TIDMGSK
RNS Number : 5243Y
GlaxoSmithKline PLC
06 December 2017
Issued: Wednesday 6 December 2017, London UK
New data supports the safety and efficacy of GSK's Shingrix in
preventing shingles in autologous haematopoietic stem cell
transplant patients
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that new
data from a Phase III clinical study supports the safety and
efficacy of Shingrix ((Zoster Vaccine Recombinant, Adjuvanted) in
preventing shingles (herpes zoster) when given to adults 18 years
and above shortly after undergoing autologous haematopoietic stem
cell transplant (auHSCT). Shingrix is a non-live, recombinant
adjuvanted subunit vaccine given intramuscularly in two doses.
The ZOE-HSCT study succeeded in its primary objective by
demonstrating an efficacy of 68.17% [95%CI: 55.56 - 77.53] against
shingles in subjects above 18 years of age after receiving an
autologous haematopoietic stem cell transplant. In subjects aged 50
and above, the efficacy was similar, 67.34% [95% CI: 52.60 -
77.89]. The vaccine reduced overall complications linked to
shingles episodes by 77.76% [95% CI: 19.05% - 95.93%]. Vaccine
efficacy for the prevention of post-herpetic neuralgia, a form of
chronic nerve pain and the most common complication associated with
shingles, was 89.27% [95% CI: 22.54-99.76]. No safety issues
related to the vaccine were detected during the study.
"The immune systems of these stem cell transplant recipients is
substantially weakened compared to the general older adult
populations studied in other Shingrix efficacy trials," Emmanuel
Hanon, Senior Vice President and Head of Vaccines R&D for GSK
said. "This puts them at much higher risk for viral diseases like
shingles and, at the same time, makes developing an effective
vaccine to help protect them more challenging."
"Today's results, demonstrating the vaccine's ability to help
prevent shingles and its complications with just two doses, may
provide a much-needed benefit to these patients considering the
high incidence and burden of disease they face," he said.
Shingrix is the first shingles vaccine to combine a non-live
antigen, to trigger a targeted immune response, with a specifically
designed adjuvant to generate a strong and sustained immune
response.
GSK is evaluating these results together with those of other
Phase III studies in immune-compromised patient populations. All
these data will be shared and discussed with regulatory as well as
public health agencies with the objective of best informing health
care providers on the use of Shingrix in those patients with
greatest medical need.
Shingrix is now approved in Canada and US for the prevention of
herpes zoster in adults aged 50 years and above. Regulatory reviews
are currently underway in the European Union, Australia and
Japan.
About the ZOE-HSCT Study
ZOE-HSCT was a Phase III clinical study to evaluate the
efficacy, safety and immunogenicity of a two-dose course of
Shingrix for prevention of shingles (herpes zoster) when given to
adults 18 years and above with the first dose administered 50-70
days after they had undergone autologous haematopoietic stem cell
transplant (auHSCT). Study participants were randomized 1:1 to
receive either Shingrix or placebo.
The study started in July 2012 and enrolled 1846 subjects in 28
countries worldwide spanning the North and South America, Europe,
Africa, Asia and Oceania.
The safety profile of the vaccine was found to be clinically
acceptable in this study. Overall, the proportion of severe adverse
events (SAEs), fatal SAEs, potential immune-mediated diseases
(pIMDs) and relapses (of the underlying disease) was similar
between groups. Observations regarding reactogenicity were in line
with the observations in previous studies.
This is the first time that Shingrix efficacy has been evaluated
in immune-compromised patients such as those who have received
auHSCT and who are at higher risk of developing shingles and its
complications. These data complement the available efficacy results
from ZOE-50 and ZOE-70 generated in adults aged 50 years and
older.
Previously the only available shingles vaccine was live
attenuated and therefore contra-indicated for those with weakened
immunity. Developing an effective vaccine for these patients was an
area of unmet medical need.
About auHSCT
Hematopoietic stem cells consistently replicate and ensure the
production of new blood cells. They are located in the red bone
marrow which is contained in the core of most bones.
Hematopoietic stem cell transplantation (HSCT) in adults is most
commonly performed as part of the treatment for blood cancer. It
requires the extraction of haematopoietic stem cells, usually
collected from the bone marrow or blood, to be thereafter
transfused into the patients' bloodstream where they induce normal
blood cell production. The transplant is called 'autologous' when
the patient's own cells are used.
In preparation for the transplant, the patients are treated with
high-dose chemotherapy, with or without radiotherapy, with the
intention of eradicating the patient's malignant cell population at
the cost of partial or complete bone marrow ablation (destruction
of patient's bone marrow's ability to grow new blood cells).
For this reason, since the recipient's cellular immune system is
usually destroyed by the radiation or chemotherapy before
transplantation, HSCT recipients are at high risk from viral
infections like shingles, and its complications.[i]
Over 11,000 people in the US undergo auHSCT each year.[ii]
About Shingles
Shingles is caused by the reactivation of the varicella zoster
virus (VZV), the same virus that causes chickenpox.[iii] Nearly all
adults have the VZV dormant in their nervous system, which can
reactivate with advancing age[iv] or when a person is immune
compromised due to certain diseases (such as cancer or HIV) or is
receiving immune-suppressive treatments (such as chemotherapy).
Shingles typically presents as a painful, itchy rash that
develops on one side of the body and can last for two to four
weeks. The pain associated with shingles is often described as
burning, shooting or stabbing.[v] ([vi]) Even once the rash is
gone, a person can experience postherpetic neuralgia (PHN), pain
lasting from at least three months up to several years. PHN is the
most common complication of shingles, occurring in 10 to 18 percent
of all shingles cases.[vii]
There are an estimated one million cases of shingles in the
United States each year.[viii] More than 99 percent of those over
50 years old are infected with VZV, and one in three Americans will
develop shingles in their lifetime.
About Shingrix
Shingrix is a non-live, recombinant adjuvanted subunit vaccine
approved in the United States and Canada to help prevent shingles
(herpes zoster) in people aged 50 years or older. Shingrix is not
contraindicated in immune-compromised people in this age
population.
It combines an antigen, glycoprotein E, and an adjuvant system,
AS01(B) , intended to generate a strong and long-lasting immune
response that can help overcome the decline in immunity as people
age as well as weakened immunity due to disease or
immune-suppressive treatments.
Full US Prescribing Information is available here:
https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm581491.htm
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 enquiries:
Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Spencer +1 215 751 (Philadelphia)
3335
Gwynne Oosterbaan +1 215 751 (Philadelphia)
7468
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
enquiries: 8047 5194
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
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.
Registered in England & Wales:
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TW8 9GS
[i] Rogers JE et al. Onset and complications of varicella zoster
reactivation in the autologous haematopoietic cell transplant
population. Transpl Infect Dis. 2011; 13:480-4
[ii]https://bloodcell.transplant.hrsa.gov/research/transplant_data/transplant_activity_report/index.html#numbers
[iii] Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee
on Immunization Practices (ACIP), Centers for Disease Control and
Prevention (CDC). Prevention of herpes zoster: recommendations of
the Advisory Committee on Immunization Practices (ACIP). MMWR
Recomm Rep. 2008 Jun;57(RR-5):1-30.
[iv] Gnann et al. Clinical practice. Herpes zoster. N Eng J Med.
2002;347(5):340-6.
[v] Cunningham et al. Efficacy of the herpes zoster subunit
vaccine in adults 70 years of age or older. N Engl J Med.
2016;375:1019-32.
[vi] Yawn et al. Health care utilization and cost burden of
herpes zoster in a community population. Mayo Clin Proc.
2009;84(9):787-94.
[vii] Cohen et al. Herpes Zoster. N Eng J Med.
2013;369:255-63.
[viii] Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory
Committee on Immunization Practices (ACIP), Centers for Disease
Control and Prevention (CDC). Prevention of herpes zoster:
recommendations of the Advisory Committee on Immunization Practices
(ACIP). MMWR Recomm Rep. 2008 Jun;57(RR-5):1-30.
This information is provided by RNS
The company news service from the London Stock Exchange
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