GSK Data Presented at ERS Further Supports Its Industry-Leading Respiratory Medicines Portfolio

GlaxoSmithKline plc (GSK) will profile the growing evidence base that supports its broad respiratory medicines portfolio at the European Respiratory Society (ERS) congress in Paris, France, 15-19 September 2018. Issued: London, UK Data presented in 50 abstracts will underscore the therapeutic value of key medicines across a spectrum of patients...

GlaxoSmithKline plc (GSK) will profile the growing evidence base that supports its broad respiratory medicines portfolio at the European Respiratory Society (ERS) congress in Paris, France, 15-19 September 2018.

Issued: London, UK

Data presented in 50 abstracts will underscore the therapeutic value of key medicines across a spectrum of patients with asthma and chronic obstructive pulmonary disease (COPD).

Data presented will include new analyses from clinical studies across the medicines portfolio. These data provide evidence of the role different treatments have in optimising the management of respiratory diseases by addressing the main areas of individual patient need. Findings include the effect on exacerbations, or worsening of the condition, that many COPD and asthma patients suffer, as well as on lung function, symptoms such as breathlessness and quality of life. Data will also be presented assessing the benefit of treatments across disease severities and age groups.

Optimising COPD treatment

New analyses of data from the landmark IMPACT study will help to clarify which patients can gain the greatest benefit from the different COPD combination treatment classes in the study, to provide further evidence on the right treatment for the right patient.

  • The benefit/risk profile of once-daily single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) in COPD patients with a history of exacerbations is presented in a further analysis. (Abstract no: PA1991)
  • Comparisons of the two dual treatments studied in IMPACT, Anoro Ellipta (UMEC/VI) and Relvar/Breo Ellipta (FF/VI), will be presented for the first time, providing further evidence on the role of dual bronchodilation in COPD symptom management. (Abstract no: PA4384, PA4385)

Building the evidence for targeted biologic therapy

Development of the first-in-class anti-IL5 biologic Nucala (mepolizumab) represents a scientific innovation that is enabling a more targeted approach to the treatment of patients with severe eosinophilic asthma (SEA) and eosinophilic granulomatosis with polyangiitis(EGPA). In addition, Nucala is under investigation for patients with COPD, hypereosinophilic syndrome (HES) and nasal polyps. Key presentations focus on the growing evidence assessing its role in the reduction of exacerbations across a range of age groups and disease severities in SEA.

  • New results from the COSMEX study looks at long-term safety & durability in patients with life-threatening/seriously debilitating SEA for up to 4.5 years. (Abstract no: OA3566)
  • Efficacy data will be presented comparing the effect of investigational treatment in children with SEA with results in adolescents and adults. (Abstract no: PA5447)

In total, GSK will present data from 50 abstracts, including 13 oral presentations and 16 discussion and 21 thematic poster presentations.

Table of key abstracts:

Medicine

Title

Author

Presentation

Abstract /poster number

FF/UMEC/VI (GSK2834425)

Exacerbation outcomes with LAMA/LABA and ICS/LABA in high risk COPD patients in the IMPACT trial

Lipson DA, Barnhart F,
Boucot I, Crim C,
Brealey N, Criner G,
Dransfield M, Halpin D,
Kilbride S, Han MK,
Lange P, Lomas D,
Martinez FJ, Singh D,
Naya I, Jones CE,
Wise R

Thematic poster
COPD management
Tuesday 18th September 2018
12:50 - 14:40
TP-23
Session 444

PA4384

FF/UMEC/VI (GSK2834425)

Analysis of the InforMing the PAthway of COPD Treatment (IMPACT) study in the subgroup of patients taking triple therapy at screening

Singh D, Criner G,
Day NC, Dransfield M, Halpin DMG, Han MK,
Jones CE, Kilbride S,
Lange P, Lipson DA,
Lomas DA, Pascoe S,
Tabberer T, Wise R,
Martinez FJ

Oral presentation
COPD: from LABA/ICS to LABA/LAMA/ICS
Monday 17th September 2018
10:45 - 12:45 (Presentation time 11:45 - 12:00)
7.3Z2
Session 244

OA2129

FF/UMEC/VI (GSK2834425)

Blood eosinophil counts and treatment response in COPD: analyses of IMPACT

Pascoe S, Barnes N, Brusselle G, Compton C, Criner G, Dransfield M, Halpin DMG, Han MK,
Hartley B, Hilton E, Lange P, Lettis S, Lipson DA,
Lomas D, Martinez FJ,
Papi A, Roche N, van der Valk RJP, Wise R, Singh D

Oral presentation
COPD: from LABA/ICS to LABA/LAMA/ICS
Monday 17th September 2018
10:45 - 12:45 (Presentation time 11:15 - 11:30)
7.3Z2
Session 244

OA2127

FF/UMEC/VI (GSK2834425)

Comparison of LAMA/LABA vs ICS/LABA in high risk COPD patients: Pre-specified analysis on lung function and health status from the IMPACT trial

Lipson DA, Barnhart F, Criner G, Wise R,
Lomas D, Halpin D,
Lange P, Brealey N, Dransfield M, Kilbride S, Martinez FJ, Singh D, Boucot I, Naya I, Han M, Jones CE, Crim C

Thematic poster
COPD management
Tuesday 18th September 2018
12:50 - 14:40
TP-23
Session 444

PA4385

mepolizumab (SB240563)

Mepolizumab for severe eosinophilic asthma: a comparison of efficacy in children, adolescents, and adults

Gupta A, Steinfeld J,
Price R, Azmi J, Bradford E, Yancey S

Poster discussion
New developments in paediatric asthma
Wednesday 19th September 2018
10:45 - 12:45
7.2B
Session 557

PA5447

mepolizumab (SB240563)

Long-term safety & durability of mepolizumab in life-threatening/seriously debilitating severe eosinophilic asthma (SEA): COSMEX

Albers F, Khurana S, Bradford E, Gilson M,
Price R, Brusselle G, Bel E, Fitzgerald M, Masoli M, Korn S, Humbert M

Oral presentation
Notable Studies in Asthma
Tuesday 18th September 2018
08:30 - 10:30 (Presentation time: 08:45 - 09:00)
7.3Z2
Session 379

OA3566

mepolizumab (SB240563)

Eosinophils as predictor of mepolizumab treatment responses in COPD

Pavord I, Criner G, Kerstjens H, Bradford E, Harris S, Keene O, Mayer B, Rubin D, Yancey S,
Bratton D

Poster discussion
Integrating pharmacological and non-pharmacological management in COPD: are we there yet?
Monday 17th September 2018
08:30 - 10:30
7.2A
Session 225

PA1992

mepolizumab (SB240563)

Immunogenicity of Mepolizumab in Patients with Severe Eosinophilic Asthma: Experience from the Clinical Development Program

Ortega H, Meyer E, Brusselle G, Asano K,

Price R, Prazma C,

Albers F, Yancey S,

Gleich G

Oral presentation

Novel immunology-based therapies in asthma and COPD

Sunday 16th September 2018

14:45 - 16:45 (Presentation time: 15:45 - 16:00)

7.3O

Session 176

OA1650

umeclidinium/vilanterol trifenatate (GSK2592356)

Economic and quality of life consequences of clinically important deterioration in patients with COPD: Results from the TORCH Study

Naya I, Driessen M,

Gunsoy N, Ismaila A, Risebrough N, Paly V, Briggs A

Oral Presentation

Clinical trials in COPD: new results

Sunday 16th September 2018

14:45 - 16:45 (Presentation time: 16:15 - 16:30)

7.3P

Session 177

OA1660

ambrisentan (GSK1325760)

Early improvements predict outcomes in pulmonary arterial hypertension

White RJ, Hoeper MM,

Blair C, Langley J,

Vizza CD

Oral Presentation

Risk stratification in treatment of pulmonary arterial hypertension

Sunday 16th September 2018

08:30 - 10:30 (Presentation time: 09:00 - 09:15)

7.3B

Session 47

OA269

About asthma

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms impacting their daily life. It is estimated that 5-10% of all asthma patients have severe asthma.

The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

About COPD

COPD is a progressive lung disease that is thought to affect around 384 million people worldwide.

For people living with COPD, the inability to breathe normally can consume their daily lives and make simple activities, like walking upstairs, an everyday struggle. Patients with COPD suffer from symptoms of breathlessness and many have a significant risk of exacerbations. Managing these aspects of the disease drives physician treatment choice.

Long-term exposure to inhaled irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

Every person with COPD is different, with different needs, different challenges and different goals. Understanding this and providing support to help meet these needs is the foundation of GSK’s work.

GSK’s commitment to respiratory disease

GSK has led the way in developing innovative medicines to advance the management of asthma and COPD for nearly 50 years. Over the last five years we have launched six innovative medicines responding to continued unmet patient need, despite existing therapies. This is an industry-leading portfolio in breadth, depth and innovation, developed to reach the right patients, with the right treatment.

We remain at the cutting-edge of scientific research into respiratory medicine, working in collaboration with patients and the scientific community to offer innovative medicines aimed at helping to treat patients’ symptoms and reduce the risk of their disease worsening. While respiratory diseases are clinically distinct, there are important pathophysiological features that span them, and our ambition is to have the most comprehensive portfolio of medicines to address a diverse range of respiratory diseases. To achieve this, we are focusing on targeting the underlying disease-driving biological processes to develop medicines with applicability across multiple respiratory diseases. This approach requires extensive bioinformatics, data analytic capabilities, careful patient selection and stratification by phenotype in our clinical trials.

About Trelegy Ellipta (FF/UMEC/VI)

FF/UMEC/VI is the first COPD treatment to provide a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler, which is used across the entire new portfolio of inhaled COPD medicines. Data from across multiple clinical programmes have demonstrated the benefit of the molecules in FF/UMEC/VI both alone and in combination, for the treatment of COPD.

FF/UMEC/VI is approved for use in Europe as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. The European Summary of Product Characteristics is available at: https://www.medicines.org.uk/emc/medicine/34357

FF/UMEC/VI is approved in the US for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. It is not indicated for relief of acute bronchospasm or for the treatment of asthma.

Full US Prescribing Information, including Patient Information is available at: https://gsk.to/2wXFur8

Regulatory applications for once-daily single inhaler triple therapy FF/UMEC/VI have been submitted and are undergoing assessment in a number of other countries.

Important Safety Information (ISI) for Trelegy Ellipta

The following ISI is based on the Highlights section of the US Prescribing Information for FF/UMEC/VI. Please consult the full Prescribing Information for all the labelled safety information.

Trelegy Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or any of the ingredients.

LABA monotherapy increases the risk of serious asthma-related events.

Trelegy Ellipta should not be initiated in patients experiencing episodes of acutely deteriorating COPD. Do not use Trelegy Ellipta to treat acute symptoms.

Trelegy Ellipta should not be used in combination with other medicines containing LABA because of risk of overdose.

Candida albicans infection of the mouth and pharynx has occurred in patients treated with fluticasone furoate, a component of Trelegy Ellipta. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.

There is an increased risk of pneumonia in patients with COPD taking Trelegy Ellipta. Monitor patients for signs and symptoms of pneumonia.

Patients who use corticosteroids are at risk for potential worsening of infections (e.g. existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex). Use Trelegy Ellipta with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

There is a risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Trelegy Ellipta.

Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of Trelegy Ellipta in susceptible individuals. If such changes occur, consider appropriate therapy.

If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta and institute alternative therapy.

Use Trelegy Ellipta with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.

Assess patients for decrease in bone mineral density initially and periodically thereafter after prescribing Trelegy Ellipta.

Close monitoring for glaucoma and cataracts is warranted in patients taking Trelegy Ellipta. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur.

Worsening of urinary retention may occur in patients taking Trelegy Ellipta. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.

Use Trelegy Ellipta with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

Be alert to hypokalemia and hyperglycemia in patients taking Trelegy Ellipta.

The most common adverse reactions reported for Trelegy Ellipta (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.

About Nucala (mepolizumab)

Nucala 100mg is the market leading biologic treatment for patients with severe eosinophil asthma. It is in the US, Europe and over 20 other markets and has been prescribed to over 18,000 patients in the US. It has been studied in over 3,000 patients in 16 clinical trials across a number of eosinophilic conditions. Nucala 300mg was recently approved in the US for the treatment of adult patients with a rare disease called eosinophilic granulomatosis with polyangiitis (EGPA). An sBLA has also been filed for the treatment in patients with chronic obstructive pulmonary disease and is currently being investigated for severe hypereosinophilic syndrome and nasal polyposis.

In the US, Nucala (100mg fixed dose subcutaneous injection of mepolizumab) is licensed as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala (3x 100mg subcutaneous injection of mepolizumab) is licensed for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Nucala is not approved for the relief of acute bronchospasm or status asthmaticus. Full US Prescribing Information is available at US Prescribing Information Nucala.

In the EU, Nucala (100mg fixed dose subcutaneous injection of mepolizumab) is licensed as an add-on treatment for severe refractory eosinophilic asthma in adult and in paediatric patients aged six up to 17 years. For the EU Summary of Product Characteristics for Nucala, please visit: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003860/WC500198037.pdf

Important Safety Information for Nucala

The following information is based on the US Prescribing Information for Nucala. Please consult the full Prescribing Information for all the labelled safety information for Nucala.

CONTRAINDICATIONS

Nucala should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (e.g. anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of Nucala. These reactions generally occur within hours of administration but in some instances can have a delayed onset (i.e. days). In the event of a hypersensitivity reaction, Nucala should be discontinued.

Acute Asthma Symptoms or Deteriorating Disease

Nucala should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster

In controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred in subjects treated with Nucala compared to none in placebo. Consider varicella vaccination if medically appropriate prior to starting therapy with Nucala.

Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with Nucala. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

It is unknown if Nucala will influence a patient’s response against parasites. Treat patients with pre-existing helminth infections before initiating therapy with Nucala. If patients become infected while receiving treatment with Nucala and do not respond to anti-helminth treatment, discontinue treatment with Nucala until infection resolves.

ADVERSE REACTIONS

The most common adverse reactions (≥3% and more common than placebo) reported in the first 24 weeks of two clinical trials with Nucala (and placebo) were: headache, 19% (18%); injection site reaction, 8% (3%); back pain, 5% (4%); fatigue, 5% (4%); influenza, 3% (2%); urinary tract infection 3% (2%); abdominal pain upper, 3% (2%); pruritus, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3% (<1%).

Systemic Reactions, including Hypersensitivity Reactions: In 3 clinical trials, 3% of subjects who received Nucala experienced systemic (allergic and nonallergic) reactions compared to 5% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 1% of subjects who received Nucala compared to 2% of subjects in the placebo group. Manifestations included rash, pruritus, headache, and myalgia. Systemic nonallergic reactions were reported by 2% of subjects who received Nucala and 3% of subjects in the placebo group. Manifestations included rash, flushing, and myalgia. A majority of the systemic reactions were experienced on the day of dosing. Reports of anaphylaxis have been received postmarketing.

Injection site reactions (e.g. pain, erythema, swelling, itching, burning sensation) occurred at a rate of 8% in subjects treated with Nucala compared with 3% in subjects treated with placebo.

USE IN SPECIFIC POPULATIONS

The data on pregnancy exposures from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are progressively transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a foetus are likely to be greater during the second and third trimesters of pregnancy.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com/about-us.

Trade marks are owned by or licensed to the GSK group of companies.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2017.

Source: us.gsk.com