SUMMARY  

• Efficacy results have been reported for the ongoing, phase 2, prospective PANTHER study (NCT03098836) evaluating the use of ERLEADA and abiraterone acetate plus prednisone (AAP) in Black (n=43) and White (n=50) patients with metastatic castration-resistant prostate cancer (mCRPC) (Table: Efficacy Outcomes in Black and White Patients in the PANTHER Study).^1,2

CLINICAL DATA

George et al (2024)¹ and (2023)² reported results of the ongoing PANTHER study evaluating the efficacy and safety of ERLEADA and AAP in patients with mCRPC stratified by race (Black, n=43; White, n=50).

Study Design/Methods

• Phase 2, prospective, open-label, multicenter, parallel cohort study
• All patients were treated with ERLEADA 240 mg orally (PO) once daily (QD), abiraterone acetate 1000 mg PO QD, and prednisone 5 mg PO twice daily (BID) until unacceptable toxicity, disease progression, or 2 years,³ at which point patients were switched to standard of care.
• Select inclusion criteria: mCRPC, prior docetaxel allowed in the metastatic castration-sensitive prostate cancer (mCSPC) setting, adequate lab function, evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST)/Prostate Cancer Working Group 3 (PCWG3), self-reported race as either Black/African American or White
• Select exclusion criteria: prior treatment with an androgen receptor pathway inhibitor (ARPI), prior treatment with ketoconazole for prostate cancer >7 days
• Primary endpoint: radiographic progression-free survival (rPFS)
• Secondary endpoints: time to prostate-specific antigen (PSA) progression, overall survival (OS), PSA response
• Exploratory endpoints: safety, correlative biomarkers of outcome by race and ancestry

Results

Patient Demographics

• Key baseline characteristics for each cohort are summarized in Table: Select Baseline Patient Characteristics.

Efficacy

• Efficacy outcomes for both cohorts are summarized in Table: Efficacy Outcomes in Black and White Patients in the PANTHER Study. In the long term efficacy analysis, the median follow-up was 56 months and 62 months for the Black and White cohort, respectively.

Safety

• Safety results were not reported.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 30 May 2024.