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EMBARK: Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos
Publications
Articles and Abstracts

Serum tumor markers can be a blessing and a curse. After definitive local therapy for prostate cancer, prostate-specific antigen (PSA) is quite sensitive and specific, and can detect micrometastatic disease well before any radiographic or symptomatic evidence of disease. When biochemical recurrence (BCR) occurs, early detection can guide curative-intent salvage therapies such as salvage radiation.

Purpose/Objective(s): The primary analysis of EMBARK demonstrated that after a median follow-up of 60.7 months metastasis-free survival (MFS) for enzalutamide (enza) + leuprolide acetate (LA; hazard ratio [HR] 0.42; 95% confidence interval [CI], 0.30–0.61; p<0.0001) and enza monotherapy (mono; HR 0.63; 95% CI, 0.46–0.87; p=0.0049) was clinically meaningful and statistically superior to placebo + LA. Here, we present a subgroup analysis of MFS by prior radiotherapy (RT).
Biochemical recurrence (BCR) has been defined as rising prostate-specific antigen (PSA) levels after definitive therapy (e.g., radical prostatectomy or radiotherapy) without evidence of metastasis by conventional imaging (i.e., bone scan and computed tomography).1

Enzalutamide and Quality of Life in Prostate CancerFreedland et al. present the health-related quality of life outcomes for patients with biochemically recurrent prostate cancer who were randomly assigned to enzalutamide plus leuprolide, enzalutamide monotherapy, or leuprolide alone (EMBARK trial).

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy* in nonmetastatic castration-sensitive prostate cancer

Reno, Nevada (UroToday.com) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide),
If approved, XTANDI would become the first and only novel hormone therapy approved in this earlier type of prostate cancer


Reno, Nevada (UroToday.com) --Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the companies' supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide)

Volume 209, Supplement 4, Page e1190: The abstract text is as given below. This erratum also includes the additional disclosure, conflict of interest, and acknowledgments that were not included in the original publication.

  • Data from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting
  • Results show the potential for XTANDI to add to the standard of care in prostate cancer, if approved
Reno, Nevada (UroToday.com) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58%
Pfizer and Astellas announce positive topline results from Phase 3 EMBARK trial

Reno, Nevada (UroToday.com) -- Pfizer Inc. and Astellas Pharma Inc. announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).

Limited data from controlled clinical trials are available for men who experience biochemical recurrence after definitive therapy for prostate cancer. In the absence of overt metastases, patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) often receive androgen deprivation therapy (ADT).

Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Stephen J. Freedland, MD
The 2024 ASCO annual meeting featured a session on prostate cancer, and a presentation by Dr. Stephen Freedland discussing a post hoc analysis of EMBARK assessing sexual activity patient-reported outcomes in patients who were sexually active or interested in sex at baseline.
Presented by Stephen J. Freedland, MD
The 2024 ASCO annual meeting featured a session on prostate cancer, and a presentation by Dr. Stephen Freedland discussing a post hoc analysis of EMBARK assessing the impact of treatment suspension on health-related quality of life.
Presented by Stephen Freedland, MD
The 2024 American Urological Association (AUA) Annual Meeting held in San Antonio, TX between May 3rd and 6th, 2024 was host to an advanced prostate cancer podium session. Dr. Stephen Freedland presented the results of a post hoc analysis of EMBARK evaluating PSA dynamics.
Presented by Bertrand Tombal, MD, PhD
The 2024 APCCC meeting featured a session on the treatment for biochemical recurrence/PSA persistence, and a presentation by Dr. Bertrand Tombal discussing patients with high-risk first biochemical recurrence after radical prostatectomy who are candidates for systemic therapy alone without local salvage radiotherapy.
Presented by Stephen Freedland, MD
(UroToday.com) The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA was host to a prostate cancer poster session. Dr. Stephen Freedland presented an EMBARK post hoc analysis of sexual activity-related patient reported outcome measures.
Presented by Stephen Freedland, MD
(UroToday.com) The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between January 25th and 27th was host to a prostate cancer poster session. Dr. Stephen Freedland presented the results of an EMBARK post-hoc analysis evaluating enzalutamide combination treatment suspension in men with high-risk biochemically recurrent prostate cancer.
Presented by Boris A. Hadaschik, MD
(UroToday.com) At the 2023 ESMO annual meeting, Dr. Boris Hadaschik presented on prostate cancer, discussing three abstracts from the EMBARK study by Dr. Stephen Freedland, the STAMPEDE trials by Dr. Charles Parker, and fracture-related hospitalizations by Dr. Craig Jones.
Presented by Stephen J. Freedland, MD
(UroToday.com) The 2023 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Stephen Freedland discussing health-related quality of life in nonmetastatic hormone-sensitive prostate cancer patients with high-risk biochemical recurrence from the EMBARK study. Enzalutamide + leuprolide acetate and enzalutamide alone delayed metastasis-free survival (MFS) vs placebo + leuprolide acetate in high-risk BCR nonmetastatic hormone-sensitive prostate cancer in the phase 3 EMBARK trial:1
Presented by Stephen Freedland, MD
(UroToday.com) The 2023 European Society of Medical Oncology (ESMO) Annual Congress held in Madrid, Spain between October 20th and 24th, 2023 was host to a prostate cancer abstracts poster session. Dr. Stephen Freedland presented results of the secondary analysis of EMBARK, specifically those pertaining to enzalutamide in combination with leuprolide acetate for the treatment of prostate cancer patients with high-risk biochemical recurrence.
Presented by Ugo F. De Giorgi, MD, PhD
(UroToday.com) The 2023 European Society of Medical Oncology (ESMO) Annual Congress held in Madrid, Spain between October 20th and 24th, 2023 was host to a prostate cancer abstracts poster session. Dr. Ugo De Giorgi presented results of the secondary analysis of EMBARK, specifically those pertaining to enzalutamide monotherapy for the treatment of prostate cancer patients with high-risk biochemical recurrence.
Presented by Dr. Anne Rajkumar, MD
Dr. Rajkumar began by presenting a case of a 56-year-old male with Gleason score 4+5=9 disease, PSA 5.1 ng/ml, and with evidence of extraprostatic extension on imaging. His PSMA-PET was negative for regional and distant disease. He declined surgery in favor of radiation therapy. Given his NCCN high-risk classification, what are considerations for his hormone therapy?
Presented by Wesley R. Armstrong
(UroToday.com) The 2023 ASCO annual meeting included a prostate cancer session featuring a presentation by Wesley Armstrong discussing PSMA PET findings in an “EMBARK-like” cohort of patients with high-risk non-metastatic hormone-sensitive prostate cancer. Non-metastatic hormone-sensitive prostate cancer is defined by rising PSA levels while naïve or responsive to ADT and without evidence of metastasis on conventional imaging. 
Presented by Neal Shore, MD, FACS
(UroToday.com) Dr. Neal Shore continued the morning plenary session with an excellent presentation on the late breaking abstract regarding the EMBARK clinical trial for high risk biochemically recurrent prostate cancer. The trial started recruitment in January 2015 and accrued the final patients in August 2018.
Presented by Neal Shore, MD, FACS
(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL, was host to a plenary session with Dr. Neal Shore presenting the long-awaited results of EMBARK, a phase 3 randomized study of enzalutamide or placebo plus leuprolide acetate and enzalutamide monotherapy in high-risk biochemically recurrent prostate cancer.