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
LONDON, UK I September 20, 2017 I 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.
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.
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/]
SOURCE: Innoviva
Post Views: 21
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
LONDON, UK I September 20, 2017 I 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.
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.
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/]
SOURCE: Innoviva
Post Views: 21
