GlaxoSmithKline plc GSK and
Theravance, Inc. THRX today announced positive results from
two phase III studies, which showed that patients with chronic
obstructive pulmonary disease (COPD) who received the
anticholinergic, Incruse(TM) Ellipta(R) (umeclidinium (UMEC)
62.5mcg), or umeclidinium 125mcg (an unlicensed dose) in addition to
Relvar(R)/Breo(R) Ellipta(R) (fluticasone furoate/vilanterol,
"FF/VI"), an inhaled corticosteroid / long-acting beta2-agonist
combination, achieved an additional improvement in lung function
(FEV1) compared to patients receiving FF/VI plus placebo.
The studies showed that for the primary endpoint of trough FEV1 at
Day 85, the addition of UMEC 62.5mcg or UMEC 125mcg to FF/VI
100/25mcg resulted in a statistically significant improvement in lung
function when compared with FF/VI 100/25mcg plus placebo in patients
with COPD.
Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK said:
"These data are an important addition to the evidence base supporting
the efficacy and safety of Incruse. These studies are also the first
to investigate the combined effect of two of the newest medicines
from our respiratory portfolio, both of which provide 24 hour
efficacy. We will continue to progress our research to expand our
understanding of how the combined use of these medicines may provide
physicians with another treatment approach to meet the individual
needs of their patients."
"We are pleased with the positive data from these two studies
evaluating an open triple therapy, Incruse added to Relvar/Breo
Ellipta," said Rick E Winningham, Chief Executive Officer,
Theravance. "With the data reported today, we have further
strengthened our understanding of Relvar/Breo Ellipta."
Study designs:
Both studies (200109 and 200110) were 12-week
multicentre, randomised, double-blind placebo-controlled studies.
1238 patients with an established clinical history of COPD and an
FEV1 of d70%, were randomised and treated in the studies.
Eligible patients were randomised 1:1:1 to receive UMEC 62.5mcg, UMEC
125mcg or placebo added to open-label FF/VI 100/25mcg. All treatments
were administered once daily in the dry powder inhaler (DPI),
Ellipta(R).
The primary endpoint for both studies was trough forced expiratory
volume in one second (FEV1) on Day 85.
Studies results:
200109: For the pre-specified primary endpoint of
trough FEV1 (Day 85), compared with placebo added to FF/VI 100/25mcg,
both UMEC 62.5mcg and UMEC 125mcg added to FF/VI 100/25mcg, produced
statistically significant improvements (UMEC 62.5mcg plus FF/VI
100/25 mcg: 124mL difference versus placebo plus FF/VI 100/25mcg;
UMEC 125mcg plus FF/VI 100/25 mcg: 128mL difference versus placebo
plus FF/VI 100/25mcg, both p < 0.001).
Incidence of on-treatment adverse events (AEs) were 36% UMEC 62.5mcg
+ FF/VI 100/25mcg, 39% UMEC 125mcg + FF/VI 100/25mcg, 35% placebo +
FF/VI 100/25 mcg. The most frequently reported adverse events
(greater than or equal to 3% in any treatment group) were headache,
nasopharyngitis, back pain, dysgeusia (an abnormal taste or change in
taste), cough, diarrhoea and influenza. The incidence of any
cardiovascular adverse events of special interest was 2% UMEC 62.5mcg
+ FF/VI 100/25mcg, 1% UMEC 125mcg + FF/VI 100/25mcg, 3% placebo +
FF/VI 100/25mcg. The incidence of pneumonia in the UMEC 125mcg +
FF/VI 100/25mcg and the placebo + FF/VI 100/25mcg groups was 1%.
There were no reported cases of pneumonia in the UMEC 62.5mcg + FF/VI
100/25mcg group. One death was reported in the placebo + FF/VI
100/25mcg group and was deemed non drug related by the investigator.
There were no deaths reported in the UMEC + FF/VI 100/25mcg treatment
groups.
200110: For the pre-specified primary endpoint of Trough FEV1 (Day
85), compared with placebo added to FF/VI 100/25mcg, UMEC 62.5mcg and
UMEC 125mcg added to FF/VI 100/25mcg, produced statistically
significant improvements (UMEC 62.5mcg plus FF/VI 100/25 mcg: 122mL
difference versus placebo plus FF/VI 100/25mcg; UMEC 125 mcg plus
FF/VI 100/25 mcg: 111mL difference versus placebo plus FF/VI
100/25mcg, both p < 0.001).
Incidence of on-treatment adverse events (AEs) were 33% UMEC 62.5mcg
+ FF/VI 100/25mcg, 30% UMEC 125mcg + FF/VI 100/25mcg, 39% placebo +
FF/VI 100/25mcg. The most frequently reported adverse events (greater
than or equal to 3% in any treatment group) were nasopharyngitis,
headache and back pain. The incidence of any cardiovascular adverse
events of special interest was similar across treatment groups ( < 1%
UMEC 62.5mcg + FF/VI 100/25mcg, 1% UMEC 125mcg + FF/VI 100/25mcg, 3%
placebo + FF/VI 100/25mcg). The incidence of pneumonia was the same (
< 1%) in all treatment groups. Four deaths were reported in the
placebo + FF/VI 100/25mcg group and one death was reported in the
UMEC 62.5mcg + FF/VI 100/25mcg treatment group. All deaths were
deemed non drug related by the investigator.
Umeclidinium 62.5mcg inhalation powder, under the brand name Incruse
Ellipta, is only approved for use in the US, Canada and Europe for
COPD. It is not approved anywhere else in the world. Umeclidinium
125mcg is not an approved dose anywhere in the world.
The full results of these studies will be posted onto
clinicaltrials.gov and presented at a future scientific meeting.
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