Myovant Sciences Announces European Commission Approval for ORGOVYX® (relugolix) for the Treatment of Advanced Hormone-Sensitive Prostate Cancer

Rhea-AI Summary

The European Commission has approved ORGOVYX® (relugolix, 120 mg) for the treatment of advanced hormone-sensitive prostate cancer, marking its first oral androgen deprivation therapy in Europe. This approval spans all 27 EU member states and additional countries like Iceland and Norway. Myovant anticipates announcing a commercialization partner soon, ahead of market launches. ORGOVYX® demonstrated superior testosterone suppression in the Phase 3 HERO study compared to leuprolide acetate and offers a new treatment option to improve patient care.

Positive

• Approval of ORGOVYX® in Europe for advanced hormone-sensitive prostate cancer.
• Demonstrated superior efficacy in testosterone suppression compared to leuprolide in Phase 3 HERO study.
• Positive market potential with anticipated commercialization partner announcement soon.

Negative

• None.

• ORGOVYX^® is the first and only oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in Europe
• Myovant expects to secure European commercialization partner ahead of anticipated launches

BASEL, Switzerland, April 29, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) today announced that the European Commission (EC) has approved the marketing authorisation application for ORGOVYX^® (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The approval is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.

“Now for the first time, patients in Europe have the ability to rapidly reduce testosterone without hormonal flare in a convenient oral form,” said Juan Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences, Inc. “This approval provides a valuable new treatment option for men with advanced hormone-sensitive prostate cancer in Europe and has the potential to change the standard of care over time.”

“We’ve made significant progress in securing a business partner for the commercialization of ORGOVYX^® in Europe. We’ve had interest from multiple parties and anticipate an announcement in the upcoming weeks, in advance of the anticipated launches in European markets,” said David Marek, Chief Executive Officer, Myovant Sciences, Inc.

This approval was supported by data from the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix. The study compared relugolix to leuprolide in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. ORGOVYX^® received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with advanced prostate cancer in December 2020.

In the HERO study, ORGOVYX^® met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% (95% confidence interval [CI]: 94.9-97.9) of men, compared with 88.8% (95% CI: 84.6-91.8) of men receiving leuprolide acetate injections, the current standard of care. ORGOVYX^® also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone to castrate levels at Day 4 and Day 15 (56% versus 0% and 99% versus 12%, respectively) and profound suppression of testosterone (< 20 ng/dL) at Day 15 (78% versus 1%). The most frequent adverse events reported in at least 10% of men in the ORGOVYX^® group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea. The HERO data were previously presented in an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, with simultaneous publication in The New England Journal of Medicine.

About Prostate Cancer
Prostate cancer is a leading cause of death in the European Union with about 65,200 men having died from the disease in 2016. The standardized death rate from prostate cancer stood at 38 deaths per 100,000 male inhabitants according to Eurostat.

Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism- of-action limitations, including the potentially detrimental initial surge 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.

About ORGOVYX^® (relugolix)
ORGOVYX^® (relugolix, 120 mg) is indicated in Europe for the treatment of adult patients with advanced hormone-sensitive prostate cancer. As a GnRH antagonist, ORGOVYX^® blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

About Myovant Sciences 
Myovant Sciences is a healthcare company focused on redefining care through differentiated solutions in high unmet need areas within women’s health and hormone-sensitive oncology. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. The company also has received regulatory approvals by the European Commission (EC) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. The company has a supplemental New Drug Application in endometriosis-associated pain pending with the U.S. FDA. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant  on Twitter and LinkedIn. 

Myovant Sciences’ Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including: statements regarding Myovant’s aspiration to redefine care through differentiated solutions in high unmet need areas within women’s health and hormone-sensitive oncology; the expectations for the potential commercialization and launch of ORGOVYX^® for adult patients with hormone-sensitive advanced prostate cancer in Europe; Myovant’s expectations regarding partnership opportunities with multiple interested parties for European commercialization of relugolix in advanced hormone-sensitive prostate cancer, including the timing of any potential agreement with a partner by the anticipated launch of ORGOVYX^® in European markets; and Myovant’s expectations regarding the potential benefits of ORGOVYX^® and its potential to become the new standard of care in advanced hormone-sensitive prostate cancer.

For a further discussion of factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations, see 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’ Quarterly Report on Form 10-Q filed on January 26, 2022, 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.

Myovant Sciences Investor Contact:
Uneek Mehra
Chief Financial and Business Officer
Myovant Sciences, Inc.
investors@myovant.com

Myovant Sciences Media Contact:
Noelle Cloud Dugan
Vice President, Corporate Communications and Public Affairs
Myovant Sciences, Inc.
Noelle.clouddugan@myovant.com

 

FAQ

What is the significance of the European Commission's approval of MYOV's ORGOVYX®?

The approval allows Myovant to offer the first oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in Europe, enhancing treatment options for patients.

When can we expect the commercialization of MYOV's ORGOVYX® in Europe?

Myovant expects to secure a commercialization partner soon, with anticipated launches in European markets to follow.

What were the key findings from the HERO study for MYOV's ORGOVYX®?

The HERO study showed that ORGOVYX® achieved sustained testosterone suppression (<50 ng/dL) in 96.7% of men, surpassing the 88.8% success rate of leuprolide acetate.