LONDON and NEW YORK, May 29,
2020 /PRNewswire/ -- Sumitovant Biopharma Ltd. announced
that Myovant Sciences (NYSE: MYOV), a healthcare company focused on
redefining care for women and for men, and one of five healthcare
companies in the Sumitovant family of companies, today had
additional results from its Phase 3 HERO study of once-daily, oral
relugolix (120 mg) in men with advanced prostate cancer presented
orally at the American Society of Clinical Oncology (ASCO)'s ASCO20
Virtual Scientific Program and simultaneously published 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.
About Sumitovant Biopharma Ltd.
Sumitovant is a global
biopharmaceutical company with offices in New York City and London. Sumitovant is the majority shareholder
of Myovant and Urovant, and wholly owns Enzyvant, Spirovant, and
Altavant. Sumitovant's promising pipeline is comprised of
early-through late-stage investigational medicines across a range
of disease areas targeting high unmet need. Sumitovant is a wholly
owned subsidiary of Sumitomo Dainippon Pharma. For further
information about Sumitovant, please
visit https://www.sumitovant.com. Follow Sumitovant on
LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo
Dainippon Pharma is among the top-ten listed pharmaceutical
companies in Japan, operating
globally in major pharmaceutical markets, including Japan, the U.S., China, and the European Union. Sumitomo
Dainippon Pharma is based on the merger in 2005 between Dainippon
Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd.
Today, Sumitomo Dainippon Pharma has more than 6,000 employees
worldwide. Additional information about Sumitomo Dainippon Pharma
is available through its corporate website at
https://www.ds-pharma.com.
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.
Media Contacts:
Sumitovant Biopharma Media Contact
Mary Stutts
SVP, Corporate Relations
media@sumitovant.com
Myovant Sciences Investor Contact:
Frank Karbe
President and Chief Financial Officer
Myovant Sciences, Inc.
investors@myovant.com
Myovant Sciences Media Contact:
Albert Liao
Director, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com
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