Landmark IMPACT study published in NEJM shows significant benefits of Trelegy for high risk patients with COPD

GSK recently announced the publication in the New England Journal of Medicine (NEJM) of the landmark IMPACT study, providing the evidence that high risk patients with chronic obstructive pulmonary disease (COPD) with a history of exacerbation can benefit from Trelegy including inhaled corticosteroids (“ICS”).

GSK recently announced the publication in the New England Journal of Medicine (NEJM) of the landmark IMPACT study, providing the evidence that high risk patients with chronic obstructive pulmonary disease (COPD) with a history of exacerbation can benefit from Trelegy including inhaled corticosteroids (“ICS”).

The study is one of the biggest ever conducted in patients with 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.

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]

 

As part of the ‘in China, with China, for China’ strategy, GSK China has:

  • Announced Anoro Ellipta, a new once-daily dual bronchodilators treatment for COPD was approved in March 2018.
  • Announced innovative antiretroviral Single Tablet Regimen Triumeq was officially launched in January 2018.
  • Supported the launch of “New Respiration and Frequent Care” online management platform for asthma patients in December 2017.
  • Supported the launch of the UK-China Health and Economy Partnership in November 2017.
  • Supported the launch of "Happy Breath", COPD Tiered Diagnosis and Treatment Project across China in November 2017.
  • Announced Flixotide Nebules received approval for the treatment of children asthma in September 2017.
  • Announced partnership with Ali Health to launch innovative online service platform to improve adult vaccination consultation experience in Aug 2017.
  • Announced innovative antiretroviral Single Tablet Regimen Triumeq received approval in China in Aug 2017.
  • Announced Cervarix, first vaccine for cervical cancer prevention in mainland China, was officially launched in July 2017.
  • Announced the collaboration programme to aid hepatitis prevention and treatment in poverty-stricken areas of the western region in July 2017.
  • Announced Seroxat CR and Tykerb on the list of reimbursed drugs as results of the national health insurance negotiations in July 2017.
  • Announced a strategic partnership with academia to co-develop health big-data system and upgrade the management of respiratory diseases in June 2017.
  • Aided the National Preventive Vaccination Services and Management Training Programme, helmed by the Chinese Preventive Medicine Association under the guidance of the National Health and Family Planning Commission, with the support of the China Centre for Disease Control and Prevention that officially kicked off in June 2017.
  • Announced Viread, Arixtra, Requip and Mivacron included in the “2017 National Reimbursement Drug List” in Mar 2017.

 

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.

 

GSK commitment to China

We are a science-led global healthcare company. We research, develop and manufacture a wide range of medicines, vaccines and consumer healthcare products. People are at the heart of what we do. We strive to bring high quality, high performing products to everyone who needs them. Creating innovative products and improving access to them is critical to our mission, allowing us to help build stronger, healthier communities. In China, and around the world, we are on a mission to help people do more, feel better, live longer. We are in China, with China, for China, and our commitment remains unwavering.

 

GSK enquiries:

Chloe Yao      chloe.x.yao@gsk.com        (China)

Susan Song   susan.s.song@gsk.com      (China)

 

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:

[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.