Apalutamide

(Erleada®)

Erleada®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 60 mg, 240 mg)
Drug ClassAndrogen receptor inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with metastatic castration-sensitive prostate cancer
  • Indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

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Summary
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  • This summary is based on the review of 48 systematic review(s)/meta-analysis(es). [1-48]
  • Apalutamide significantly improved Overall Survival (OS) in high-volume metastatic hormone-sensitive prostate cancer (mHSPC) patients, with a hazard ratio (HR) of 0.70 (95% confidence interval (CI): 0.56-0.88), compared to androgen deprivation therapy (ADT) alone.
  • No significant difference in Event-Free Survival (EFS) or OS was observed between intermittent PEG-asparaginase (eight doses) and continuous PEG-asparaginase (15 doses) in non-high risk acute lymphoblastic leukemia (ALL) patients. Similarly, there was no difference between low-risk standard treatment with additional PEG-asparaginase (six doses) and standard treatment (two doses), with risk ratios (RR) close to 1.
  • Rifamycin-SV significantly reduced Time to Last Unformed Stool (TLUS) compared to placebo in all severity groups, with a HR of 1.
  • Apalutamide was associated with a notable improvement in Progression-Free Survival (PFS) in high-volume mHSPC, with a HR of 0.73 (95% CI: 0.65-0.81), compared to androgen-deprivation therapy (ADT) alone.
  • In non-metastatic castration-resistant prostate cancer (nmCRPC), apalutamide significantly increased Metastasis-Free Survival (MFS), with a hazard ratio (HR) of 0.28 (95% CI: 0.23-0.35), compared to placebo.
  • Apalutamide had a higher incidence of Grade 3 or higher adverse events (AEs), with an odds ratio (OR) of 1.9 (95% CI: 1.4-2.7), compared to placebo, and a higher risk of serious adverse events (OR = 1.9, 95% CI: 1.3-2.8). There was also an increased risk of cognitive toxic effects (RR, 2.10; 95% CI: 1.30-3.38) and a higher risk of falls (RR = 1.87, 95% CI: 1.27-2.75).
  • Apalutamide maintained health-related quality of life (HRQoL) similarly to ADT alone or in combination with docetaxel, with no significant prolongation of time to first deterioration of pain.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Erleada (apalutamide) Prescribing Information.2024Janssen Biotech, Inc., Titusville, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Cardiovascular events among men with prostate cancer treated with androgen receptor signaling inhibitors: a systematic review, meta-analysis, and network meta-analysis2024Prostate Cancer and Prostatic Diseases
Network meta-analysis of combination strategies in metastatic hormone-sensitive prostate cancer2024Asian Journal of Andrology
Does Research from Clinical Trials in Metastatic Hormone-sensitive Prostate Cancer Treatment Translate into Access to Treatments for Patients in the "Real World"? A Systematic Review2024European Urology Oncology
Health-related quality of life in patients with metastatic hormone-sensitive prostate cancer treated with androgen receptor signaling inhibitors: the role of combination treatment therapy2024Prostate Cancer and Prostatic Diseases
Systemic therapies for high-volume metastatic hormone-sensitive prostate cancer: a network meta-analysis2023Acta Oncologica
The optimal upfront therapy in metastatic hormone-sensitive prostate cancer: A network meta-analysis2023Journal of Cancer Research and Therapeutics
Association of Second-generation Antiandrogens With Cognitive and Functional Toxic Effects in Randomized Clinical Trials: A Systematic Review and Meta-analysis2023JAMA Oncology
Combination therapy for high-volume versus low-volume metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis2023Frontiers in Pharmacology
Comparative efficacy of second-generation androgen receptor inhibitors for treating prostate cancer: A systematic review and network meta-analysis2023Frontiers in Endocrinology
Comparison of doublet and triplet therapies for metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis2023Frontiers in Oncology
First-line Systemic Treatment Options for Metastatic Castration-Sensitive Prostate Cancer: A Living Systematic Review and Network Meta-analysis2023JAMA Oncology
The efficacy and adverse events of conventional and second-generation androgen receptor inhibitors for castration-resistant prostate cancer: A network meta-analysis2023Frontiers in Endocrinology
Risk of cognitive impairment in men with advanced prostate cancer treated with NHAs: A systematic review and network meta-analysis2023Clinical and Translational Science
Efficacy and safety of therapies for advanced prostate cancer in Asia: Evidence from a systematic literature review2022Therapeutic Advances in Medical Oncology
Survival modelling and cost-effectiveness analysis of treatments for newly diagnosed metastatic hormone-sensitive prostate cancer2022PLoS One
Systemic triplet therapy for metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis2022Frontiers in Pharmacology
Androgen Receptor Signaling Inhibitors in Addition to Docetaxel with Androgen Deprivation Therapy for Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Meta-analysis2022European Urology
Combination therapy in metastatic castration sensitive prostate cancer: A Systematic review and network meta-analysis2022Indian Journal of Urology
Chemotherapy and advanced androgen blockage, alone or combined, for metastatic hormone-sensitive prostate cancer a systematic review and meta-analysis2022Cancer Treatment Reviews
Matching-adjusted indirect treatment comparison of the efficacy of enzalutamide versus apalutamide for the treatment of nonmetastatic castration-resistant prostate cancer2022ESMO Open
Treatments for Metastatic Hormone-sensitive Prostate Cancer: Systematic Review, Network Meta-analysis, and Benefit-harm assessment2022European Urology Oncology
Impact of New Systemic Therapies in Overall Survival in Non-Metastatic Castration Resistant Prostate Cancer: Systematic Review and Meta-Analysis2022Clinical Genitourinary Cancer
A meta-analysis on overall survival and safety outcomes in patients with nonmetastatic castration-resistant prostate cancer treated with novel hormonal agents2022Anticancer Drugs
Androgen receptor axis-targeted agents for non-metastatic castration-resistant prostate cancer impact on overall survival and safety profile2022Minerva Urology and Nephrology
Systemic therapies for metastatic hormone-sensitive prostate cancer: network meta-analysis2022BJU International
Overall survival and adverse events after treatment with darolutamide vs. apalutamide vs. enzalutamide for high-risk non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis2022Prostate Cancer and Prostatic Diseases
Overall Survival After Systemic Treatment in High-volume Versus Low-volume Metastatic Hormone-sensitive Prostate Cancer: Systematic Review and Network Meta-analysis2022European Urology Focus
Comparison of Treatments for Nonmetastatic Castration-Resistant Prostate Cancer: Matching-Adjusted Indirect Comparison and Network Meta-Analysis2022Journal of the National Cancer Institute
Association of Novel Androgen Receptor Axis-Targeted Therapies With Diarrhea in Patients With Prostate Cancer: A Bayesian Network Analysis2021Frontiers in Medicine
Novel Androgen Receptor Inhibitors in Non-Metastatic, Castration-Resistant Prostate Cancer: A Systematic Review and Network Meta-Analysis2021Frontiers in Oncology
Seizures and Neuropsychiatric Toxicity in Patients with Non-Metastatic CRPC Treated with New Antiandrogens: Systematic Review and Meta-Analysis2021Oncology Research and Treatment
Apalutamide, darolutamide and enzalutamide in nonmetastatic castration-resistant prostate cancer: a meta-analysis2021Future Oncology
Comparison of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis2021JAMA Oncology
First-line systemic therapy for metastatic castration-sensitive prostate cancer: An updated systematic review with novel findings2021Critical Reviews in Oncology/Hematology
Cognition and depression effects of androgen receptor axis-targeted drugs in men with prostate cancer: A systematic review2021Journal of Geriatric Oncology
Health-related Quality of Life in Patients with Advanced Prostate Cancer: A Systematic Review2021European Urology Focus
Evaluation of Fall and Fracture Risk Among Men With Prostate Cancer Treated With Androgen Receptor Inhibitors: A Systematic Review and Meta-analysis2020JAMA Network Open
Comparative Efficacy of Combined Radiotherapy, Systemic Therapy, and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer: A Network Meta-Analysis and Systematic Review2020Frontiers in Oncology
Comparison of Current Systemic Combination Therapies for Metastatic Hormone-Sensitive Prostate Cancer and Selection of Candidates for Optimal Treatment: A Systematic Review and Bayesian Network Meta-Analysis2020Frontiers in Oncology
Apalutamide, enzalutamide, and darolutamide for non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis2020International Journal of Clinical Oncology
Evaluation of Cognitive Function in Trials Testing New-Generation Hormonal Therapy in Patients with Prostate Cancer: A Systematic Review2020Cancers
Comparative efficacy of apalutamide darolutamide and enzalutamide for treatment of non-metastatic castrate-resistant prostate cancer: A systematic review and network meta-analysis2020Urologic Oncology
Predictors of efficacy of androgen-receptor-axis-targeted therapies in patients with metastatic castration-sensitive prostate cancer: A systematic review and meta-analysis2020CriticalReviews in Oncology/Hematology
A Systematic Review and Network Meta-analysis of Novel Androgen Receptor Inhibitors in Non-metastatic Castration-resistant Prostate Cancer2020Clinical Genitourinary Cancer
Systemic Management for Nonmetastatic Castration-resistant Prostate Cancer: A Systematic Review and Network Meta-Analysis2020American Journal of Clinical Oncology
Matching-Adjusted Indirect Comparison of the Efficacy of Apalutamide and Enzalutamide with ADT in the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer2020Advances in Therapy
Indirect Comparisons of Efficacy between Combination Approaches in Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis2020European Urology
Role of novel hormonal therapies in the management of non-metastatic castration-resistant prostate cancer: a literature-based meta-analysis of randomized trials2020Clinical & Translational Oncology

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