Phase 3 VICTORIA Trial is the First
Contemporary Outcomes Study Focused Exclusively on a Chronic Heart
Failure Patient Population Following a Worsening Event
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced the presentation of results from the
VICTORIA trial, a Phase 3 study evaluating the efficacy and safety
of its investigational drug vericiguat, an orally administered
soluble guanylate cyclase (sGC) stimulator being developed to treat
patients with heart failure with reduced ejection fraction and
following a worsening event. VICTORIA is the first contemporary
outcomes study focused exclusively on symptomatic chronic heart
failure patients (ejection fraction <45%) following a worsening
event. Vericiguat is being jointly developed with Bayer AG.
Patients enrolled in VICTORIA were at high risk of
hospitalization and cardiovascular death following a recent heart
failure decompensation. Vericiguat, when given in combination with
available heart failure therapies, met the primary efficacy
endpoint of reducing the risk for the composite endpoint of heart
failure hospitalization or cardiovascular death in patients with
worsening chronic heart failure with reduced ejection fraction
(HFrEF), compared to placebo. A hazard ratio of 0.90 (95% CI
0.82-0.98) in this high risk population translated into a
clinically relevant 4.2/100 patient-years absolute reduction in
event rate. Based on this absolute risk reduction, the number
needed to treat with vericiguat for one year to prevent a primary
outcome event is approximately 24 patients.
“For this group of chronic heart failure patients at high risk
for future events, vericiguat has the potential to provide a
significant addition to usual guideline-based treatment,” said Paul
W. Armstrong, M.D., cardiologist and Distinguished University
Professor of Medicine at the Canadian VIGOUR Centre, University of
Alberta, the study’s lead author. “We are pleased with the observed
absolute risk reduction and are hopeful that this result may open
up a new avenue for appropriate patients and a possible path for
future discovery in cardiovascular heart disease.”
“VICTORIA builds on Merck’s strong legacy of conducting large
cardiovascular outcomes studies designed to answer meaningful
questions. By enrolling patients receiving heart failure therapy
following intervention for a worsening event such as
rehospitalization or urgent outpatient treatment, VICTORIA was
designed to study a serious medical problem not studied in any
other recent heart failure outcomes study,” said Dr. Roy Baynes,
senior vice president and head of global clinical development,
chief medical officer, Merck Research Laboratories. “In the
VICTORIA trial, vericiguat met its primary endpoint, achieving a
significant reduction in the risk of cardiovascular death and
hospitalization for heart failure in these patients overall when
given in combination with available heart failure therapies.”
The safety profile of vericiguat was consistent with that
reported in previous studies.
These results were presented today at the virtual American
College of Cardiology’s 69th Annual Scientific Session Together
With World Congress of Cardiology (ACC.20/WCC) and published in The
New England Journal of Medicine.
Merck and Bayer plan to share VICTORIA data with regulatory
authorities worldwide.
Study design and additional data from the VICTORIA trial
(NCT02861534)
VICTORIA is a randomized, placebo-controlled, parallel-group,
multi-center, double-blind, Phase 3 study of vericiguat versus
placebo when given in combination with available heart failure
therapies in patients with worsening chronic heart failure (New
York Heart Association class II-IV), a reduced left ventricular
ejection fraction of <45% within 12 months prior to
randomization, and elevated natriuretic peptide levels (determined
by sites) within 30 days prior to randomization. For patients in
sinus rhythm, plasma B-type natriuretic peptide (BNP) levels ≥300
pg/ml and NT-proBNP levels ≥1000 pg/ml were required. For those in
atrial fibrillation, BNP levels ≥500 pg/ml and NT-proBNP ≥1600
pg/ml were required. Patients were required to have evidence of
worsening heart failure and were classified into three cohorts
based on the timing of their symptomatic worsening: <3 months;
3–6 months after hospitalization; and those receiving intravenous
diuretic therapy, without hospitalization, within the prior 3
months.
The primary endpoint of the study is the composite of time to
first occurrence of heart failure hospitalization or cardiovascular
death. Secondary endpoints include time to occurrence of
cardiovascular death, time to first occurrence of heart failure
hospitalization, time to total heart failure hospitalizations
(including first and recurrent events), time to the composite of
all-cause mortality or heart failure hospitalization, and time to
all-cause mortality.
The study enrolled a total of 5,050 patients who were randomized
to receive either vericiguat once daily (titrated up to 10 mg)
(n=2,526) or placebo (n=2,524) when given in combination with
available heart failure therapies. The study, which was
co-sponsored by Merck and Bayer, was conducted in collaboration
with the Canadian VIGOUR Centre and the Duke Clinical Research
Institute at more than 600 centers in 42 countries.
Over a median of 10.8 months, the incidence of cardiovascular
death or heart failure-related hospitalization occurred in 897
(35.5%) patients receiving vericiguat and 972 (38.5%) receiving
placebo (HR 0.90; 95% CI 0.82–0.98; P=0.019). This effect was
consistent across the majority of pre-specified subgroups,
including patients receiving or not receiving sacubitril/valsartan.
Levels of NT-proBNP at baseline and age were shown to correlate
with the treatment effect. Here, the data suggest that the majority
of patients in the study with NT-proBNP in the lower quartile
ranges and those under 75 years of age may have achieved a greater
benefit.
Secondary Outcome Measure
Vericiguat % (#)
Placebo % (#)
Hazard ratio
Cardiovascular deaths
16.4%
414
17.5%
441
0.93; 95% CI 0.81–1.06;
P=0.269
HF-related hospitalization
27.4%
691
29.6%
747
0.90; 95% CI 0.81–1.00;
P=0.048
First and recurrent
hospitalizations
38.3 per 100 patient-years
1223
42.4 per 100 patient-years
1336
0.91; 95% CI 0.84–0.99;
P=0.023
All cause mortality
20.3%
512
21.2%
534
0.95; 95% CI 0.84–1.07;
P=0.377
All cause mortality or HF-related
hospitalization
37.9%
957
40.9%
1032
0.90; 95% CI 0.83–0.98;
P=0.021
The safety profile of vericiguat was consistent with that
reported in previous studies. The overall incidences of serious
adverse events were similar for the vericiguat (32.8%) and placebo
(34.8%) groups. Symptomatic hypotension (9.1% vs 7.9%) and syncope
(4.0% vs 3.5%) tended to be more common with vericiguat than
placebo, but the differences were not statistically significant.
Throughout the VICTORIA study, there were no significant
between-group differences for renal adverse events such as
hyperkalemia or decreases in eGFR. The vericiguat safety profile
was also similar when in combination with other therapies used in
heart failure patients.
About Heart Failure With Reduced Ejection Fraction
Heart failure with reduced ejection fraction (HFrEF), formerly
known as systolic heart failure, is characterized by the
compromised ability of the heart to eject blood sufficiently during
its contraction phase. In the U.S., 6.5 million people have heart
failure, and approximately 40-50% of these patients have HFrEF.
Annually, approximately 30% of patients with symptomatic chronic
heart failure will experience worsening of the disease, which is
marked by progressive symptoms and/or a recent heart failure event.
Approximately half of patients with worsening chronic HFrEF are
rehospitalized within 30 days of a worsening event, and an
estimated one in five patients with worsening chronic HFrEF will
die within two years.
About the Worldwide Collaboration Between Bayer and
Merck
Since October 2014, Bayer and Merck (known as MSD outside of the
United States and Canada) are in a worldwide collaboration in the
field of sGC modulators. The collaboration brings together two
leading companies that have stated their intent to fully evaluate
this therapeutic class in areas of unmet medical need. The
vericiguat program is being co-developed by Bayer and Merck.
About Merck
For more than 125 years, Merck, known as MSD outside of the
United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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