CLINICAL TRIALS PROFILE FOR XTANDI

All Clinical Trials for Xtandi

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00268476 ↗	Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy	Recruiting	Medical Research Council	Phase 2/Phase 3	2005-07-08	The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-naïve prostate cancer. This trial aims to see if we can improve the way in which prostate cancer is currently managed, either by adding new treatments to the standard approach or by modifying the type of hormone therapy aiming to improve quality-of-life by reducing the side effects of treatment. Each new treatment approach is compared against a control arm receiving the current standard treatments. We aim to identify treatment strategies that enable men to live longer, or as long but with an improved quality-of-life, as well as offering value for money for the health service. Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate cancer and some results are now already known. More than 10,000 men will join the trial with answers becoming available throughout the trial. New patients joining the trial from Protocol version 17.0 onwards (activated in December 2018) may be eligible to join one of two treatment comparisons, metformin (treatment group K; the "metformin comparison") and transdermal oestradiol (treatment group L; the "transdermal oestradiol comparison"). A computer program will be used to allocate which treatment each participant receives, using a chance process. Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups currently open to recruitment (June 2017) 1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE will investigate whether adding metformin to the current standard-of-care for non-diabetic men can improve all-cause survival. 2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which has been shown to suppress testosterone as effectively as standard ADT and avoid some of the side-effects. It may also help to avoid the adverse metabolic effects and fatigue and therefore improve overall quality of life compared with standard forms of ADT. STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as current standard forms of ADT. 3. Control group (Arm A): Patients allocated to this group receive the current standard-of-care ADT +/- RT +/- docetaxel.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Astellas Pharma Inc	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Medivation LLC, a wholly owned subsidiary of Pfizer Inc.	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Medivation, Inc.	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Pfizer	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.

Clinical Trial Conditions for Xtandi

Condition Name

Condition Name for Xtandi
Intervention	Trials
Prostate Cancer	47
Stage IV Prostate Cancer	13
Castration-Resistant Prostate Carcinoma	13
Metastatic Castration-resistant Prostate Cancer	11

Condition MeSH

Condition MeSH for Xtandi
Intervention	Trials
Prostatic Neoplasms	135
Carcinoma	20
Adenocarcinoma	18
Prostatic Neoplasms, Castration-Resistant	11

Clinical Trial Locations for Xtandi

Trials by Country

Trials by Country for Xtandi
Location	Trials
United States	643
United Kingdom	122
Canada	89
France	82
Spain	75

Trials by US State

Trials by US State for Xtandi
Location	Trials
California	41
New York	35
Texas	32
Maryland	29
Illinois	28

Clinical Trial Progress for Xtandi

Clinical Trial Phase

Clinical Trial Phase for Xtandi
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	17
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Xtandi
Clinical Trial Phase	Trials
Completed	46
Recruiting	45
Active, not recruiting	31

Clinical Trial Sponsors for Xtandi

Sponsor Name

Sponsor Name for Xtandi
Sponsor	Trials
Medivation, Inc.	47
Astellas Pharma Inc	31
National Cancer Institute (NCI)	25

Sponsor Type

Sponsor Type for Xtandi
Sponsor	Trials
Industry	197
Other	144
NIH	25

Xtandi: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Xtandi, or enzalutamide, is a groundbreaking medication developed by Astellas Pharma Inc. and Pfizer Inc. for the treatment of various stages of prostate cancer. This article provides an in-depth look at the recent clinical trials, market performance, and future projections for Xtandi.

Mechanism of Action

Xtandi is a phenylimidazolidine derivative that acts as a triple-acting androgen receptor antagonist. It inhibits the activity of androgen receptors in prostate cancer cells, leading to a reduction in cell proliferation and a decrease in serum prostate-specific antigen (PSA) levels. This mechanism is crucial in managing prostate cancer, especially in cases where androgen receptor over-expression contributes to hormone resistance[5].

Clinical Trials Update

EMBARK Trial

The Phase 3 EMBARK trial has been pivotal in expanding the indications for Xtandi. This trial involved 1,068 men with non-metastatic castration-sensitive prostate cancer (nmCSPC) and high-risk biochemical recurrence (BCR). The study demonstrated that adding Xtandi to leuprolide significantly reduced the risk of metastasis or death by 58% compared to leuprolide monotherapy. The trial also showed improved metastasis-free survival (MFS) rates, with 92.9% and 87.3% MFS rates at 3 and 5 years, respectively, for the Xtandi group, compared to 83.5% and 71.4% for the placebo group[1][4].

ARCHES Trial

The Phase 3 ARCHES trial, conducted globally and in China, further solidified Xtandi's efficacy in treating metastatic hormone-sensitive prostate cancer (mHSPC). The trial showed that Xtandi in combination with androgen deprivation therapy (ADT) significantly delayed time to PSA progression and improved radiographic progression-free survival compared to placebo plus ADT[3].

FDA and Regulatory Approvals

Non-Metastatic Castration-Sensitive Prostate Cancer (nmCSPC)

In November 2023, the FDA approved Xtandi for the treatment of nmCSPC with high-risk BCR, making it the first and only androgen receptor signaling inhibitor approved for this indication. This approval was granted under FDA Priority Review, Fast Track, and Real-time Oncology Review designations[1][4].

European Approval

Following the FDA approval, the European Commission also approved Xtandi for the treatment of nmCSPC with high-risk BCR, based on the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)[4].

Chinese Approval

In July 2024, the China National Medical Products Administration (NMPA) approved Xtandi for the treatment of mHSPC, marking its third indication for advanced prostate cancer in China[3].

Market Analysis

Sales Performance

Xtandi has been a blockbuster drug since its first approval in 2012. As of 2023, global sales of Xtandi stood at $5,192.90 million, with a historical growth rate (CAGR) of 6.29% between 2020 and 2023. The drug has seen significant growth, particularly outside the U.S., with Astellas reporting a 24.4% sales increase for the nine months ended in December 2022[2][5].

Market Competition

Xtandi faces competition from other androgen receptor inhibitors such as Johnson & Johnson's Zytiga and Erleada, and Bayer's Nubeqa. However, Xtandi's robust clinical profile and expanded indications have helped it maintain a strong market position. Nubeqa, in particular, is seen as a fierce competitor, but Xtandi's legacy and broad range of approvals continue to support its market dominance[2].

Future Projections

Expanded Indications

With the recent approvals, Xtandi is poised to expand its patient base into earlier stages of prostate cancer. The drug is currently under review for additional indications, including pairing with other agents like Pfizer's PARP inhibitor Talzenna in metastatic castration-resistant prostate cancer (mCRPC)[2].

Global Reach

Astellas and Pfizer are actively discussing the data with regulatory authorities worldwide to bring Xtandi to more patients. The recent approval in China and ongoing discussions with European and other global regulatory bodies indicate a continued expansion of Xtandi's global footprint[3][4].

Financial Impact

The expanded approvals are expected to positively impact the financial forecasts of both Astellas and Pfizer. Astellas has already reflected the impact of the Chinese approval in its financial forecast for the fiscal year ending March 31, 2025[3][4].

Patient Impact

Clinical Significance

For patients with nmCSPC and high-risk BCR, the approval of Xtandi offers a significant improvement in treatment options. As noted by Courtney Bugler, president and CEO of ZERO Prostate Cancer, "This approval of Xtandi is a promising treatment option for the community, offering a ray of hope to patients and their caregivers during these challenging times"[1].

Quality of Life

The reduction in the risk of metastasis and death, as well as the delay in PSA progression, translates into improved quality of life for patients. Dr. Neal Shore, primary investigator of the EMBARK trial, emphasized that the FDA approval represents an important advancement in the treatment of BCR patients, especially those at high risk of developing metastases[1].

Key Takeaways

• Clinical Efficacy: Xtandi has demonstrated significant clinical efficacy in reducing the risk of metastasis and death in patients with nmCSPC and high-risk BCR.
• Regulatory Approvals: Recent FDA, European, and Chinese approvals have expanded Xtandi's indications into earlier stages of prostate cancer.
• Market Performance: Xtandi continues to show strong sales growth, with a global market presence and competition from other androgen receptor inhibitors.
• Future Projections: Expanded indications and global reach are expected to further solidify Xtandi's position in the prostate cancer treatment landscape.

FAQs

What is Xtandi used for?

Xtandi (enzalutamide) is used for the treatment of various stages of prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mHSPC), and non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence.

What are the key findings of the EMBARK trial?

The EMBARK trial showed that adding Xtandi to leuprolide reduced the risk of metastasis or death by 58% compared to leuprolide monotherapy, with improved metastasis-free survival rates.

How does Xtandi compare to other androgen receptor inhibitors?

Xtandi has a robust clinical profile and expanded indications, which have helped it maintain a strong market position despite competition from other androgen receptor inhibitors like Zytiga, Erleada, and Nubeqa.

What are the recent regulatory approvals for Xtandi?

Xtandi has recently been approved by the FDA, European Commission, and China's National Medical Products Administration for the treatment of nmCSPC with high-risk BCR and mHSPC.

What is the market performance of Xtandi?

Xtandi has shown strong sales growth, with global sales reaching $5,192.90 million in 2023 and a historical growth rate of 6.29% between 2020 and 2023.

What are the future projections for Xtandi?

Xtandi is expected to expand its patient base into earlier stages of prostate cancer, with ongoing discussions for additional indications and global regulatory approvals.

References

1. PharmExec: "Xtandi Approved by FDA for Nonmetastatic Castration-Sensitive Prostate Cancer"[1].
2. FiercePharma: "Astellas, Pfizer look to broaden Xtandi's patient base with new prostate cancer win after 8 years"[2].
3. Astellas: "China's National Medical Products Administration Approves XTANDI for Metastatic Hormone-Sensitive Prostate Cancer"[3].
4. Astellas: "Astellas' XTANDI TM (Enzalutamide) Granted European Commission Approval for Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence"[4].
5. GlobalData: "The Global Drug sales of Xtandi (2020 - 2026, USD Millions)"[5].

Last updated: 2025-01-01