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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

ERLEADA® (apalutamide)

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ERLEADA – PANTHER Study

Last Updated: 04/11/2025

SUMMARY

Efficacy results have been reported for the 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 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 (Figure: PANTHER Study Design)

PANTHER Study Design¹^-³

Abbreviations: ARPI, androgen receptor pathway inhibitor; BID, twice daily; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; PCWG3, Prostate Cancer Working Group 3; PO, orally; PSA, prostate-specific antigen; RECIST, Response Evaluation Criteria in Solid Tumors; rPFS, radiographic progression-free survival; OS, overall survival; QD, once daily.
^aAt this point, patients were switched to standard of care.

Results

Patient Demographics

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

Select Baseline Patient Characteristics¹

Characteristic	Black Patients (n=43)	White Patients (n=50)
Median age, years	67	72
Gleason score 8-10, %	56	56
Karnofsky performance status, 70-80%, %	26	18
Median PSA, ng/mL	15.20	17.56
Median time from diagnosis to enrollment, years	4.6	3.3
Visceral metastases, %	23.7	18.0
Prior docetaxel, %	33	44
Abbreviation: PSA, prostate-specific antigen.

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.

Efficacy Outcomes in Black and White Patients in the PANTHER Study¹^,²

Rate	Black Patients (n=43)	White Patients (n=50)
Long Term Efficacy Outcomes
24-month rPFS, % (95% CI)	61 (49-78)	38 (27-54)
rPFS events	22	40
36-month OS, % (95% CI)	68 (55-83)	50 (37-66)
OS events	20	35
Interim Efficacy Outcomes
12-month rPFS, % (95% CI)	79 (68-92)	51 (39-67)
24-month rPFS, % (95% CI)	63 (50-80)	38 (26-55)
rPFS events	18	36
12-month TTP, % (95% CI)	81 (69-94)	59 (43-80)
24-month TTP, % (95% CI)	59 (46-77)	39 (25-60)
12-month OS, % (95% CI)	95 (89-100)	84 (73-97)
24-month OS, % (95% CI)	83 (74-95)	65 (52-80)
OS events	15	30
n (%)
≥50% PSA decline	40 (93)	34 (68)
PSA <0.1	21 (49)	14 (28)
No PSA decline	1 (2.3)	7 (14)
Abbreviations: CI, confidence interval; OS, overall survival; PSA, prostate-specific antigen; rPFS, radiographic progression-free survival; TTP, time to PSA progression.

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 05 March 2025.

References

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1	George DJ, Halabi S, Fleming MT, et al. Overall survival from PANTHER: a multicenter trial of apalutamide, abiraterone acetate plus prednisone in Black and White patients with metastatic castration-resistant prostate cancer (mCRPC) [abstract]. J Clin Oncol. 2024;42(Suppl. 16):Abstract 5072.
2	George DJ, Halabi S, Fleming M, et al. A prospective trial of apalutamide and abiraterone acetate plus prednisone in Black and White men with metastatic castrate-resistant prostate cancer [abstract]. J Clin Oncol. 2023;41(Suppl. 16):Abstract 5015.
3	Janssen Research & Development, LLC. Apalutamide and abiraterone acetate in African American and Caucasian men with metastatic castrate resistant prostate cancer (PANTHER). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 February 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT03098836 NLM Identifier: NCT03098836.