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CLINICAL TRIALS PROFILE FOR ORGOVYX

All Clinical Trials for orgovyx

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03348670 ↗	Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms	Active, not recruiting	Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3	2023-08-18	The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes. The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
NCT03348670 ↗	Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms	Active, not recruiting	Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair	Phase 2/Phase 3	2023-08-18	The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes. The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
NCT04666129 ↗	Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer	Recruiting	Myovant Sciences GmbH	Phase 1	2021-02-18	This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).
NCT05050084 ↗	Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score	Not yet recruiting	National Cancer Institute (NCI)	Phase 3	2021-11-11	This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.
NCT05050084 ↗	Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score	Not yet recruiting	NRG Oncology	Phase 3	2021-11-11	This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.

Clinical Trial Conditions for orgovyx

Condition Name

Condition Name for orgovyx
Intervention	Trials
Prostate Cancer	4
Prostate Adenocarcinoma	2
Stage IIC Prostate Cancer AJCC v8	2
Stage III Prostate Cancer AJCC v8	2

Condition MeSH

Condition MeSH for orgovyx
Intervention	Trials
Prostatic Neoplasms	8
Carcinoma	1
Adenocarcinoma	1
Hypersensitivity	1

Clinical Trial Locations for orgovyx

Trials by Country

Trials by Country for orgovyx
Location	Trials
United States	11

Trials by US State

Trials by US State for orgovyx
Location	Trials
Maryland	2
Kansas	1
Connecticut	1
Massachusetts	1
Georgia	1

Clinical Trial Progress for orgovyx

Clinical Trial Phase

Clinical Trial Phase for orgovyx
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for orgovyx
Clinical Trial Phase	Trials
Not yet recruiting	6
Recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for orgovyx

Sponsor Name

Sponsor Name for orgovyx
Sponsor	Trials
National Cancer Institute (NCI)	4
Myovant Sciences GmbH	3
NRG Oncology	2

Sponsor Type

Sponsor Type for orgovyx
Sponsor	Trials
Other	7
Industry	7
NIH	4

Orgovyx Market Analysis and Financial Projection

Orgovyx (Relugolix): A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Orgovyx, also known as relugolix, is a groundbreaking oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. Here, we delve into the clinical trials that led to its approval, its market performance, and future projections.

Clinical Trials Overview

The HERO Study

The pivotal Phase III clinical trial, known as the HERO study, was instrumental in the FDA approval of Orgovyx. This randomized, open-label study involved 930 patients with androgen-sensitive advanced prostate cancer, who were randomized 2:1 to receive either Orgovyx or leuprolide acetate injections every three months for 48 weeks[2][3][4].

Primary Efficacy Endpoint

The primary efficacy endpoint was the medical castration rate, defined as achieving and maintaining serum testosterone suppression to castrate levels (<50 ng/dL) from Day 29 through 48 weeks of treatment. The results were impressive, with 96.7% of patients in the Orgovyx group achieving and maintaining sustained testosterone suppression, significantly exceeding the 90% threshold[2][4].

Additional Efficacy Metrics

In addition to the primary endpoint, the study also measured the sustained profound castration rate (<20 ng/dL), which was higher in the Orgovyx group (81.6%) compared to the leuprolide group (68.6%)[2].

Safety Profile

The safety profile of Orgovyx was evaluated in the same trial, showing that while it had a favorable benefit-harm-uncertainty profile, it was associated with some side effects such as increased glucose and triglycerides, and decreased hemoglobin levels[4].

OPTYX Study: Real-World Evidence

To further understand the real-world effectiveness and safety of Orgovyx, the OPTYX study is currently underway. This multi-center, prospective, observational study aims to enroll 1000 patients with advanced prostate cancer from various clinical settings across the USA. The study will collect data on treatment patterns, adherence, safety, and health-related quality-of-life (HRQOL) outcomes, providing valuable real-world evidence for practitioners and researchers[1].

Market Analysis

FDA Approval and Launch

Orgovyx received FDA approval on December 18, 2020, following a priority review. It was launched on January 5, 2021, marking a significant shift in the treatment paradigm for advanced prostate cancer by offering an oral alternative to traditional injectable therapies[3][5].

Market Performance

Since its launch, Orgovyx has shown promising market performance. In its first launch quarter, Myovant Sciences reported $3.6 million in product revenue, with over 2,000 prescriptions. This momentum continued, with net product revenues of $10.5 million in the first quarter of 2021, exceeding analyst expectations[5].

Partnership and Marketing

Myovant Sciences has partnered with Pfizer to co-market Orgovyx, a deal worth over $650 million. This partnership has been instrumental in expanding the reach of the drug, targeting healthcare providers and building out payer coverage. The positive feedback from clinicians and the recognition of payers have contributed to the early success of Orgovyx[5].

Market Projections

Growing Demand

The demand for Orgovyx is expected to grow as more patients and healthcare providers become aware of its benefits. The convenience of an oral medication, combined with its efficacy and safety profile, positions Orgovyx as a potential new standard of care in androgen deprivation therapy[5].

Expanding Indications

While currently approved for advanced prostate cancer, Myovant Sciences is exploring additional indications for relugolix, including heavy menstrual bleeding associated with uterine fibroids and endometriosis. These potential expansions could further boost the market presence of Orgovyx[3].

Competitive Landscape

Orgovyx enters a market dominated by injectable GnRH agonists like leuprolide acetate. However, its unique oral formulation and favorable clinical profile are expected to capture a significant share of the market, especially among patients who prefer or require an oral treatment option[5].

Key Takeaways

• Clinical Efficacy: Orgovyx has demonstrated high efficacy in achieving and maintaining medical castration, with 96.7% of patients achieving sustained testosterone suppression.
• Real-World Evidence: The ongoing OPTYX study will provide valuable insights into the real-world effectiveness and safety of Orgovyx.
• Market Performance: Orgovyx has shown strong market performance since its launch, with revenues exceeding expectations.
• Partnerships and Marketing: The partnership with Pfizer has been crucial in expanding the reach and coverage of Orgovyx.
• Future Projections: The demand for Orgovyx is expected to grow, driven by its convenience, efficacy, and potential expansion into additional indications.

FAQs

What is Orgovyx and how does it work?

Orgovyx (relugolix) is an oral GnRH receptor antagonist that works by blocking the pituitary gland from producing luteinizing hormone and follicle-stimulating hormone, thereby reducing testosterone production in the testes[5].

What were the key findings of the HERO study?

The HERO study showed that 96.7% of patients treated with Orgovyx achieved and maintained sustained testosterone suppression to castrate levels, and it also demonstrated a higher sustained profound castration rate compared to leuprolide acetate[2][4].

What is the OPTYX study, and what does it aim to achieve?

The OPTYX study is a multi-center, prospective, observational study designed to generate real-world evidence on the safety and effectiveness of Orgovyx in routine care settings, including treatment patterns, adherence, and health-related quality-of-life outcomes[1].

How has Orgovyx performed in the market since its launch?

Since its launch, Orgovyx has shown strong market performance, with revenues exceeding analyst expectations and over 2,000 prescriptions in the first quarter[5].

What are the potential future indications for Orgovyx?

In addition to advanced prostate cancer, Orgovyx is being explored for other indications such as heavy menstrual bleeding associated with uterine fibroids and endometriosis[3].

Sources

1. Oncology Central: Evaluating relugolix for the treatment of prostate cancer in real-world settings of care: the OPTYX study protocol.
2. Health Canada: Summary Basis of Decision (SBD) for Orgovyx.
3. Clinical Trials Arena: ORGOVYX (relugolix) for the Treatment of Advanced Prostate Cancer.
4. FDA: Drug Trial Snapshot: ORGOVYX.
5. Pharmaceutical Executive: Formidable Option: Orgovyx.