GSK and Innoviva Report Positive Headline Results from IMPACT Study Showing Single Inhaler Triple Therapy Trelegy Ellipta
Reduced COPD Exacerbations
Trelegy Ellipta met study primary endpoint demonstrating reduction in exacerbations compared with the dual therapies Anoro
Ellipta and Relvar/Breo Ellipta in patients with COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced positive headline results from the
landmark phase III IMPACT study of Trelegy Ellipta, the first and only FDA approved once-daily single inhaler triple therapy
comprising an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA).
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) is approved for the long-term, once-daily, maintenance
treatment of patients with chronic obstructive pulmonary disease (COPD) who are receiving Breo (fluticasone furoate/vilanterol, FF/
VI) and require additional bronchodilation or who are receiving Breo and Incruse (umeclidinium, UMEC).
The IMPACT study, which involved 10,355 patients, met its primary endpoint demonstrating statistically significant reductions in
the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) when compared with two, once-daily
dual COPD therapies from GSK’s existing portfolio. The study showed a:
- 15% reduction for FF/UMEC/VI compared with Relvar/Breo Ellipta (FF/VI,100/25mcg);
0.91 vs 1.07 per year; p<0.001
- 25% reduction for FF/UMEC/VI compared with Anoro Ellipta (UMEC/VI, 62.5/25mcg);
0.91 vs 1.21 per year; p<0.001
In addition, statistically significant improvements were observed across all pre-specified key secondary endpoints and
associated treatment comparisons:
- Change from baseline trough FEV1 at week 52 for FF/UMEC/VI compared with FF/VI was 97mL;
p<0.001 and for FF/UMEC/VI compared with UMEC/VI was 54mL; p<0.001
- Change from baseline St George’s Respiratory Questionnaire at week 52 for FF/UMEC/VI compared with
FF/VI was -1.8 units; p<0.001 and for FF/UMEC/VI compared with UMEC/VI was -1.8 units; p<0.001
- Analysis of time to first on-treatment moderate/severe COPD exacerbation demonstrated a 14.8%
reduction in risk for FF/UMEC/VI compared with FF/VI; p<0.001, and a 16.0% reduction in risk for FF/UMEC/VI compared with
UMEC/VI; p<0.001
Based on review of the headline data, the safety profile of once-daily FF/UMEC/VI was consistent with the known profile of the
individual medicines and their dual combinations. 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. The incidences of common
serious adverse events were worsening of COPD 11%, 11% and 13% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively; for pneumonia was
4%, 4% and 3% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively.
Patrick Vallance, President R&D, GSK, said: “We are delighted with the positive results achieved in the IMPACT study. This
is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed
clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations. It is important to note that all
treatments were comprised of different combinations of the same component molecules administered in the same Ellipta inhaler, in a
single dose, once a day to allow direct treatment comparisons. We hope these results will inform global guidelines and look forward
to sharing the results with regulatory authorities. We will continue to analyse the wealth of data generated to further the
understanding of the treatment of COPD.”
Mike Aguiar, CEO of Innoviva, Inc., commented: “The results of the IMPACT study have been long awaited by the medical community.
We believe these data will significantly contribute to the body of evidence on the use of single inhaler triple therapy, as well as
the ongoing role of ICS/LABA and LAMA/LABA treatments in appropriate patients with COPD.”
Full results will be presented at upcoming scientific meetings and in peer-reviewed publications.
On 14 September 2017 GSK and Innoviva, Inc. announced EU Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing
authorisation for Trelegy Ellipta) as a maintenance treatment in adult patients with moderate to severe chronic obstructive
pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting
beta2-agonist.
On 18 September 2017 GSK and Innoviva, Inc. announced US Food and Drug Administration (FDA) approved Trelegy Ellipta for the
long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and
reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving
umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Trelegy Ellipta is not indicated for relief of
acute bronchospasm or the treatment of asthma.
Global regulatory filings with the IMPACT study are expected to commence in the second quarter of 2018 for consideration of
expansion of the indicated patient population.
About IMPACT
The InforMing the PAthway of COPD Treatment (IMPACT) study was a randomised, double-blind, 3-arm parallel group, multicentre study evaluating FF/UMEC/VI
(100mcg/62.5mcg/25mcg) versus UMEC/VI (62.5mcg/25mcg) and FF/VI (100mcg/25mcg), all given once daily via the ELLIPTA dry powder
inhaler. The total duration of the study was approximately 55 weeks consisting of a 2-week run-in period, 52-week treatment period
and a 1-week safety follow-up period. Patients had moderate to very severe symptomatic COPD with a history of exacerbation in the
prior 12 months. In the study, 10,355 patients were treated in over 1,035 study centres globally.
The primary efficacy endpoint was the annual rate of on-treatment moderate and severe exacerbations. This was compared for
FF/UMEC/VI versus UMEC/VI and, FF/UMEC/VI versus FF/VI. Other endpoints included lung function and patient reported outcomes,
including health related quality of life measures.
About COPD
COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both and limits airflow to the lungs, interfering
with normal breathing. It is thought to affect 384 million people worldwide. 1
For people living with COPD the inability to breathe normally and worsening of their symptoms can consume their daily life and
make simple activities, like walking upstairs, an everyday struggle.
Long-term exposure to lung 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. 2
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 our work.
About Trelegy Ellipta
Trelegy Ellipta is the first once-daily single inhaler triple therapy approved in the US for the long-term, once-daily, maintenance
treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on
a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom
additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose
combination of fluticasone furoate and vilanterol. Trelegy Ellipta is not indicated for relief of acute bronchospasm or the
treatment of asthma.
Trelegy contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and
vilanterol, a long-acting beta2-adrenergic agonist, in a single inhaler, the Ellipta.
Full US Prescribing Information, including BOXED WARNING and Medication Guide is available at: us.gsk.com .
Important Safety Information (ISI) for Trelegy Ellipta
The following ISI is based on the Highlights section of the US Prescribing Information for Trelegy Ellipta. Please consult the full
Prescribing Information for all the labelled safety information for Trelegy Ellipta.
Long-acting beta 2 -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 patents 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 – 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.
RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of
companies.
Innoviva – Innoviva is focused on bringing compelling new 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®/BREO®
ELLIPTA® and ANORO® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the
agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO®
ELLIPTA®, ANORO® ELLIPTA®. In addition, Innoviva retains a 15 percent economic interest in future
payments made by GSK for earlier-stage programs partnered with Theravance Biopharma, Inc., including the closed triple combination
therapy for COPD. For more information, please visit Innoviva's website at www.inva.com.
GSK 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 2016.
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, 2016 and Quarterly Report on Form 10-Q for the quarter ended June 30,
2017, which are on file with the U.S. Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. 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).
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References
- Global Initiative for Chronic Obstructive Lung Disease Global Initiative for Chronic Obstructive Lung
Disease. 2017. Pocket guide to COPD diagnosis, management, and prevention. Available at: http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf
- Diagnosis of COPD. World Health Organisation. Available at: http://www.who.int/respiratory/copd/diagnosis/en/ ]
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