CLINICAL TRIALS PROFILE FOR ERLEADA

All Clinical Trials for Erleada

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02366494 ↗	Micro RNAs to Predict Response to Androgen Deprivation Therapy	Active, not recruiting	Medical College of Wisconsin		2015-04-29	Identify exosomal micro RNA that predict responses to ADT
NCT03009981 ↗	A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer	Recruiting	Janssen Research & Development, LLC	Phase 3	2017-03-06	This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
NCT03009981 ↗	A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer	Recruiting	Alliance Foundation Trials, LLC.	Phase 3	2017-03-06	This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
NCT03279250 ↗	Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer	Completed	Janssen Scientific Affairs, LLC	Phase 2	2017-10-13	This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.
NCT03279250 ↗	Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 2	2017-10-13	This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.
NCT03360721 ↗	Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer	Suspended	Janssen Scientific Affairs, LLC	Phase 2	2018-03-06	This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abiraterone acetate and apalutamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as prednisone, is used to decrease the body's immune response and may improve bone marrow function. Giving apalutamide, abiraterone acetate, and prednisone may work better in treating participants with castration resistant prostate cancer.
NCT03360721 ↗	Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer	Suspended	National Cancer Institute (NCI)	Phase 2	2018-03-06	This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abiraterone acetate and apalutamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as prednisone, is used to decrease the body's immune response and may improve bone marrow function. Giving apalutamide, abiraterone acetate, and prednisone may work better in treating participants with castration resistant prostate cancer.

Clinical Trial Conditions for Erleada

Condition Name

Condition Name for Erleada
Intervention	Trials
Prostate Adenocarcinoma	9
Stage IVA Prostate Cancer AJCC v8	7
Prostate Cancer	7
Stage IIIA Prostate Cancer AJCC v8	5

Condition MeSH

Condition MeSH for Erleada
Intervention	Trials
Prostatic Neoplasms	20
Adenocarcinoma	6
Carcinoma	5
Hypersensitivity	2

Clinical Trial Locations for Erleada

Trials by Country

Trials by Country for Erleada
Location	Trials
United States	157
Canada	6
China	2
Brazil	1
Czechia	1

Trials by US State

Trials by US State for Erleada
Location	Trials
Texas	11
California	10
Ohio	7
Pennsylvania	6
New York	6

Clinical Trial Progress for Erleada

Clinical Trial Phase

Clinical Trial Phase for Erleada
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	12
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Erleada
Clinical Trial Phase	Trials
Recruiting	12
Not yet recruiting	3
Suspended	3

Clinical Trial Sponsors for Erleada

Sponsor Name

Sponsor Name for Erleada
Sponsor	Trials
National Cancer Institute (NCI)	10
Janssen Scientific Affairs, LLC	7
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for Erleada
Sponsor	Trials
Other	19
Industry	12
NIH	10

ERLEADA (Apalutamide): Clinical Trials, Market Analysis, and Projections

Introduction

ERLEADA (apalutamide) is a significant player in the treatment of prostate cancer, particularly in the metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC) settings. Here, we delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

TITAN Study

The TITAN study was a pivotal Phase 3 trial that evaluated the efficacy of ERLEADA in combination with androgen deprivation therapy (ADT) in patients with mCSPC. The study demonstrated a statistically significant superior overall survival benefit of ERLEADA plus ADT compared to ADT alone. At the primary analysis after a median 22.7 months of follow-up, the hazard ratio (HR) was 0.67 (95% CI, 0.51-0.89; P=0.005), and at the final analysis after a median 44 months of follow-up, the HR was 0.65 (95% CI, 0.53-0.79; P<0.0001)[2][4].

Real-World Head-to-Head Study

A recent landmark real-world study presented at the 6th European Congress of Oncology Pharmacy compared ERLEADA directly with enzalutamide in nearly 4,000 patients with mCSPC. This study, adhering to FDA real-world evidence guidelines, showed that ERLEADA reduced the risk of death by 23% at 24 months compared to enzalutamide (HR, 0.77; 95% CI, 0.62-0.96; P<0.019)[1][4][5].

Market Analysis

Current Market Position

ERLEADA has been approved by the U.S. FDA for both nmCRPC (February 2018) and mCSPC (September 2019). As of the latest reports, more than 150,000 patients worldwide have been treated with ERLEADA[3].

Competition

The prostate cancer market is highly competitive, with other notable drugs such as enzalutamide (Xtandi) from Astellas and Pfizer, and abiraterone acetate (Zytiga) from Johnson & Johnson. Xtandi has been approved for both metastatic and non-metastatic prostate cancer and has shown significant market share, particularly after its label expansion[2].

Market Share and Revenue

Despite the competition, ERLEADA is expected to be a key growth driver for Johnson & Johnson. While Zytiga's sales have declined due to generic competition, ERLEADA's supportive data from clinical trials is anticipated to help offset these losses. Johnson & Johnson's financial strength, with a market capitalization of $389.95 billion and a 5.13% revenue growth over the last twelve months, positions the company well to invest in further research and development[5].

Projections

Future Growth

Given the statistically significant and clinically meaningful survival benefits demonstrated by ERLEADA in both the TITAN study and the real-world head-to-head study, the drug is poised for continued growth. Johnson & Johnson plans to continue evaluating overall survival and long-term safety, which could lead to additional regulatory filings and expanded indications[2][4].

Ongoing Studies

Several ongoing Phase 3 studies, including ATLAS and PROTEUS, are evaluating ERLEADA in different settings such as localized prostate cancer with radiation therapy and after radical prostatectomy. These studies could further broaden ERLEADA's therapeutic scope and market potential[3].

Market Strategies

Johnson & Johnson is focusing on optimizing payer strategies and outcomes-based contracting to convey the benefits of ERLEADA effectively. This approach is expected to enhance market penetration and patient access to the drug[2].

Safety and Side Effects

Cerebrovascular Events

In the SPARTAN study, cerebrovascular events occurred in 2.5% of patients treated with ERLEADA compared to 1% of patients treated with placebo. This highlights the need for careful patient monitoring and management of potential side effects[3].

Key Takeaways

• Clinical Efficacy: ERLEADA has demonstrated significant overall survival benefits in both clinical trials and real-world studies, particularly in the mCSPC setting.
• Market Position: Despite competition from other ARPIs, ERLEADA is expected to be a key growth driver for Johnson & Johnson.
• Future Growth: Ongoing studies and potential expanded indications could further enhance ERLEADA's market potential.
• Safety: Patients should be monitored for potential side effects such as cerebrovascular events.

FAQs

What is ERLEADA used for?

ERLEADA (apalutamide) is used for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC)[3].

How does ERLEADA compare to enzalutamide?

A recent real-world study showed that ERLEADA reduced the risk of death by 23% at 24 months compared to enzalutamide in patients with mCSPC[1][4][5].

What are the ongoing studies for ERLEADA?

Ongoing Phase 3 studies include ATLAS and PROTEUS, evaluating ERLEADA in localized prostate cancer settings[3].

What are the potential side effects of ERLEADA?

ERLEADA has been associated with cerebrovascular events, occurring in 2.5% of patients treated with the drug compared to 1% of those treated with placebo[3].

How is Johnson & Johnson positioning ERLEADA in the market?

Johnson & Johnson is focusing on optimizing payer strategies and outcomes-based contracting to effectively convey the benefits of ERLEADA[2].

Sources

1. PR Newswire: ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer.
2. BioPharma Dive: J&J's Erleada has big shoes to fill, and a tough competitor to boot.
3. PR Newswire: Johnson & Johnson Highlights Ambition to Transform the Treatment of Prostate Cancer and Bladder Cancer Through Data Presentations at ASCO GU.
4. Johnson & Johnson: ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer.
5. Investing.com: ERLEADA shows survival benefit in prostate cancer study.