A Comparison of Orgovyx (Relugolix) vs Eligard (Leuprolide) on Cardiovascular Function and Biomarkers During Standard of Care Combined ADT (Androgen Deprivation Therapy)-Radiation for Prostate Cancer

This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.
Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:
1. Comprehensive cardiac and exercise testing before and after starting ADT
2. Completion of quality-of-life questionnaires at specific intervals during the study period
3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers

开始日期2024-08-12

申办/合作机构

Ohio State University Comprehensive Cancer Center

[+3]

NCT05765500 / Recruiting临床2期IIT

RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer

This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label.
The names of the study drugs involved in this study are:
Leuprolide (type of ADT)
Relugolix (type of ADT)

开始日期2024-02-12

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+3]

NCT05879913 / RecruitingN/AIIT

Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)

This is a randomized pilot study of Coronary CT Angiography (CCTA) for coronary atherosclerosis vs. Usual Care in patients with prostate cancer who are either planning to begin, or are currently taking androgen deprivation therapy (ADT) .

开始日期2023-12-15

申办/合作机构

Indiana University

[+3]

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项与 Myovant Sciences GmbH 相关的文献（医药）

2024-02-01·American journal of obstetrics and gynecology

Relugolix combination therapy in Black/African American women with symptomatic uterine fibroids: LIBERTY Long-Term Extension study

Article

作者: Marsh, Erica E ; Stewart, Elizabeth A ; Schulmann, Thierry ; Proehl, Sarah ; Madueke-Laveaux, O Sandra ; Zhu, Emily ; Lukes, Andrea S ; Al-Hendy, Ayman

BACKGROUND:

In the LIBERTY Long-Term Extension study, once-daily relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) substantially improved uterine fibroid-associated heavy menstrual bleeding throughout the 52-week treatment period in the overall study population.

OBJECTIVE:

Black or African American women typically experience a greater extent of disease and symptom burden of uterine fibroids vs other racial groups and have traditionally been underrepresented in clinical trials. This secondary analysis aimed to assess the efficacy and safety of relugolix combination therapy in the subgroup population of Black or African American women with uterine fibroids in the LIBERTY Long-Term Extension study.

STUDY DESIGN:

Black or African American premenopausal women (aged 18-50 years) with uterine fibroids and heavy menstrual bleeding who completed the 24-week randomized, placebo-controlled, double-blind LIBERTY 1 (identifier: NCT03049735) or LIBERTY 2 (identifier: NCT03103087) trials were eligible to enroll in the 28-week LIBERTY Long-Term Extension study (identifier: NCT03412890), in which all women received once-daily, open-label relugolix combination therapy. The primary endpoint of this subanalysis was the proportion of Black or African American treatment responders: women who achieved a menstrual blood loss volume of <80 mL and at least a 50% reduction in menstrual blood loss volume from the pivotal study baseline to the last 35 days of treatment by pivotal study randomized treatment group. The secondary outcomes included rates of amenorrhea and changes in symptom burden and quality of life.

RESULTS:

Overall, 241 of 477 women (50.5%) enrolled in the LIBERTY Long-Term Extension study self-identified as Black or African American. In Black or African American women receiving continuous relugolix combination therapy for up to 52 weeks, 58 of 70 women (82.9%; 95% confidence interval, 72.0%-90.8%) met the treatment responder criteria for reduction in heavy menstrual bleeding (primary endpoint). A substantial reduction in menstrual blood loss volume from the pivotal study baseline to week 52 was demonstrated (least squares mean percentage change: 85.0%); 64.3% of women achieved amenorrhea; 59.1% of women with anemia at the pivotal study baseline achieved a substantial improvement (>2 g/dL) in hemoglobin levels; and decreased symptom severity and distress because of uterine fibroid-associated symptoms and improvements in health-related quality of life through 52 weeks were demonstrated. The most frequently reported adverse events during the cumulative 52-week treatment period were hot flush (12.9%), headache (5.7%), and hypertension (5.7%). Bone mineral density was preserved through 52 weeks.

CONCLUSION:

Once-daily relugolix combination therapy improved uterine fibroid-associated heavy menstrual bleeding in most Black or African American women who participated in the LIBERTY Long-Term Extension study. The safety and efficacy profile of relugolix combination therapy in Black or African American women was consistent with previously published results from the overall study population through 52 weeks. Findings from this subanalysis will assist shared decision-making by helping providers and Black or African American women understand the efficacy and safety of relugolix combination therapy as a pharmacologic option for the management of uterine fibroid-associated symptoms.

2024-01-01·Fertility and sterility

Endocrine profile of the kisspeptin receptor agonist MVT-602 in healthy premenopausal women with and without ovarian stimulation: results from 2 randomized, placebo-controlled clinical tricals

Article

作者: Berman, Lance ; Ezzati, Max ; Migoya, Elizabeth ; Ufer, Mike ; Abbara, Ali ; Ferreira, Juan Camilo Arjona ; Lee, Tien-Yi ; Wu, Rui ; Voors-Pette, Christine ; Dhillo, Waljit S

BACKGROUND:

Kisspeptin is an essential regulator of hypothalamic gonadotropin-releasing hormone release and is required for physiological ovulation. Native kisspeptin-54 can induce oocyte maturation during in vitro fertilization treatment, including in women who are at high risk of ovarian hyperstimulation syndrome. MVT-602 is a potent kisspeptin receptor agonist with prospective utility to treat anovulatory disorders by triggering oocyte maturation and ovulation during medically assisted reproduction (MAR). Currently, the endocrine profile of MVT-602 during ovarian stimulation is unreported.

OBJECTIVE:

To determine the endocrine profile of MVT-602 in the follicular phase of healthy premenopausal women (phase-1 trial), and after minimal ovarian stimulation to more closely reflect the endocrine milieu encountered during MAR (phase-2a trial).

DESIGN:

Two randomized, placebo-controlled, parallel-group, dose-finding trials.

SETTING:

Clinical trials unit.

PATIENTS:

Healthy women aged 18-35 years, either without (phase-1; n = 24), or with ovarian stimulation (phase-2a; n = 75).

INTERVENTIONS:

Phase-1: single subcutaneous dose of MVT-602 (0.3, 1.0, or 3.0 μg) or placebo, (n = 6 per dose). Phase-2a: single subcutaneous dose of MVT-602 (0.1, 0.3, 1.0, or 3.0 μg; n = 16-17 per dose), triptorelin 0.2 mg (n = 5; active comparator), or placebo (n = 5).

MAIN OUTCOME MEASURES:

Phase-1: safety/tolerability; pharmacokinetics; and pharmacodynamics (luteinizing hormone [LH] and other reproductive hormones). Phase-2a: safety/tolerability; pharmacokinetics; pharmacodynamics (LH and other reproductive hormones); and time to ovulation assessed by transvaginal ultrasound.

RESULTS:

In both the trials, MVT-602 was safe and well tolerated across the entire dose range. It was rapidly absorbed and eliminated, with a mean elimination half-life of 1.3-2.2 hours. In the phase-2a trial, LH concentrations increased dose dependently; mean maximum change from baseline of 82.4 IU/L at 24.8 hours was observed after administration of 3 μg MVT-602 and remained >15 IU/L for 33 hours. Time to ovulation after drug administration was 3.3-3.9 days (MVT-602), 3.4 days (triptorelin), and 5.5 days (placebo). Ovulation occurred within 5 days of administration in 100% (3 μg), 88% (1 μg), 82% (0.3 μg), and 75% (0.1 μg), of women after MVT-602, 100% after triptorelin and 60% after placebo.

CONCLUSIONS:

MVT-602 induces LH concentrations of similar amplitude and duration as the physiological midcycle LH surge with potential utility for induction of oocyte maturation and ovulation during MAR.

CLINICAL TRIAL REGISTRATION NUMBER:

EUDRA-CT: 2017-003812-38, 2018-001379-20.

2023-12-01·European urology

Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study

Article

作者: Tombal, Bertrand ; Bossi, Alberto ; Shore, Neal ; Brown, Bruce ; Collins, Sean ; Hunsche, Elke ; Zhu, Emily ; Morgans, Alicia K

BACKGROUND:

Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, demonstrated testosterone suppression to castrate levels in men with advanced prostate cancer (PCa) in the HERO study. Since advanced PCa and its treatments can impact patients' daily life, it is imperative to understand the impact of systemic therapy on patient health-related quality of life (HRQOL).

OBJECTIVE:

To report the HRQOL for patients on relugolix compared with those on leuprolide in on-treatment and testosterone recovery periods of the HERO study.

DESIGN, SETTING, AND PARTICIPANTS:

A phase 3 randomized controlled study was conducted in 934 patients with advanced PCa.

INTERVENTION:

Patients underwent 2:1 randomization and received relugolix 120 mg orally once daily or leuprolide 3-mo injections for 48 wk. Testosterone recovery was evaluated in a patient subset.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

HRQOL evaluations were based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) and the Prostate Cancer Module (EORTC QLQ-PR25) during treatment and testosterone recovery phases. In a post hoc analysis, predictors of HRQOL deterioration were evaluated.

RESULTS AND LIMITATIONS:

No statistically significant differences between the two groups were found in changes from baseline to the end of treatment in either the EORTC QLQ-C30 or the EORTC QLQ-PR25 instrument. During the testosterone recovery phase, hormonal treatment-related symptoms scores were lower for relugolix than for leuprolide, suggesting a lower burden of hormone-related symptoms associated with a treatment that has more rapid testosterone recovery after treatment cessation. Limitations include low patient numbers in the testosterone recovery group.

CONCLUSIONS:

Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction.

PATIENT SUMMARY:

In men with advanced prostate cancer, relugolix had similar health-related quality of life to leuprolide.

项与 Myovant Sciences GmbH 相关的新闻（医药）

2023-08-11

·PRNewswire

Uterine Fibroid Treatment Drugs Industry Outlook 2023-2030: GnRH Antagonists Expected to Grow at the Fastest Rate

DUBLIN, Aug. 11, 2023 /PRNewswire/ -- The "Global Uterine Fibroid Treatment Drugs Market 2023-2030" report has been added to ResearchAndMarkets.com's offering. The global uterine fibroid treatment drugs market is projected to reach USD 3.91 billion by 2030, with a CAGR of 10.2% from 2022 to 2030. The market's growth is attributed to the increasing prevalence of uterine fibroids and the effectiveness of novel drugs in reducing heavy menstrual bleeding in affected women. Heavy menstrual bleeding is a common symptom of uterine fibroids, impacting around 1.4 million women per year, leading to reduced physical activity and affecting quality of life. The rising demand for drugs with advanced mechanisms, higher efficacy, and fewer side effects is driving the market. Funding for research activities is also contributing to market growth, as various organizations are endorsing acts to advance research and education on the condition. Multiple Gonadotropin-releasing Hormone (GnRH) antagonists have received approval for treating heavy bleeding associated with fibroids, further boosting the market. Key players are focusing on new launches, mergers, acquisitions, expansion, and partnerships to gain higher market shares. The report highlights that the GnRH antagonists segment is expected to grow at the fastest rate, and the recent approvals of drugs like Oriahnn, Myfembree, and Yselty are driving market growth. Submucosal fibroids held the majority share of the UF drugs market in 2022. Retail pharmacies dominated the market in 2022 due to easy medication availability. North America holds the largest share of the market in 2022 due to major players' presence, high prevalence of the health condition, and increasing awareness among patients regarding available medications. However, the market faces the challenge of generic drugs' availability, which may impact its growth to some extent. Overall, the uterine fibroid treatment drugs market is expected to witness significant growth driven by various factors, including rising prevalence, effective drugs, and increasing awareness about available treatments. Key Topics Covered Chapter 1 Methodology and Scope Chapter 2 Executive Summary Chapter 3 Uterine Fibroid Treatment Drugs Market Variables, Trends, & Scope Chapter 4 Uterine Fibroid Treatment Drugs Market - Segment Analysis, by Drug Class Chapter 5 Uterine Fibroid Treatment Drugs Market - Segment Analysis, By Type Chapter 6 Uterine Fibroid Treatment Drugs Market - Segment Analysis, By End-user Chapter 7 Uterine Fibroid Treatment Drugs Market: Regional Estimates and Trend Analysis Chapter 8 Competitive Landscape Myovant Sciences GmbH Pfizer Inc. Abbvie, Inc. Ferring B.V. Astrazeneca Bayer AG Amring Pharmaceuticals Inc. Watson Pharma, Inc. For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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