIPK1 inhibitor.

References:

Najafov A, Chen H, Yuan J. Necroptosis and cancer. Trends Cancer. 2017;3(4):294-301.
Seifert L, Werba G, Tiwari S, et al. The necrosome promotes pancreatic oncogenesis via CXCL1 and Mincle-induced immune suppression. Nature. 2016;532(7598):245-249.

NY-ESO-ImmTAC (IMCnyeso)

Cancer Target Rationale

New York esophageal squamous cell carcinoma 1 (NY-ESO-1) and cancer-testis antigen 2 (LAGE-1a) are immunogenic cancer-testis antigens that can elicit humoral and cellular immune responses in cancer patients.^1,2
NY-ESO-1 and LAGE-1a are widely expressed in diverse tumor types with restricted expression in normal tissues.¹

Overview

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.³
It is being studied as a monotherapy in advanced NY-ESO-1– and/or LAGE-1a–positive cancers.

References:

Thomas R, Al-Khadairi G, Roelands J, et al. NY-ESO-1 based immunotherapy of cancer: current perspectives. Front Immunol. 2018;9:947.
Rapoport AP, Stadtmauer EA, Binder-Scholl GK, et al. NY-ESO-1–specific TCR–engineered T cells mediate sustained antigen-specific antitumor effects in myeloma. Nat Med. 2015;21(8):914-921.
McCormack E, Adams KJ, Hassan NJ, et al. Bi-specific TCR-anti CD3 redirected T-cell targeting of NY-ESO-1- and LAGE-1-positive tumors. Cancer Immunol Immunother. 2013;62(4):773-785.

Anti-CD96 Antibody (GSK6097608)

Cancer Target Rationale

CD96 is an immune checkpoint protein expressed on T cells and natural killer (NK) cells in multiple tumor types.^1,2,3
CD96 effectively competes with CD226 for binding to a shared ligand, CD155, to modulate immune responses and promote tumor cell immune evasion.^1,2,3

Overview

GSK6097608 inhibits the binding of CD96 to CD155 and activates T cells and NK cells, which enhances antitumor activity.^1,3
GSK6097608 is a first-in-class anti-CD96 IgG1 monoclonal antibody being investigated as a monotherapy and in combination with dostarlimab (anti-PD1 antibody) in advanced solid tumors.⁴

References:

Blake SJ, Stannard K, Liu J, et al. Suppression of metastases using a new lymphocyte checkpoint target for cancer immunotherapy. Cancer Discov. 2016;6(4):446-459.
Georgiev H, Ravens I, Papadogianni G, Bernhardt G. Coming of age: CD96 emerges as modulator of immune responses. Front Immunol. 2018;9:1072. doi:10.3389/fimmu.2018.01072.
Mittal D, Lepletier A, Madore J, et al. CD96 is an immune checkpoint that regulates CD8+ T-cell antitumor function. Cancer Immunol Res. 2019;7(4):559-571.
ClinicalTrials.gov. https://clinicaltrials.gov/. Accessed July 9, 2020.
^§In collaboration with 23andMe

Molibresib BET Inhibitor

Cancer Target Rationale

Bromodomain and extraterminal (BET) proteins bind to acetylated lysines in histone tails and other nuclear proteins to regulate the epigenetic landscape.¹
They directly regulate expression of many cancer-related genes, including c-MYC.¹

Overview

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.²

References:

Pérez-Salvia M, Esteller M. Bromodomain inhibitors and cancer therapy: from structures to applications. Epigenetics. 2017;12(5):323-339.
Dawson M, Stein EM, Huntly BJP, et al. 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). Blood. 2017;130(suppl 1): 1377.

PRMT5 Inhibitor (GSK3326595) and Type I PRMT Inhibitor (GSK3368715)

Cancer Target Rationale

GSK is investigating the activity of two compounds that target protein arginine methyltransferases (PRMTs).
PRMT5 is overexpressed in multiple tumor types, including lymphoma and breast, lung, and bladder cancer, and regulates splicing, gene expression, and activation of p53.^1,2

Overview

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.
GSK3368715, a type 1 PRMT inhibitor, is being investigated in phase I trials for patients with diffuse large B-cell lymphoma and solid tumors.³

References:

Smith E, Zhou W, Shindiapina P, Sif S, Li C, Baiocchi RA. Recent advances in targeting protein arginine methyltransferase enzymes in cancer therapy. Expert Opin Ther Targets. 2018;22(6):527-545.
Poulard C, Corbo L, Le Romancer M. Protein arginine methylation/demethylation and cancer. Oncotarget. 2016;7(41):67532-67550.
Fedoriw A, Rajapurkar SR, O’Brien S, et al. Anti-tumor activity of the type I PRMT inhibitor, GSK3368715, synergizes with PRMT5 inhibition through MTAP loss. Cancer Cell.2019;36(1):100-114.

PI3Kβ Inhibitor (GSK2636771)

Cancer Target Rationale

The phosphoinositide 3-kinase (PI3K)/protein kinase ß (AKT) signaling pathway plays a major role in regulating cellular process involved in cancer, including proliferation, growth, survival, and migration.^1,2
The PI3K/AKT and phosphatase and tensin homolog (PTEN) pathways are among the most frequently mutated pathways in human cancers.²

Overview

GSK is investigating a PI3Kß inhibitor, GSK2636771, in combination with enzalutamide, in PTEN-deficient metastatic castration-resistant prostate cancer (mCRPC).

References:

Faes S, Dormond O. PI3K and AKT: unfaithful partners in cancer. Int J Mol Sci. 2015;16(9):21138-21152.
Stark A-K, Sriskantharjah S, Hessel EM, Okkenhaug K. PI3K inhibitors in inflammation, autoimmunity and cancer. Curr Opin Pharmacol. 2015;23:82-91.

Niraparib (PARP Inhibitor)

Cancer Target Rationale

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.¹
PARP inhibition induces cell death through synthetic lethality.¹

Overview

Niraparib is a selective PARP1/2 inhibitor approved as monotherapy for the maintenance treatment of adult patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.^2,3
Niraparib is being investigated as a monotherapy and in combination with other anticancer agents, including dostarlimab, in breast cancer, ovarian cancer, and advanced NSCLC.

References:

Gupte R, Liu Z, Kraus WL. PARPs and ADP-ribosylation: recent advances linking molecular functions to biological outcomes. Genes Dev. 2017;31(2):101-1261. Gupte R, Liu Z, Kraus WL. PARPs and ADP-ribosylation: recent advances linking molecular functions to biological outcomes. Genes Dev. 2017;31(2):101-126.
Zejula [summary of product characteristics]. Amsterdam, Netherlands: TESARO Bio Netherlands BV; 2019.
ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2019.

Posters

GSK Sponsored Studies

September 9-13, 2022 | Paris, France

1. POSTER: Treatment patterns, outcomes, and physician decision making in multiple myeloma: a real-world European study

2. POSTER: Frequency and impact of retreatment in relapsed refractory multiple myeloma (RRMM): Real-world survey conducted in 5 European Countries (United Kingdom, France, Germany, Italy, Spain)

3. POSTER: Updated PFS and Safety by Investigator Assessment (IA) from PRIMA/ENGOT-OV26/GOG-3012 Study

4. POSTER: Progression-free survival (PFS) and overall survival (OS) in advanced/recurrent (AR) mismatch repair deficient/microsatellite instability–high or proficient/stable (dMMR/MSI-H or MMRp/MSS) endometrial cancer (EC) treated with dostarlimab in the GARNET study

5. POSTER: Efficacy of dostarlimab in endometrial cancer (EC) by molecular subtype: A post hoc analysis of the GARNET study

6. POSTER: Progression-free survival (PFS) and overall survival (OS) in patients (pts) with mismatch repair deficient (dMMR) solid tumors treated with dostarlimab in the GARNET study

7. 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. POSTER: Phase 2 study of anti-TIGIT GSK4428859A (GSK’859A)/EOS-448 + anti-CD96 GSK6097608 (GSK’608) + anti–PD-1 dostarlimab in non-small cell lung cancer (NSCLC)

Supported Collaborative Studies

1.POSTER: Prevalence and clinical characteristics of metastatic synovial sarcoma (mSS) patients with tumours expressing NY-ESO-1 antigen (NY+) and who are HLA-A*02:01, *02:05 or *02:06 allele positive (HLA+): Cohort study from the French Sarcoma Group

Investigator Sponsored Studies

1.POSTER: NIRVANA-1: A multicentric randomized trial to compare carboplatin-paclitaxel (CP) followed by niraparib (nira) to CP–bevacizumab (bev) followed by nira-bev in patients with stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery (Presentation Not Available)

Oral Presentations

August 25-27, 2022 | Los Angeles, CA

1. ORAL PRESENTATION: Impact of baseline ocular conditions (BOCs) on belantamab mafodotin (belamaf)-related corneal events in patients (pts) with relapsed or refractory multiple myeloma (RRMM)

Oral Presentations

June 3-7, 2022 | Chicago, IL | Virtual

1. ORAL PRESENTATION: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MB) versus Danazol (DAN) in Symptomatic and Anemia Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor

2. ORAL PRESENTATION: Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER)

3. 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. ORAL PRESENTATION: Dostarlimab in advanced/recurrent (AR) mismatch repair deficient/microsatellite instability–high or proficient/stable (dMMR/MSI-H or MMRp/MSS) endometrial cancer (EC): the GARNET study

European League Against Rheumatism (EULAR)

Oral Presentations

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

European League Against Rheumatism (EULAR)

Oral Presentations

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

European League Against Rheumatism (EULAR)

Oral Presentations

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

ATS 2022

POSTERS BY GSK ASSOCIATED WITH NUCALA:

Severe Eosinophilic Asthma

1. Chupp G, Heaney LG, Pelaia G, et al. The Impact of Comorbidities and Clinical Characteristics on Real-World Mepolizumab Effectiveness in Patients With Severe Asthma: Results From the REALITI-A Study.

2. Corbridge T, Deb A, Germain G, et al. Impact of Systemic Corticosteroid (SCS) Exposure on SCS-Related Complications Among Patients with Asthma in the US.

3. Corbridge T, Deb A, Packnett E, et al. Prevalence and Frequency of Eosinophil Testing in Patients with Asthma.

4. Domingo Ribas C, Pavord I, Price R, et al. Mepolizumab Treatment Leads to Clinical Asthma Remission in Patients with Severe Eosinophilic Asthma: Results from the Real-World REDES Study.

5. Lee JK, Schleich F, Canonica GW, et al. National Differences in Real-World Outcomes with Mepolizumab Treatment for Patients with Severe Asthma: Results from the REALITI-A Study.

6. Lu E, Mu G, Alfonso-Cristancho R. Demographics and Characteristics of Patients Who Initiate Biologics for Asthma.

Nasal Polyps

1. Hwee J, Smith S, Small M, et al. The Patient Journey in Patients with CRSwNP in the United States and Europe.

2. Liu M, Bagnasco D, Matucci A, et al. The Impact of Comorbid Nasal Polyps on Real-World Mepolizumab Effectiveness in Patients with Severe Asthma: Results from the REALITI-A Study.

3. Smith SG, Price R, Mollo MR, et al. Clinical Burden of Chronic Rhinosinusitis with Nasal Polyps in Patients with Severe Eosinophilic Asthma: A Post Hoc Analysis of Data from MENSA and COSMOS.

POSTERS BY GSK ASSOCIATED WITH TRELEGY:

American Thoracic Society (ATS)

Posters & Oral Presentations

Severe Eosinophilic Asthma

1. Chaudhuri R, Canonica GW, Bals R, et al. Asthma Control in Patients With Severe Eosinophilic Asthma Treated With Mepolizumab in Real-Life Settings: The Prospective, REALITI-A Study. [Poster No. 714; Abstract A4267].

2. Hahn B, Bogart M, Silver J, et al. Changes in Oral Corticosteroid (OCS) Use Following Initiation of Mepolizumab Therapy in Patients with Asthma. [Poster No. 804; Abstract A7741].

3. Molfino NA, Averell CM, Hahn BA, et al. Patients with Uncontrolled Asthma Eligible for a Biologic. [Poster No. 801; Abstract A7738].

4. Moore WC, Kornmann O, Humbert M, et al. Outcomes Following Continuation or Stopping Long-Term Mepolizumab Treatment in Patients With Severe Eosinophilic Asthma: The Randomized COMET Trial. [Oral presentation available here; Abstract A4211].

5. Moraes F, Abreu G, Nogueira T, et al. Characterization of severe asthma patients affiliated to the Hospital Italiano Medical Care Program in Buenos Aires, Argentina. [Poster No. 712; Abstract A1827].

6. Moraes F, Abreu G, Nogueira T, et al. Prevalence of asthma and severe asthma in patients affiliated to the Hospital Italiano Medical Care Program in Buenos Aires, Argentina. [Poster No. 710; Abstract A1825].

7. Verhamme K, de Ridder M, Webb D, et al. Differences in Patient Characteristics between Asthma Patients with and without Eosinophil Measurements. [Poster No. P792; Abstract A5630].

8. Wu AC, McMahon PM, Mendelsohn A, et al. Use of Mepolizumab among Individuals with Asthma in the U.S. [Poster No. P742; Abstract A4771].

Self-Administration Formulation of Mepolizumab

1. Prazma C, Bernstein D, Brightling C, et al. The Severe Asthma Patient Experience: In-Clinic and Self-Administration of Mepolizumab. [Poster No. 1301; Abstract A1312].

Eosinophilic Granulomatosis with Polyangiitis

1. Bell CF, Blauer-Peterson C. 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. P1286; Abstract A6579].

Hypereosinophilic Syndrome

1. Steinfeld J, Roufosse F, Kahn JE, et al. Efficacy and Safety of Mepolizumab in Hypereosinophilic Syndrome: a Phase III, Randomized, Placebo-Controlled Trial. [Oral presentation available here; Abstract A4212].

Asthma

1. Averell CM, Hahn BA, Zografos L, et al. Assessment of Asthma Control in Respiratory Specialist Offices in the US. [Poster No. P711; Abstract A1826].

2. Bogart M, Chastek B, White J, et al. Treatment Patterns and Disease Burden of Triple Therapy in Asthma. [Poster No. P805; Abstract A7742].

3. Davitte J, DeBarmore B, Hinds D, et al. Asthma control among the treated U.S. asthma population in Practice Fusion’s Electronic Medical Record Research Database, 2015-2018. [Poster No. P699; Abstract A1814].

4. Fowler A, Kerstjens HAM, Bailes Z, 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. [Poster No. P788; Abstract A5626].

5. Kerstjens HA, Pavord ID, Peachey G, et al. CAPTAIN Study: Simultaneous Step-up to High Dose Fluticasone Furoate and Addition of Umeclidinium for the Treatment of Inadequately Controlled Asthma. [Oral presentation available here; Abstract A4209].

6. Lee LA, Boulet LP, Fowler A, et al. CAPTAIN Study: Daily Digital Spirometry and Symptom Data for Once-Daily, Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Asthma. [Poster No. P787; Abstract A5625].

7. Molfino NA, Averell CM, Hahn BA, et al. Real World Evidence in Asthma: Pulmonary Function and Asthma Control in Respiratory Specialty Clinics in the US. [Poster No. P372; Abstract A6482]

8. Pavord ID, Fowler A, Kerstjens HA, et al. 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. [Oral presentation available here; Abstract A6247].

9. Sansbury LB, Hinds D, Chao J, et al. Treatment sequencing among asthma patients who were newly treated with long-acting antimuscarinic antagonist (LAMA) in the United States. [Poster No. P713; Abstract A1828]

10. Tabberer M, von Maltzahn R, Bacci E, et al. Evaluation of the Psychometric Properties, Scoring Algorithm, and Score Interpretation of the E-RS®: Asthma in Two Clinical Trials of Moderate to Severe Asthma. [Poster No. P786; Abstract A5624]

COPD

1. Anderson M, Drummond MB, Jain R, et al. 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. P813; Abstract A4302].

2. Ferguson GT, Brown N, Compton C, et al. Once-Daily Single-Inhaler Versus Twice-Daily Multiple-Inhaler Triple Therapy: Two Replicate Trials in Patients With Chronic Obstructive Pulmonary Disease (COPD). [Poster No. P806; Abstract A4295].

3. Halpin DMG, Worsley S, Ismaila AS, et al. INTREPID: Clinical Effectiveness of Once-Daily Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol Versus Multiple-Inhaler Triple Therapy in Usual Clinical Practice. [Poster No. P824; Abstract A4313].

4. Mularski R, Wu B, Fuoco MJ, et al. Continuity of Care Assessment Within a Vertically Integrated Care Management Organization Before and After COPD-related Exacerbations. [Poster No. P276; Abstract A4811].

5. Mularski RA, Drummond MB, Jain R, et al. Comparison of Peak Inspiratory Flow Rate Between Clinical Trial and Real-World Populations. [Poster No. P1045; Abstract A5050].

6. Obeid D, Bansal S, Brown N, et al. 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. [Poster No. 805; Abstract A4294].

7. Bjermer L, Maltais F, Vogelmeier CF, et al. Efficacy of Umeclidinium/Vilanterol Versus Umeclidinium or Salmeterol: A Number-Needed-to-Treat Analysis of the EMAX Trial. [Poster No. P1091; Abstract A3326].

8. Cole AL, Moretz C, Mu G, et al. 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. [Poster No. 817; Abstract A4306].

9. Kerwin EM, Maltais F, Boucot IH, et al. Analysis of a Composite Endpoint of Exacerbation and Early Study Treatment Withdrawal in Symptomatic Patients With COPD Free of Inhaled Corticosteroids: A Post Hoc Analysis of the EMAX Trial. [Poster No. 518; Abstract A4579].

10. Kerwin EM, Bjermer L, Maltais F, et al. Rescue Medication Use as an Indicator of Symptom Burden in Patients With COPD: A Post Hoc Analysis of the EMAX Trial. [Poster No. 1089; Abstract A3324].

11. Moretz C, Hahn B, White J, et al. Symptom Burden in Medicare Advantage Patients with COPD Initiating Umeclidinium/Vilanterol or Fluticasone Propionate/Salmeterol Therapy. [Poster No. 811; Abstract A4300].

12. Vogelmeier CF, Kerwin EM, Naya IP, et al. Predicting Improvements in COPD with Clinically Important Improvements in Patient-Reported Outcomes: A Post Hoc Analysis of the EMAX Trial. [Poster No. 1053; Abstract A5058].

13. Vogelmeier CF, Boucot IH, Kerwin EM, et al. Improvements in COPD Symptoms With Umeclidinium/Vilanterol Analyzed by Baseline CAT Score: A Post Hoc Analysis of the EMAX Trial. [Poster No. 1090; Abstract A3325].

14. Keir HR, Richardson H, Mayhew D, et al. Neutrophil extracellular traps and CXCR2 antagonism in chronic obstructive pulmonary disease: A pilot randomized control study. [Poster No. P474; Abstract A3997].

AAAAI

Oral Presentations

1. Once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI in inadequately controlled asthma: the CAPTAIN study

AAAAI

Posters

1. Exacerbation Reduction in Patients Based Upon Baseline Eosinophil Counts and FEV1 Reversibility

2. Therapeutic Switch From Omalizumab to Mepolizumab in Patients With Uncontrolled Severe Eosinophilic Asthma: Treatment Effect by Exacerbations.

3. Therapeutic Switch From Omalizumab to Mepolizumab in Patients With Uncontrolled Severe Eosinophilic Asthma: Treatment Effect by ACQ and SGRQ Quartiles

4. Practical Use of ELLIPTA, a Once-Daily, Dry Powder Inhaler for Children With Asthma

5. Nasal Polyp Symptoms: How Well Do Physicians Know Their Patients?

6. Seasonal Efficacy of Mepolizumab in Patients With Severe Eosinophilic Asthma – Meta-analysis From Two Phase 3 Trials.

7. Mepolizumab Reduces Exacerbations and Improves Health-Related Quality of Life in Patients With Severe Asthma and Nasal Polyps, Sinusitis, or Allergic Rhinitis.

8. Efficacy of Mepolizumab Stratified by Baseline Blood Eosinophil Count

9. Step-up to High Dose Fluticasone Furoate in Combination With Long-Acting Bronchodilator in Inadequately Controlled Asthma: The CAPTAIN Study

American College of Chest Physicians (CHEST)

Posters

Severe Eosinophilic Asthma

1. Silver J, Bogart M, Molfino N, et al. Reasons why patients with severe asthma discontinue biologic treatment. Poster No. P0018.

2. Silver J, Bogart M, Molfino N, et al. Impact of mepolizumab in patients with life-threatening asthma. Poster No. P0017.

Asthma

1. Nathan R, Boulet L-P, Kerstjens HA, et al. CAPTAIN Study: Effect of baseline lung function on response to triple therapy in patients with asthma inadequately controlled on inhaled corticosteroid/long-acting β2-agonist therapy. Poster No. P1483.

2. Ramesh N, Hegewald M, Maselli DJ, et al. Views of US pulmonologists on the prevalence of uncontrolled asthma, treatment decisions and the role of treatable traits: results from the CHEST Pulse Surveys. Poster No. P1488.

3. Sule N, Fowler A, Kerstjens HA, et al. CAPTAIN Study: Association of moderate and severe asthma exacerbations with lung function and patient-reported outcomes in a large randomized phase III clinical trial. Oral presentation.

4. Zhang S, White J, Meeraus W, et al. 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 β2-agonist. Poster No. P1512.

COPD

1. Anzueto A, Obeid D, Bansal S, et al. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol compared with tiotropium monotherapy in chronic obstructive pulmonary disease: a post hoc analysis by airflow limitation. Poster No. P1440.

2. Bogart M, Wu B, Germain G, et al. Real-world adherence to single-inhaler versus multiple-inhaler triple therapy among patients with chronic obstructive pulmonary disease in a commercially insured US population. Poster No. P1444.

3. Calverley PMA, Celli BR, Crim C, et al. 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. Poster No. P1448.

4. Criner GJ, Barnes N, Brusselle G, et al. Demographic and clinical characteristics of patients experiencing on-treatment exacerbations, on-treatment death or premature study treatment withdrawal: The IMPACT Trial. Poster No. P1454.

5. Dransfield MT, Halpin DMG, Han MK, et al. Time-dependent risk of cardiovascular events following an exacerbation in patients with COPD: post hoc analysis from the IMPACT trial. Poster No. P1458.

6. Han MK, Bratton DJ, Hartley B, et al. Benefit–risk profiles of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI in patients with chronic obstructive pulmonary disease: a Markov model. Oral presentation.

7. Hosking L, Yeo A, Hoffman J, et al. Genetic variants do not predict acute COPD exacerbations or treatment response to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and its components. Poster No. P1501.

8. Mannino D, Siddall J, Small M, et al. Cross-sectional survey to assess chronic obstructive pulmonary disease (COPD) medication use by United States (US) physicians. Poster No. P1446.

9. Soler X, Siddall J, Small M, et al. Cross-sectional survey to assess the burden of nocturnal symptoms in patients with chronic obstructive pulmonary disease (COPD). Poster No. P1445.

10. Slade D, Ray R, Moretz C, et al. Medication adherence and COPD-related costs among patients with COPD treated with umeclidinium/vilanterol (UMEC/VI) versus tiotropium (TIO). Poster No. 1467.

11. Slade D, Ray R, Moretz C, et al. 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. Poster No. 1465.

12. Slade D, Ray R, Moretz C, et al. 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. Poster No. 1466.

13. McCreary G, Yawn BP, Linnell J, et al. 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. Poster No. P1481.

14. Thompson-Leduc P, Ghaswalla P, Cheng WY, et al. 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. Poster No. P1505.

AAAAI

Oral Presentation

Mar 13-16, 2020

1. Once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI in inadequately controlled asthma: the CAPTAIN study

Posters

Mar 13-16, 2020

1. Exacerbation Reduction in Patients Based Upon Baseline Eosinophil Counts and FEV1 Reversibility

2. Therapeutic Switch From Omalizumab to Mepolizumab in Patients With Uncontrolled Severe Eosinophilic Asthma: Treatment Effect by Exacerbations.

3. Therapeutic Switch From Omalizumab to Mepolizumab in Patients With Uncontrolled Severe Eosinophilic Asthma: Treatment Effect by ACQ and SGRQ Quartiles.

4. Practical Use of ELLIPTA, a Once-Daily, Dry Powder Inhaler for Children With Asthma

5. Nasal Polyp Symptoms: How Well Do Physicians Know Their Patients?

6. Seasonal Efficacy of Mepolizumab in Patients With Severe Eosinophilic Asthma – Meta-analysis From Two Phase 3 Trials.

7. Mepolizumab Reduces Exacerbations and Improves Health-Related Quality of Life in Patients With Severe Asthma and Nasal Polyps, Sinusitis, or Allergic Rhinitis.

8. Efficacy of Mepolizumab Stratified by Baseline Blood Eosinophil Count

9. Step-up to High Dose Fluticasone Furoate in Combination With Long-Acting Bronchodilator in Inadequately Controlled Asthma: The CAPTAIN Study

AAAAI 2022

POSTERS BY GSK ON NUCALA:

Severe Eosinophilic Asthma

1. Chupp G, Lee JK, Liu MC, et al. Mepolizumab Demonstrates Real-World Clinical Effectiveness in Both Type 2 Biomarker High and Type 2 Biomarker Low Patients With Severe Asthma.[Abstract/Poster No. L81].

2. Bernstein D, Liu MC, Schleich F, et al. The Impact of Baseline Exhaled Nitric Oxide Levels and Blood Eosinophil Count on Clinical Outcomes in REALITI-A.[Abstract/Poster No. P570].

3. Lee JK, Pollard S, Liu MC, et al. Influence of Baseline Total IgE and History of Previous Omalizumab Use on the Impact of Mepolizumab in Reducing Rate of Severe Asthma Exacerbations: Results From the Real-World REALITI-A Study. [Abstract/Poster No. P574].

4. Liu MC, Schleich F, Lee JK, et al. The Clinical Benefit of Mepolizumab Treatment Is Independent of Baseline Maintenance Oral Corticosteroid Use: Results From the Real-World REALITI-A Study. [Abstract/Presentation No. P443].

Eosinophilic Granulomatosis With Polyangiitis

1. Khoury P, Akuthota P, Baylis L, et al. Impact of Baseline Treatment, Duration of Disease, and Refractory Status on Outcomes in Mepolizumab-Treated Patients With EGPA. [Abstract/Poster No. P154].

Nasal Polyps

1. Mullol J, Lund V, Wagenmann M, et al. Mepolizumab Induced Loss of Smell Improvement in Patients With Chronic Rhinosinusitis With Nasal Polyps From the SYNAPSE Study. [Abstract/Poster No. P481].

PRESENTATIONS BY GSK ON TRELEGY IN ASTHMA:

1. Germain G, Settipane RA, Abbott C, et al. Patient Characteristics and Treatment Patterns of Elderly Asthma Patients Initiating FF/UMEC/VI. [Abstract/Poster No. P275].

ACAAI 2021

Posters

EGPA

1. Wechsler ME, et al. Oral Corticosteroid–Sparing Effect of Mepolizumab in Patients With Eosinophilic Granulomatosis With Polyangiitis. Presented at ACAAI 2021

Trelegy

1. Oppenheimer J, et al. CAPTAIN study: Effects of baseline IgE levels on triple therapy response in inadequately controlled asthma. Presented at ACAAI 2021

CHEST 2021

Posters

SEA

1. Lugogo N, et al. Mepolizumab Reduces Exacerbations, OCS and Cost Among Patients with Severe Asthma and the Highest Expenditures Prior to Treatment.Presented at CHEST 2021.

Trelegy in COPD

1. Panettieri R, et al. Effect of once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol triple therapy on exacerbations compared with budesonide/formoterol dual therapy in patients with chronic obstructive pulmonary disease and no history of exacerbations: a post hoc analysis of the FULFIL study.

2. Panettieri R, et al. Effect of once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol triple therapy on severe exacerbation rates compared with twice-daily budesonide/formoterol dual therapy in patients with chronic obstructive pulmonary disease: a post hoc analysis of the FULFIL study. Presented at CHEST 2021.

3. McCreary G, et al. The Patient’s Journey Through COPD Treatment. Presented at CHEST 2021.

4. Bogart M, et al. Burden of systemic corticosteroid utilization in COPD.Presented at CHEST 2021.

5. Bogart M, et al. Changes in Oral Corticosteroid Utilization in Patients with COPD Following Initiation of FF/UMEC/VI.Presented at CHEST 2021.

6. Bogart M, et al. COPD Exacerbations in Patients Switched from Multiple-Inhaler Triple Therapy to FF/UMEC/VI.Presented at CHEST 2021.

Trelegy in Asthma

1. Busse W, et al. CAPTAIN: Effects of Baseline SABA Use on Response to Triple Therapy in Patients With Inadequately Controlled Asthma on ICS/LABA.Presented at CHEST 2021.

2. Meeraus W, et al. Discontinuation and Re-initiation of Multiple Inhaler Triple Therapy in Adult Patients With Asthma: A Cohort Study. Presented at CHEST 2021.

3. Lugogo N, et al. CAPTAIN: Effects of age of asthma onset as a continuous variable on treatment outcomes.Presented at CHEST 2021.

4. Hanania NA, et al. CAPTAIN: Effects of age as a continuous variable on treatment outcomes.Presented at CHEST 2021.

5. Neffen H, et al. Is there association and correlation between patient symptom perception and asthma control? A rapid literature review.Presented at CHEST 2021.

AAOA 2021

Oral Presentation

1. Bhattacharyya N, et al. Features Associated with High-Cost Burden Among Patients with Nasal Polyps: A Machine Learning Claims-Based Analysis.

AAO-HNSF 2021

Posters

1. Benson VS, et al. A Real-World Characterization of Nasal Polyp Patient Burden. SP467

2. Benson VS, et al. Blood and Tissue Eosinophil Counts in Recurrent Nasal Polyps Patients. SP469

ARS 2021

Posters

CRSwNP

1. Fokkens WJ, et al. Mepolizumab reduces the need for surgery in patients with chronic rhinosinusitis with nasal polyps.ARS-COSM 2021

AAFP 2021

Posters

Shingrix

1. Fiore. Safety and reactogenicity of RZV: Experience from clinical trials and post-marketing.Poster F\AAFP 2021

Oral Presentations

Oct 21-25, 2020

1. GSK’S SCIENTIFIC ACTIVITIES AT IDWEEK^™ 2020

2. Individual and State-Level Factors Associated with Receipt of Multiple Recommended Adolescent Vaccines in the US

3. Impact of State Residence on Adult Vaccination Uptake: A Multilevel Modeling Approach

4. How does frailty impact the efficacy, reactogenicity, immunogenicity and safety of the adjuvanted recombinant zoster vaccine?

5. Can Recombinant Zoster Vaccine Administration Decrease the Use of HZ-Related Pain Medication Across Randomized Controlled Studies?

6. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against HZ: Interim Results of an Extension Study of Two Clinical Trials

7. Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine in Immunocompromised Adults

Posters

Oct 21-25, 2020

1. #Vaccine Twitter Influencers: Is it Just About Reach and Followers?

2. Factors Associated with Meningococcal Vaccination Among Patients with Newly Diagnosed High-Risk Conditions

3. Two-Dose 4CMenB Vaccination in Adolescents Elicits Bactericidal Activity Against 15 Outbreak-Representative Meningococcal Strains

4. Prospective Multicenter Observational Cohort Study to Assess the Burden of HZ Disease in the Eye: Baseline Results

5. Assessment of Recombinant Zoster Vaccine Second-Dose Completion in the United States

6. Economic Burden of Herpes Zoster Among Individuals With COPD: A Retrospective Cohort Study

7. The Potential for Reducing Opioid and Analgesic Prescriptions via Herpes Zoster Vaccination

8. Safety Profile of the Adjuvanted Recombinant Zoster Vaccine in Immunocompromised Populations: An Overview of 6 Trials

9. Concomitant Administration of Liquid Porcine Circovirus-free Human Rotavirus Vaccine with Routine Pediatric Vaccines

Posters

April 30 - May 4, 2021 | Virtual

1. POSTER: Estimations of the Cost Of University-based Outbreaks of Serogroup B Meningococcal Disease in the United States

2. POSTER: Meningococcal B Vaccination among Older Adolescents and Young Adults in the United States: an Analysis of Commercial and Medicaid Claims Data

Posters

May 24 - 29, 2021 | Geneva, Switzerland

1. POSTER: The Long-lasting Impact of Invasive Meningococcal Disease (IMD)- Mapping the Comprehensive Range of Sequelae in IMD Survivors

2. ABSTRACT ONLY: Suboptimal 2-dose Completion Rates for Meningococcal B Vaccine Series and Potential Missed Opportunities for Series Completion: Analysis of United States Insurance Claims Data

Posters

September 28 - October 2, 2021 | Virtual

1. POSTER: Safety and Reactogenicity of the Adjuvanted Recombinant Zoster Vaccine: Experience from Clinical Trials and Post-Marketing Surveillance, Fiore et al.

Posters

September 29 - October 3, 2021 | Virtual

1. POSTER: ZOE Placebo groups data show that HZ burden of pain Interferes with activities of daily living, Cabrera et al.

2. POSTER: An easy-to-implement Clinical Trial-Frailty Index based on accumulation of deficits: validation in zoster clinical trails, Andrew et al.

3. POSTER: Is there a correlation between reactogenicity and immune responses of the adjuvanted recombinant zoster vaccine (RZV)? A post-hoc analysis, Callegaro et al.

4. POSTER: Concomitant administration of the adjuvanted recombinant zoster vaccine (RZV) with 13-valent pneumococcal conjugate vaccine (PCV13) is safe and does not interfere with immunogenicity of either vaccine in adults ≥50 years, Min et al.

5. POSTER: Meta-Regression Analysis of Worldwide Herpes Zoster Incidence, Yawn et al.

6. POSTER: Modeled Impact of COVID-19 Pandemic and Associated Reduced Adult Vaccination on Herpes Zoster in the United States, La et al.

7. POSTER: Cost-Effectiveness of Recombinant Zoster Vaccine for Vaccinating Immunocompromised Adults Against Herpes Zoster in the United States, Curren et al.

8. POSTER: Beyone B Antigen Coverage: The Potential of the 4CMenB Vaccine for Cross-Protection Against Pathogenic Neisseria Infections, Garcia et al.

9. POSTER: Clinical Experience With a New Fully Liquid Presentation of the MenACWY-CRM Vaccine Results From Two Multicenter, Randomized, Controlled, Observer-Blind, Phase 2b Studies, Diez-Domingo et al.

Posters

October 11 - 13, 2021 | Athens, Greece

1. POSTER: COVID-19 may increase the risk of herpes zoster in adults ≥50 years of age, Bhavsar et al.

Posters

October 22 - 27, 2021 | Las Vegas, NV

1. POSTER: Burden of Herpes Zoster Among Patients with Ulverative Colitis and Chrohn's Disease in the United States: A Retrospective Cohort Study Using a Large Administrative Claims Database, Singer et al.

Oral Presentations

Apr 27, 2020 | Virtual Annual Meeting I

1. 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. Presentation with Audio: A First-in-Human Phase I Study of the OX40 Agonist GSK3174998 (GSK998) +/- Pembrolizumab in Patients (Pts) With Selected Advanced Solid Tumors (ENGAGE-1)

3. Presentation with Audio: Voice Recording: A phase 1b/2, open-label study of bintrafusp alfa with chemotherapy in patients with stage IV NSCLC

Oral Presentation

December 5-8, 2020 | Virtual

1. Part 1 Results of a Dose Finding Study of Belantamab mafodotin (GSK2857916) in Combination with Pomalidomide (POM) and Dexamethasone (DEX) for the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM)

Oral Presentation

December 5-8, 2020 | Virtual

Posters

December 5-8, 2020 | Virtual

1. DREAMM-2: Single-Agent Belantamab Mafodotin (Belamaf) Effects on Patient-Reported Outcome (PRO) Measures in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

2. Patient-Reported Experiences During and Following Treatment with Belantamab Mafodotin (Belamaf) for Relapsed/Refractory Multiple Myeloma (RRMM) in the DREAMM-2 Study

3. Recovery of Ocular Events with Longer-term Follow-up in the DREAMM-2 Study of Single-Agent Belantamab Mafodotin (Belamaf) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

5. DREAMM-2: Single-Agent Belantamab Mafodotin (Belamaf) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) – 1-Year Outcomes by Prior Therapies

6. DREAMM-5 Platform Trial: Belantamab Mafodotin (Belamaf) in Combination With 4 Different Novel Agents in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

7. DREAMM-6: Safety, Tolerability, and Clinical Activity of Belantamab Mafodotin (Belamaf) in Combination with Bortezomib/Dexamethasone (BorDex) in Relapsed/Refractory Multiple Myeloma (RRMM)

8. DREAMM-7: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) with Bortezomib, and Dexamethasone (B-Vd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

9. 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. Population-level Projections for Multiple Myeloma Patients by Line of Therapy in the USA

11. Exposure–Response (E-R) for Ocular Safety Endpoints for Belantamab Mafodotin (Belamaf), a B-Cell Maturation Antigen (BCMA)-Targeting Agent, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) in the DREAMM-2 Study

Publication Only: Ocular Health of Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Baseline Data From the DREAMM-2 Trial of Belantamab Mafodotin (Belamaf)

Publication Only: Real-world Incidence and Clinical and Economic Burden of Managing Ocular Events (OE) in Patients with Active Multiple Myeloma (MM)

Oral Presentations

September 19-21, 2020 | Virtual

1. Patient-reported outcomes (PRO) in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial ESMO 2020

2. Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient (dMMR) or proficient (MMRp) endometrial cancer: Results from GARNET

Posters

September 19-21, 2020 | Virtual

1. Patient-reported outcomes (PRO) in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial ESMO 2020

2. Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient (dMMR) or proficient (MMRp) endometrial cancer: Results from GARNET

3. Efficacy and Safety of Niraparib in Elderly Patients (Pts) with Advanced Ovarian Cancer (OC): Results from the PRIMA/ENGOT-OV26/GOG-3012 Trial

4. MOONSTONE: A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab in Patients With Platinum Resistant Ovarian Cancer (TiP)

5. JASPER: Efficacy and Safety of First-Line (1L) Niraparib Plus a Programmed Death Receptor-1 Inhibitor (PD-1i) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

6. 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. Safety and efficacy of dostarlimab in patients (pts) with recurrent/advanced non-small cell lung cancer (NSCLC)

8. Matching-Adjusted Indirect Comparisons (MAIC) of Safety Between Single-Agent Belantamab Mafodotin Versus Selinexor Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM)

9. 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. Long-term follow-up of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with pretreated biliary tract cancer

11. Phase 2 study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in platinum-experienced advanced cervical cancer (TiP)

12. A phase 2/3, randomized, placebo-controlled study of bintrafusp alfa with gemcitabine plus cisplatin as first-line treatment of biliary tract cancer (TiP)

13. Three-year follow-up of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, as second-line (2L) treatment of advanced non-small cell lung cancer (NSCLC)

14. Plain Language Summary [HCP USE ONLY]: 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

15. Plain Language Summary [HCP USE ONLY]: GARNET: Results on Dostarlimab in Patients with Recurrent or Advanced dMMR Endometrial Cancer (PROs)

Posters

November 16-19, 2020 | Virtual

1. Economic and Humanistic Outcomes Associated with Treatment of Recurrent or Metastatic Cervical Cancer: A Literature Review

2. Patient Experience Information (PEI) and Patient Involvement in Health Technology Assessment (HTA) Processes in 7 European Countries Using Immuno-Oncology Examples: How Can the Patient Voice Make an Impact?

NY-ESO-1 TCR T Cell (GSK3377794)

Cancer Target Rationale

NY-ESO-1 and LAGE-1a are highly homologous immunogenic cancer-testis antigens that can elicit humoral and cellular immune responses in cancer patients.^1,2
NY-ESO-1 and LAGE-1a are expressed in a wide range of tumor types, with restricted expression in normal tissues.¹

Overview

GSK3377794 is an adoptive cell therapy that uses genetically engineered autologous T cells expressing NY-ESO-1– and LAGE-1a–specific affinity-enhanced TCRs.¹
GSK3377794 is being investigated as a monotherapy and in combination with pembrolizumab in NY-ESO-1– and/or LAGE-1a–positive solid tumors, NSCLC, and relapsed/refractory multiple myeloma.

References:

Thomas R, Al-Khadairi G, Roelands J, et al. NY-ESO-1 based immunotherapy of cancer: current perspectives. Front Immunol. 2018;9:947.
Rapoport AP, Stadtmauer EA, Binder-Scholl GK, et al. NY-ESO-1–specific TCR–engineered T cells mediate sustained antigen-specific antitumor effects in myeloma. Nat Med. 2015;21(8):914-921.

Posters

February 27-29, 2020 | Scottsdale, AZ

Real World Immuno-oncology Treatment Patterns and Outcomes in US Patients with Metastatic Head and Neck Cancer

Oral Presentations

October 3-4, 2020 | Virtual

Presentation: DREAMM-5: Platform Trial Evaluating Belantamab Mafodotin (a BCMA-Directed Immunoconjugate) in Combination With Novel Agents in Relapsed/Refractory Multiple Myeloma (RRMM)

Presentation: DREAMM-2: Pivotal Study Primary Analysis: Single-Agent Belantamab Mafodotin (GSK2857916) in Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to Proteasome Inhibitors (PIs), Immunomodulatory Agents, and Refractory and/or Intolerant to Anti-CD38 Monoclonal Antibodies (mAbs)

Poster

October 3-4, 2020 | Virtual

DREAMM-2: Belantamab Mafodotin (Belamaf) in Patients with Multiple Myeloma Refractory to Proteasome Inhibitors, Immunomodulatory Agents, and Refractory/Intolerant to Anti-CD38 mAb, Including Subgroups With Renal Impairment (RI) and High-Risk (HR) Cytogenetics

Poster

January 23-25, 2020 | San Francisco, CA

Safety and Efficacy of Anti-PD-1 Antibody Dostarlimab in Patients with Mismatch Repair-Deficient (dMMR) GI Cancers

Poster

November 4-7, 2021 | Virtual

1. Healthcare Costs Associated With Systemic Lupus Erythematosus (SLE) in the Year Prior to Diagnosis of End-Stage Kidney Disease (ESKD): Real-World Evidence From Two Databases in the United States

2. Healthcare Resource Utilization and Costs Over 5 Years for a Systemic Lupus Erythematosus (SLE) Cohort Newly Diagnosed With Lupus Nephritis: Evidence From a US Administrative Claims Database

Poster

November 3-9, 2021 | Virtual

1. Efficacy and Safety of Subcutaneous Belimumab (BEL) and Rituximab (RTX) Sequential Therapy in Patients with Systemic Lupus Erythematosus: The Phase 3, Randomized, Placebo-Controlled BLISS-BELIEVE Study

2. Belimumab Reduces Severe Flares in Systemic Lupus Erythematosus Across Multiple Patient Subgroups: Results of a Large Integrated Analysis

3. Effect of Belimumab on Autoantibodies, Complement and B cell Subsets in Patients with Lupus Nephritis

4. Year-3 Observational Follow-up of Belimumab Safety (Mortality and Malignancies) in Patients with SLE who Completed a Phase 4, 52-Week, Randomized, Double-Blind, Placebo-Controlled Safety Study

5. Sequential Administration of Belimumab and Rituximab in Primary Sjögren’s Syndrome Reduces Minor Salivary Gland-Resident B Cells and Delays B-cell Repopulation in Circulation

6. Reduction in Glucocorticoid Use in Patients with Systemic Lupus Erythematosus Treated with Belimumab: A Large Pooled Analysis of 5 Placebo Controlled Studies

7. Characterizing patient and physician perceptions of systemic lupus erythematosus (SLE) disease burden using traditional rheumatoid arthritis outcomes measures

Poster

August 12-15, 2021 | Destin, FL | Virtual

1. Efficacy of Belimumab Across Multiple Organ Domains in Systemic Lupus Erythematosus: Results of a Large Integrated Analysis

2. Healthcare Costs Associated With Systemic Lupus Erythematosus in the 5-year Period Prior to Diagnosis of End-Stage Kidney Disease

Poster

June 2-5, 2021 | Virtual

1. BLISS-LN OLE: A 6-Month Open-Label Extension Study of the Safety and Efficacy of Intravenous Belimumab in Patients With Lupus Nephritis

2. Development of a Conceptual Model to Understand Disease Burden in Patients with Systemic Lupus Erythematosus and Long-Term Organ Damage

3. Epidemiology of Lupus Nephritis in Brazil: Findings From the Macunaíma Study – A Nationwide Multicentric Study

4. Mapping the Nationwide Clinical Profile and Patterns of Care of SLE in Brazil – Findings From the Macunaíma Study

5. Safety and Efficacy of Belimumab in Older Adults with Systemic Lupus Erythematosus: Results of an Integrated Analysis

6. Safety of Belimumab in Adult Patients With Systemic Lupus Erythematosus: A Large Integrated Safety Analysis of Controlled Clinical Trial Data

Poster

June 2-5, 2021 | Virtual

1. Safety and Efficacy of Subcutaneous Belimumab and Intravenous Rituximab Combination Patients with Primary Sjögren’s Syndrome: A Phase 2, Randomized, Placebo-Controlled 68-Week Study

Oral Presentations

November 3-9, 2021 | Virtual

1. Belimumab Improves Renal Responses in Patients With or Without Steroid Pulses During Induction Therapy for Lupus Nephritis

Oral Presentations

November 4-7, 2021 | Virtual

1. Effects of Belimumab (BEL) on Renal Outcomes in Patients (pts) With Relapsed and Newly Diagnosed Active Lupus Nephritis (LN)

Poster

May 18-20, 2020 | Virtual

1. Real-World Average Dose of PARP Inhibitors Used as Maintenance Therapy for Platinum-Sensitive Recurrent Ovarian Cancer

Posters

January 28-31, 2021 | Virtual

1. Niraparib + Pembrolizumab (Pembro) Versus Placebo + Pembro 1L Maintenance Therapy in Advanced NSCLC: ZEAL-1L Phase III Study

2. CD8α-enhanced NY-ESO-1-Specific TCR T Cells (GSK3901961) in HLA-A*02 Patients with NSCLC: Master Protocol Substudy 1

Oral Presentations

May 29-June 2, 2020 | Virtual

1.ORAL PRESENTATION:DREAMM-6: Safety and Tolerability of Belantamab Mafodotin in Combination with Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM)

2. PLAIN LANGUAGE SUMMARY [HCP USE ONLY]: The DREAMM-6 Study: What Side Effects Were Experienced When Patients With Multiple Myeloma Were Treated With Belantamab Mafodotin in Combination With Another Anti-Myeloma Treatment, Bortezomib/Dexamethasone?

Posters

May 29-June 2, 2020 | Virtual

1. 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. POSTER: Niraparib Exposure-Response Relationship in Patients (pts) with Newly Diagnosed Advanced Ovarian Cancer (AOC)

3. POSTER: Evaluation of an Individualized Starting Dose of Niraparib in the PRIMA/ENGOT-OV26/GOG-3012 Study

4. POSTER: Pharmacokinetics and Safety Following a Single Oral Dose of Niraparib in Patients with Moderate Hepatic Impairment

5. POSTER: ENGOT-EN6/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)

6. 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

7. POSTER: Belantamab Mafodotin (GSK2857916) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) and High-Risk (HR) Cytogenetics in DREAMM-2

8. POSTER: DREAMM-9: Phase 3 Study of Belantamab Mafodotin Plus VRd vs VRd Alone in Transplant Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)

9. POSTER: DREAMM-2: Single-Agent Belantamab Mafodotin (GSK2857916) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and Renal Impairment

10. 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?

11. POSTER: DREAMM-2: Single-Agent Belantamab Mafodotin in Relapsed/Refractory Multiple Myeloma Refractory to Proteasome Inhibitors, Immunomodulatory Agents, and Refractory and/or Intolerant to Anti-CD38 mAbs

12. PLAIN LANGUAGE SUMMARY [HCP USE ONLY]: The DREAMM-2 Study: Effects of Belantamab Mafodotin in Patients With Multiple Myeloma Who Had Already Been Treated Unsuccessfully With Several Anti-Myeloma Treatments

13. POSTER: DREAMM-5 Platform Trial: Belantamab Mafodotin in Combination With Novel Agents in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

14. POSTER: INDUCE-1: Report on safety run-in cohorts combining the Inducible T cell co-stimulatory receptor (ICOS) agonist GSK3359609 (GSK609) with platinum+5FU chemotherapy, with or without pembrolizumab (pembro), for the treatment of advanced solid tumors

15. POSTER: INDUCE-3: A Randomized, Double-Blind Study of GSK3359609 (GSK609), an Inducible T-cell Co-Stimulatory (ICOS) Agonist Antibody, Plus Pembrolizumab (PE) Versus Placebo (PL) Plus PE for First-Line Treatment of PD-L1-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

16. 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-Naïve Head and Neck Squamous Cell Carcinoma (HNSCC)

17. ENCORE: Open-Label Pilot Study of Genetically Engineered NY-ESO-1 Specific T Cells (GSK3377794) Alone or in Combination with Pembrolizumab in Relapsed and Refractory Multiple Myeloma

18. ENCORE: Safety and activity of autologous T cells with enhanced NY-ESO-1–specific T-cell receptor (GSK3377794) in HLA-a*02+ previously-treated and -untreated patients with advanced metastatic/unresectable synovial sarcoma: A master protocol study design (IGNYTE-E)

19. POSTER: BET Inhibitor Molibresib for the Treatment of Advanced Solid Tumors: Final Results From an Open-Label Phase I/II study

20. POSTER: Two-Year Follow-Up of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, for Second-Line (2L) Treatment of Non-Small Cell Lung Cancer (NSCLC)

21. PUBLICATION ONLY: Real-World Treatment Patterns of Maintenance therapy in Platinum-Sensitive Recurrent Epithelial Ovarian Cancer: Are Some Patients Missing Out?

22. PUBLICATION ONLY: Treatment Patterns of Advanced or Recurrent Endometrial Cancer Following Platinum-Based Therapy in the US Real-World Setting

23. PUBLICATION ONLY: Patient-reported outcomes (PRO) in the GARNET trial in patients (pts) with advanced or recurrent dMMR/MSI-H endometrial cancer (EC) treated with dostarlimab

24. PUBLICATION ONLY: DREAMM-1: Patient Perspectives from the First-in-Human Study of Single-Agent Belantamab Mafodotin for Relapsed and Refractory Multiple Myeloma (RRMM)

25. PUBLICATION ONLY: DREAMM-2: Assessing Efficacy via Indirect Comparison of Single-Agent Belantamab Mafodotin Versus Selinexor Plus Dexamethasone Combination in Anti-CD38 Exposed Relapsed/Refractory Multiple Myeloma

26. PUBLICATION ONLY: Current Treatment Efficacy for Metastatic Soft Tissue Sarcoma: A Targeted Literature Review

27. PUBLICATION ONLY: Qualitative Patient Interviews on Symptoms and Impacts in Metastatic Synovial Sarcoma (mSS)

28. PUBLICATION ONLY: Epidemiology of Adenoid Cystic Carcinoma in the United States

Symposia

May 29-June 2, 2020 | Virtual

SYMPOSIUM: Advances in Targeting of B-cell Maturation Antigen (BCMA) as an Investigational Novel Approach in Multiple Myeloma

IMPORTANT NOTICE

IMPORTANT NOTICE

Oncology