Yonsa (abiraterone acetate) / Churchill Pharma, Sun Pharma - LARVOL DELTA

OMAHA-004: A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (clinicaltrials.gov) - P3 | N=1314 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

THE IMPACT OF A GENERIC ALTERNATIVE ON MEDICARE PART D SPENDING FOR ABIRATERONE (SUO 2025) - " Publicly available Medicare Part D data was analyzed from 2013-2023 for all 3 abiraterone formulations available in the United States (Zytiga, Yonsa, and generic abiraterone), extracting number of unique beneficiaries, 30-day fills, and total Medicare Part D spending annually. The introduction of a generic version of abiraterone has led to billions of dollars in Medicare cost savings. Generic abiraterone has largely supplanted its branded counterpart, with 98% of abiraterone prescriptions in 2023 being generic. Generic utilization was associated with dramatic reductions in both total Medicare Part D spending and per-beneficiary cost despite an increase in the number of beneficiaries receiving abiraterone."

Medicare • Reimbursement • US reimbursement • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Prostate Cancer • Solid Tumor

OMAHA-004: A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (clinicaltrials.gov) - P3 | N=1314 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Dec 2030 ➔ May 2028

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose. (clinicaltrials.gov) - P1 | N=50 | Terminated | Sponsor: University of Chicago | Trial completion date: Nov 2025 ➔ Nov 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2025 ➔ Nov 2024; Closed by PI due to not meeting primary endpoint

Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

OMAHA1: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (clinicaltrials.gov) - P3 | N=1310 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

OMAHA-004: A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (clinicaltrials.gov) - P3 | N=1500 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

OMAHA1: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (clinicaltrials.gov) - P3 | N=1200 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment Prostate Cancer (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Mayo Clinic | N=57 ➔ 110

Enrollment change • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces (clinicaltrials.gov) - P=N/A | N=2313 | Completed | Sponsor: Pfizer | N=1000 ➔ 2313

Enrollment change • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=2731 | Completed | Sponsor: Pfizer | Trial completion date: Oct 2024 ➔ Feb 2025 | Trial primary completion date: Oct 2024 ➔ Feb 2025

Real-world evidence • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=3017 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

NCI-2018-01054: Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=7 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Apr 2025 ➔ Apr 2027 | Trial primary completion date: Apr 2025 ➔ Apr 2027

Biomarker • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PTEN

REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial (clinicaltrials.gov) - P3 | N=72 | Recruiting | Sponsor: Emory University | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

NCI-2018-01856: Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer (clinicaltrials.gov) - P2 | N=310 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Feb 2025 ➔ Feb 2027 | Trial primary completion date: Feb 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=2733 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Real-world evidence • Trial completion • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=2903 | Active, not recruiting | Sponsor: Pfizer | Completed ➔ Active, not recruiting | N=1800 ➔ 2903 | Trial completion date: Feb 2024 ➔ Jan 2025 | Trial primary completion date: Feb 2024 ➔ Jan 2025

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces (clinicaltrials.gov) - P=N/A | N=1000 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Apr 2024 | Trial primary completion date: Oct 2024 ➔ Apr 2024

Metastases • Trial completion • Trial completion date • Trial primary completion date • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Sumitomo Pharma Switzerland GmbH | Active, not recruiting ➔ Completed | N=72 ➔ 48 | Trial completion date: May 2025 ➔ May 2024 | Trial primary completion date: May 2025 ➔ May 2024

Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial (clinicaltrials.gov) - P3 | N=72 | Not yet recruiting | Sponsor: Emory University

Metastases • New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Sumitomo Pharma Switzerland GmbH | Trial completion date: May 2024 ➔ May 2025 | Trial primary completion date: May 2024 ➔ May 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Castration-Sensitive Prostate Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Oct 2024 ➔ Oct 2026 | Trial primary completion date: Oct 2024 ➔ Oct 2026

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=1800 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Feb 2024 | Trial primary completion date: Dec 2024 ➔ Feb 2024

Metastases • Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=2800 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Dec 2024

Metastases • Real-world • Real-world evidence • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Sumitomo Pharma Switzerland GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ May 2024 | Trial primary completion date: Jan 2023 ➔ May 2024

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

ACTIon: Abiraterone Acetate in Combination With Tildrakizumab (clinicaltrials.gov) - P1/2 | N=13 | Terminated | Sponsor: Institute of Cancer Research, United Kingdom | Trial completion date: Oct 2024 ➔ Nov 2023 | Active, not recruiting ➔ Terminated; Funder decided that response outcomes to date did not support continuation of the study.

Combination therapy • Metastases • Trial completion date • Trial termination • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • IL23A