Myovant Sciences (NYSE: MYOV), a healthcare company focused on
redefining care for women and for men, today announced additional
results from its Phase 3 HERO study of once-daily, oral relugolix
(120 mg) in men with advanced prostate cancer in an oral
presentation at the American Society of Clinical Oncology (ASCO)’s
ASCO20 Virtual Scientific Program and simultaneous publication in
the New England Journal of Medicine (NEJM). The data expand on
earlier findings from the HERO study, demonstrating the superiority
of relugolix to leuprolide acetate across multiple endpoints, and
further show that treatment with relugolix was associated with a
lower risk of major adverse cardiovascular events compared to
leuprolide acetate.
Relugolix met the primary endpoint and demonstrated superiority
to leuprolide acetate across six key secondary endpoints, all with
p-values < 0.0001. In the primary endpoint responder analysis,
96.7% of men receiving once-daily, oral relugolix achieved
sustained testosterone suppression to castrate levels (< 50
ng/dL) through 48 weeks, compared to 88.8% of men treated with
leuprolide acetate.
Detailed secondary endpoint data, presented and published today,
showed notable differences in the rapid and profound suppression of
testosterone, PSA response, and testosterone recovery after
discontinuation of treatment. In the relugolix group, testosterone
suppression to less than 50 ng/dL was achieved in 56.0% of men by
Day 4 and 98.7% by Day 15, compared to 0.0% by Day 4 and 12.1% by
Day 15 for men in the leuprolide acetate group. Additionally, in
the relugolix group, profound testosterone suppression to less than
20 ng/dL was achieved in 78.4% of men at Day 15, compared to 1.0%
at Day 15 for men in the leuprolide acetate group. A higher
proportion of men in the relugolix group achieved a 50% reduction
in PSA by Day 15 and confirmed at Day 29 compared to those in the
leuprolide acetate group (79.4% vs. 19.8%, respectively). Within 90
days of treatment discontinuation, 54% of men in the relugolix
group achieved normal testosterone levels (≥ 280 ng/dL) with a mean
testosterone level of 288.4 ng/dL, compared to 3% of men in the
leuprolide acetate group with a mean testosterone level of 58.6
ng/dL.
“A faster effect in lowering testosterone for prostate cancer
patients can be clinically significant – likewise, a more rapid
testosterone recovery after stopping treatment, could potentially
improve a patient’s quality of life,” said Neal Shore, M.D.,
medical director of the Carolina Urologic Research Center, HERO
program steering committee member, presenter of the ASCO data, and
lead author on the NEJM paper. “Both of these findings could make a
meaningful difference in the treatment journey for men with
advanced prostate cancer.”
Men in the relugolix group had a 54% lower risk of major adverse
cardiovascular events compared to men in the leuprolide acetate
group (2.9% vs. 6.2%, respectively). Additionally, in men with a
history of these events, the relugolix group had 80% fewer major
adverse cardiovascular events reported compared to the leuprolide
acetate group (3.6% vs. 17.8%, respectively). More than 90% of men
in the HERO study had at least one cardiovascular risk factor,
including lifestyle risk factors such as tobacco use and obesity,
comorbidities such as diabetes and hypertension, and prior history
of a major adverse cardiovascular event.
“Cardiovascular disease is the leading cause of death in men
with prostate cancer,” said Dr. Shore. “An oral therapeutic option
with strong efficacy that also reduces cardiovascular risk compared
to that of conventional GnRH agonist therapy would be a critical
achievement for men with advanced prostate cancer.”
As previously reported, the incidence of adverse events in the
HERO study was comparable for relugolix and leuprolide acetate
groups (92.9% vs. 93.5%, respectively). The most frequently
reported adverse events, reported in at least 10% of men in the
relugolix group, were hot flashes, fatigue, constipation, mild to
moderate diarrhea, and arthralgia.
“Relugolix has the potential to be an important new treatment
option for men with prostate cancer and would represent significant
progress in our company’s commitment to redefine care for men,”
said Lynn Seely, M.D., chief executive officer of Myovant
Sciences. “We are grateful to have the opportunity to share these
additional data through presentation and publication in such
highly-respected venues as the American Society of Clinical
Oncology and the New England Journal of Medicine. We have already
submitted our New Drug Application to the FDA with the goal of
bringing this oral, once-daily potential treatment to men with
prostate cancer as expeditiously as possible, especially given the
current environment with the COVID-19 pandemic and the difficulties
and risks men face traveling to hospitals and clinics to receive
injections.”
Myovant submitted a New Drug Application (NDA) to the FDA for
relugolix in April 2020, which, if approved, would be the first and
only oral gonadotropin-releasing hormone (GnRH) receptor antagonist
treatment for men with advanced prostate cancer.
The ASCO presentation (#5602), “HERO phase III trial: Results
comparing relugolix, an oral GnRH receptor antagonist, versus
leuprolide acetate for advanced prostate cancer,” is available for
on-demand viewing.
Conference Call Myovant will hold a
conference call to discuss these data on Monday, June 1, 2020 at
8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. Myovant management
will be joined by Neal Shore, M.D. To participate in the live
conference call, please dial 1-800-532-3746 for domestic callers
and +1-470-495-9166 for international callers. A live webcast of
the conference call will also be available on the investor
relations page of Myovant’s website at investors.myovant.com and
will remain archived on Myovant’s website for at least 30 days.
About the Phase 3 HERO Program in Advanced Prostate
Cancer Myovant’s Phase 3 clinical program for advanced
prostate cancer consisted of a randomized, open-label,
parallel-group, multinational clinical study designed to evaluate
the safety and efficacy of relugolix in men with androgen-sensitive
advanced prostate cancer who required at least one year of
continuous androgen deprivation therapy. Men enrolled in the study
were randomized 2:1 to receive a single loading dose of relugolix
360 mg followed by relugolix 120 mg once daily, or to treatment
with leuprolide acetate 3-month depot injection, respectively.
Data from an additional key secondary endpoint, castration
resistance-free survival, are expected in the third quarter of
2020.
About Prostate Cancer Prostate cancer is the
second most prevalent form of cancer in men and the second leading
cause of death due to cancer in men in the U.S.
Cardiovascular mortality is the leading cause of death in men with
prostate cancer and accounts for 34% of deaths in men with prostate
cancer in the U.S. Approximately three million men in the
U.S. are currently living with prostate cancer, and
approximately 170,000 men are estimated to be newly diagnosed in
2019. Advanced prostate cancer is prostate cancer that has spread
or come back after treatment and may include men with biochemical
recurrence (rising PSA in the absence of metastatic
disease on imaging), locally advanced disease, or metastatic
disease. Treatment for advanced prostate cancer typically involves
androgen deprivation therapy, which reduces testosterone to very
low levels, commonly referred to as castrate levels. GnRH receptor
agonists, such as leuprolide acetate, or slow-release injections
are the current standard of care for androgen deprivation therapy.
However, GnRH receptor agonists may be associated with
mechanism-of-action limitations, including the potentially
detrimental initial rise in testosterone levels that can exacerbate
clinical symptoms, which is known as clinical or hormonal flare,
and delayed testosterone recovery after the drug is discontinued.
Approximately 200,000 men are treated with androgen deprivation
therapy with a GnRH agonist or antagonist each year.
About Relugolix Relugolix is a once-daily, oral
gonadotropin-releasing hormone (GnRH) receptor antagonist that
reduces testicular testosterone production, a hormone known to
stimulate the growth of prostate cancer, and ovarian estradiol
production, a hormone known to stimulate the growth of uterine
fibroids and endometriosis. Myovant is developing
relugolix as a monotherapy tablet (120 mg once daily) for men with
advanced prostate cancer. Myovant is also developing a
relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg,
and norethindrone acetate 0.5 mg) for women with uterine fibroids
and for women with endometriosis.
About Myovant Sciences Myovant
Sciences aspires to be the leading healthcare company focused
on redefining care for women and for men. The company’s lead
product candidate is relugolix, a once-daily, oral GnRH receptor
antagonist. The company has three late-stage clinical programs
for relugolix in uterine fibroids, endometriosis, and prostate
cancer. The company is also developing MVT-602, an oligopeptide
kisspeptin-1 receptor agonist, that has completed a Phase 2a study
for the treatment of female infertility as part of assisted
reproduction. Takeda Pharmaceuticals International AG, a
subsidiary of Takeda Pharmaceutical Company Limited, the originator
of relugolix, previously granted the company a worldwide
license to develop and commercialize relugolix
(excluding Japan and certain other Asian countries) and
an exclusive license to develop and commercialize MVT-602 in all
countries worldwide. Sumitovant Biopharma, Ltd., a wholly
owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is the
majority shareholder of Myovant. For more information, please
visit the company’s website at www.myovant.com.
Follow @Myovant on Twitter and LinkedIn.
Forward-Looking Statements This press-release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include all statements regarding Myovant Sciences’
intent, belief, or expectations regarding future events or results
and can be identified by words such as “anticipate,” “aspire,”
“believe,” “can,” “continue,” “could,” “estimate,” “expect,”
“intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,”
“potential,” “predict,” “project,” “should,” “to be,” “will,”
“would,” or the negative or plural of these words or other similar
expressions or variations, although not all forward-looking
statements contain these identifying words. In this press release,
forward-looking statements include, but are not limited to,
statements and quotes regarding Myovant Sciences’ aspirations to
become the leading healthcare company focused on redefining care
for women and for men; the characterizations of data from the HERO
study; the timing and likelihood of any approvals by the FDA; the
timing of data readout regarding the analysis of the secondary
endpoint of castration resistance-free survival expected in the
third quarter of 2020 and the commercial potential for once-daily,
oral relugolix for the treatment of men with advanced prostate
cancer. Myovant Sciences’ forward-looking statements are based on
management’s current expectations and beliefs and are subject to a
number of risks, uncertainties, assumptions and other factors known
and unknown that could cause actual results and the timing of
certain events to differ materially from future results expressed
or implied by the forward-looking statements. Myovant
Sciences cannot assure you that the events and circumstances
reflected in the forward-looking statements will be achieved or
occur and actual results could differ materially from those
expressed or implied by these forward-looking statements. Factors
that could materially affect Myovant Sciences’ operations and
future prospects or which could cause actual results to differ
materially from expectations include, but are not limited to the
risks and uncertainties listed in Myovant Sciences’ filings with
the United States Securities and Exchange
Commission (SEC), including under the heading “Risk Factors”
in Myovant Sciences’ Annual Report on Form 10-K filed on May
18, 2020, as such risk factors may be amended, supplemented or
superseded from time to time. These risks are not exhaustive. New
risk factors emerge from time to time and it is not possible for
Myovant Sciences’ management to predict all risk factors, nor
can Myovant Sciences assess the impact of all factors on
its business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those
contained in any forward-looking statements. You should not place
undue reliance on the forward-looking statements in this press
release, which speak only as of the date hereof, and, except as
required by law, Myovant Sciences undertakes no
obligation to update these forward-looking statements to reflect
events or circumstances after the date of such statements.
Investor Contact: Frank Karbe President and
Chief Financial Officer Myovant Sciences, Inc.
investors@myovant.com
Media Contact: Albert Liao Director,
Corporate Communications Myovant Sciences, Inc.
media@myovant.com
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