TIDMGSK
RNS Number : 3105L
GlaxoSmithKline PLC
18 April 2018
Issued: 18 April 2018, London UK - LSE Announcement
Landmark IMPACT study published in NEJM shows significant
benefits of Trelegy Ellipta for patients with COPD
Once-daily single inhaler triple therapy superior to Relvar/Breo
Ellipta and Anoro Ellipta across multiple endpoints including
exacerbations, lung function and quality of life
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced the publication in the New England Journal of
Medicine (NEJM) of the landmark IMPACT study, one of the biggest
ever conducted in patients with chronic obstructive pulmonary
disease (COPD) with a history of exacerbation.(1)
In the study, Trelegy Ellipta (fluticasone
furoate/umeclidinium/vilanterol, 'FF/UMEC/VI' 100/62.5/25mcg)
achieved superiority to members of two different classes of dual
combination therapy, Relvar/Breo (FF/VI) and Anoro (UMEC/VI), on
the primary endpoint of reduction in the annual rate of
on-treatment moderate/severe exacerbations (p<0.001) and a range
of other clinically important outcomes, including lung function and
health-related quality of life.
Results from additional secondary and other endpoints published
today, include:
-- A statistically significant 34% reduction in COPD
hospitalisations (severe exacerbations) for Trelegy compared to
Anoro (0.13 vs. 0.19 per year; p<0.001) and a reduction of 13%
compared to Relvar/Breo which was not statistically significant
(0.13 vs. 0.15; p=0.064).
-- A significant reduction in the risk of on-treatment all-cause
mortality was observed for both inhaled corticosteroid containing
arms compared to Anoro.
-- A 42.1% reduction in the risk of on-treatment all-cause
mortality was observed for Trelegy compared to Anoro (1.20% vs.
1.88%; p=0.011).
To fully understand the implications of the all-cause mortality
observation, off-treatment data also need to be considered. Work is
ongoing to investigate this further and will be presented at future
scientific meetings.
Dave Allen, Head, Respiratory Therapy Area R&D, GSK, said,
"Reducing exacerbations to keep patients out of hospital is a key
goal of COPD management alongside improving lung function and
quality of life. The IMPACT study shows how Trelegy Ellipta can
help patients with a history of exacerbation achieve these goals.
We believe its publication in NEJM is an important addition to the
evidence base that informs the management of this progressive and
debilitating disease."
Dr. Fernando Martinez, Chief, Division of Pulmonary and Critical
Care Medicine, New York-Presbyterian Hospital/Weill Cornell Medical
Center, said, "IMPACT significantly advances our understanding of
COPD management by addressing a number of key evidence gaps. By
comparing various combinations of effective medications in the same
device the study clarifies which type of patient gains greatest
benefit from each class of medicine. As many patients experience
frequent exacerbations or 'flare ups', which can often result in
hospitalisation, these data will be highly relevant to patients and
clinicians as they consider the optimal treatment."
The safety profile of single inhaler triple therapy was
consistent with the safety profile of the individual components.
The most common adverse events across the treatment groups were
viral upper respiratory tract infection, worsening of COPD, upper
respiratory tract infection, pneumonia and headache. Consistent
with previous studies, the incidence of pneumonia as a serious
adverse event was 4%, 4%, and 3% for FF/UMEC/VI, FF/VI and UMEC/VI,
respectively.
Dr Ted Witek, Senior Vice President and Chief Scientific Officer
at Innoviva notes, "The role of inhaled corticosteroids ("ICS") in
COPD have long been debated, and this landmark trial provides
further evidence of their benefit in the population studied and
compelling data towards clarifying the role of ICS containing
regimens in the COPD treatment paradigm. We congratulate our
partners at GSK for this vital contribution to the field of
respiratory medicine."
Results from IMPACT were submitted to the regulatory authorities
in the US and EU in November 2017 and February 2018, respectively.
Further regulatory submissions in other countries are expected in
2018.
About IMPACT
The landmark InforMing the PAthway of COPD Treatment (IMPACT)
study is the first to directly compare three commonly-used COPD
combination treatment classes delivered using the same dose and
inhaler. It is the second of two phase 3 studies designed to
investigate the efficacy and safety of FF/UMEC/VI in a single
inhaler compared to other commonly-used COPD combination
treatments.(2)
It evaluated as its primary endpoint the annual rate of
on-treatment moderate/severe exacerbations for FF/UMEC/VI
(100/62.5/25mcg) compared with FF/VI (100/25mcg) and UMEC/VI
(62.5/25mcg), two once-daily dual COPD therapies from GSK's
existing portfolio. Other secondary and multiple pre-defined
protocol 'other' endpoints included lung function, patient reported
outcomes, including health- related quality of life measures, and
all-cause mortality. A range of safety endpoints were also
analysed.
Patients had moderate to very severe symptomatic COPD with a
history of exacerbation in the prior 12 months. This is
representative of approximately 50% of the global COPD patient
population.(3) In the study, 10,355 patients were treated in 37
countries in over 1,035 study centres globally, making it one of
the biggest COPD studies ever conducted.
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 was approved in the US in September 2017 for the
long-term, once-daily, maintenance treatment of patients with COPD,
including chronic bronchitis and/or emphysema, who are on a
fixed-dose combination of FF/VI for airflow obstruction and
reducing exacerbations in whom additional treatment of airflow
obstruction is desired or for patients who are already receiving
UMEC and a fixed-dose combination of FF/VI.
Full US Prescribing Information, including BOXED WARNING and
Medication Guide are available at:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Trelegy/pdf/TRELEGY-PI-MG-IFU.PDF
FF/UMEC/VI was approved for use in Europe in November 2017 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
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.
About COPD
COPD is a progressive lung disease that is thought to affect
around 384 million people worldwide.(4)
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.(5)
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.
Important Safety Information (ISI)
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.
Long-acting beta2-adrenergic agonists (LABA), such as
vilanterol, increase the risk of asthma-related death. A
placebo-controlled trial with another LABA (salmeterol) showed an
increase in asthma-related deaths. This finding with salmeterol is
considered a class effect of all LABA. The safety and efficacy of
Trelegy Ellipta in patients with asthma have not been established.
Trelegy Ellipta is not indicated for the treatment of asthma.
Trelegy Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or any of the ingredients.
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 headache, back pain, dysgeusia, diarrhea,
cough, oropharyngeal pain, and gastroenteritis.
GSK - a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
Trade marks are owned by or licensed to the GSK group of
companies.
Innoviva - Innoviva is focused on bringing compelling medicines
to patients in areas of unmet need by leveraging its significant
expertise in the development, commercialization and financial
management of bio-pharmaceuticals. Innoviva's portfolio is anchored
by the respiratory assets partnered with Glaxo Group Limited (GSK),
including RELVAR(R) /BREO(R) ELLIPTA(R) , ANORO(R) ELLIPTA(R) and
TRELEGY(R) ELLIPTA(R) , which were jointly developed by Innoviva
and GSK. Under the agreement with GSK, Innoviva is eligible to
receive associated royalty revenues from RELVAR(R) /BREO(R)
ELLIPTA(R) and ANORO(R) ELLIPTA(R) . In addition, Innoviva retains
a 15 percent economic interest in future payments made by GSK for
TRELEGY(R) ELLIPTA(R) and earlier-stage programs partnered with
Theravance Biopharma, Inc. For more information, please visit
Innoviva's website at www.inva.com.
GSK enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
US Media enquiries: Karen Hagens +1 919 483 (North Carolina)
2863
Juan Carlos +1 919 483 (North Carolina)
Molina 0471
Sarah Spencer +1 215 751 (Philadelphia)
3335
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
enquiries: 8047 5194
Tom Curry + 1 215 751 (Philadelphia)
5419
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
Innoviva, Inc.
enquiries:
Investor Relations: Eric d'Esparbes +1 (650) 238-9640 (Brisbane,
investor.relations@inva.com Calif.)
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.
Innoviva forward-looking statements
This press release contains certain "forward-looking"
statements as that term is defined in the Private
Securities Litigation Reform Act of 1995 regarding,
among other things, statements relating to goals,
plans, objectives and future events, including
the development, regulatory and commercial plans
for closed triple combination therapy and the
potential benefits and mechanisms of action of
closed triple combination therapy. Innoviva intends
such forward-looking statements to be covered
by the safe harbor provisions for forward-looking
statements contained in Section 21E of the Securities
Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Such forward-looking
statements involve substantial risks, uncertainties
and assumptions. These statements are based on
the current estimates and assumptions of the
management of Innoviva as of the date of this
press release and are subject to risks, uncertainties,
changes in circumstances, assumptions and other
factors that may cause the actual results of
Innoviva to be materially different from those
reflected in the forward-looking statements.
Important factors that could cause actual results
to differ materially from those indicated by
such forward-looking statements are described
under the headings "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition
and Results of Operations" contained in Innoviva's
Annual Report on Form 10-K for the year ended
December 31, 2017, which is on file with the
Securities and Exchange Commission (SEC) and
available on the SEC's website at www.sec.gov.
Additional factors may be described in those
sections of Innoviva's Quarterly Report on Form
10-Q for the quarter ended March 31, 2018, to
be filed with the SEC in the second quarter of
2018. In addition to the risks described above
and in Innoviva's other filings with the SEC,
other unknown or unpredictable factors also could
affect Innoviva's results. No forward-looking
statements can be guaranteed and actual results
may differ materially from such statements. Given
these uncertainties, you should not place undue
reliance on these forward-looking statements.
The information in this press release is provided
only as of the date hereof, and Innoviva assumes
no obligation to update its forward-looking statements
on account of new information, future events
or otherwise, except as required by law. (INVA-G)
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References (accessed March 2018)
1. Lipson DA et al. Once-Daily Single Inhaler Triple Versus Dual
Therapy in Patients with COPD. New England Journal of Medicine.
2018.
2. Lipson DA et al. FULFIL Trial: Once-Daily Triple Therapy for
Patients with Chronic Obstructive Pulmonary Disease. Am J Resp Crit
Care Med. 2017.
3. GSK data on file. RF/CPD/0003/18. Frequency of acute
exacerbations of COPD among patients treated with maintenance
therapy in three observational studies.
4. Global Strategy for the Diagnosis, Management and Prevention
of COPD, Global Initiative for Chronic Obstructive Lung Disease
(GOLD) 2017. Available from: http://goldcopd.org.
5. Diagnosis of COPD. World Health Organization. Available at: http://www.who.int/respiratory/copd/diagnosis/en/
This information is provided by RNS
The company news service from the London Stock Exchange
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