GlaxoSmithKline plc : GSK presents phase III results for eltrombopag in hepatitis C virus related thrombocytopenia
11/07/2011 | 06:40pm
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Issued: Monday 07 November 2011, London UK
Full results from ENABLE 1 and initial data from ENABLE 2
presented at the 62nd Annual Meeting of the American
Association for the Study of Liver Diseases
Findings from the ENABLE clinical trials, which evaluated the
ability of eltrombopag to raise and maintain platelet levels
in patients with chronic hepatitis C virus (HCV) infection
and low platelet levels that would preclude initiation of
interferon-based antiviral therapy, were presented today at
the 62nd Annual Meeting of the American Association for the
Study of Liver Diseases in San Francisco. Use of
eltrombopag to treat thrombocytopenia in patients with
chronic HCV infection is not approved anywhere in the
world.
In ENABLE 1, patients who received eltrombopag along with
Pegasys® (peginterferon alfa-2a) and ribavirin antiviral
therapy achieved a statistically significant improvement in
the primary endpoint of sustained virologic response (SVR), a
clinically validated endpoint that means there is no
detectable hepatitis C virus in a patient's blood. 23%
of patients in the eltrombopag group achieved SVR compared to
14% of patients receiving placebo (p=0.0064). Serious adverse
events were reported in 20% of eltrombopag and 15% of placebo
patients. During the entire study period death occurred
in 2% of patients in the eltrombopag and 3% in the placebo
group. Thromboembolic events were reported in 2% of
eltrombopag patients and 2% of placebo patients.
Elevations in liver enzymes were similar in both
groups. Events consistent with worsening of liver
function were reported in 13% of eltrombopag patients and 8%
of placebo patients.
The ENABLE 1 trial enrolled 716 adults with HCV and platelet
levels less than 75,000/µL into an open label eltrombopag
treatment period. Those who achieved platelet levels greater
than or equal to 90,000/µL were randomly assigned on a 2 to 1
basis to eltrombopag or placebo plus peginterferon alfa-2a
and ribavirin.
Initial data from ENABLE 2, a randomised Phase III trial of
eltrombopag plus PEG-Intron® (peginterferon alfa-2b) and
ribavirin were also presented. The ENABLE 2 trial met
its primary endpoint of improved SVR, with 19% of eltrombopag
patients and 13% of placebo patients achieving SVR
(p=0.0202). Serious adverse events were reported in 20%
of eltrombopag and 15% of placebo patients. Death occurred in
4% of patients in the eltrombopag and 2% of placebo group.
Thromboembolic events were reported in 4% of eltrombopag
patients and less than 1% of placebo patients.
Elevations in liver enzymes were similar in both groups.
Events consistent with worsening of liver function were
reported in 15% of eltrombopag patients and 8% placebo
patients.
The ENABLE 2 trial enrolled 805 adults with HCV and platelet
levels less than 75,000/µL into an open label eltrombopag
treatment period and those who achieved platelet levels
greater than or equal to 100,000/µL were randomly assigned on
a 2 to 1 basis to eltrombopag or placebo plus peginterferon
alfa-2b and ribavirin. Analyses are ongoing and full
study results will be submitted for presentation at a future
medical meeting.
"The ENABLE trials provide insight into a population that has
generally been excluded from clinical trials because they are
unable to initiate interferon therapy." said Rafael Amado,
Senior Vice President, Oncology Development "We will fully
examine the efficacy and safety findings of both studies to
evaluate the overall clinical benefit to these patients."
About eltrombopag (PROMACTA®/Revolade®)
Eltrombopag is in development as a potential treatment for
thrombocytopenia associated with chronic hepatitis C virus
infection. It is subject to evaluation of the benefits and
risk by regulatory authorities before being made available
for use in this setting.
Eltrombopag, known by the brand name PROMACTA®/Revolade® is
approved in 78 countries around the world as a treatment for
thrombocytopenia in patients with chronic immune (idiopathic)
thrombocytopenic purpura (ITP).
In Europe, Revolade® is indicated for the treatment of
thrombocytopenia in splenectomised adult patients with
chronic ITP who are refractory to other treatments, such as
corticosteroids and immunoglobulins. Revolade may also be
considered as second-line treatment for adult
non
