apalutamide / Generic mfg. - LARVOL DELTA

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), NCCN Guidelines Navigator, and the NCCN Radiation Therapy Compendium for Prostate Cancer, Version 1.2026. (NCCN)

NCCN guideline • Castration-Resistant Prostate Cancer

Pembrolizumab for treatment-related neuroendocrine prostate carcinoma with a high tumor mutational burden: a case report. (PubMed, Front Oncol) - "We present the case of a 66-year-old man with metastatic prostate cancer (adenocarcinoma with a Gleason score of 4 + 5, initial prostate-specific antigen [PSA] level of 267 ng/mL, clinical stage T3bN0M1b) who was initially treated with doublet therapy, including apalutamide and leuprorelin, leading to a reduction in circulating levels of PSA < 0.001 ng/mL. At the 41-month after diagnosis, a 75% reduction in the retroperitoneal mass and a decrease in NSE levels to 31 ng/mL were observed. This case suggests that pembrolizumab is a potential treatment option for t-NEPCs with TMB-high."

Journal • Tumor mutational burden • Genito-urinary Cancer • Genitourinary Neuroendocrine Carcinoma • Oncology • Prostate Cancer • Solid Tumor • TMB

Integrated multi-omics profiling of immune microenvironment and drug resistance signatures for precision prognosis in prostate cancer. (PubMed, Cancer Drug Resist) - "ScRNA-seq delineated three PCa cell clusters, with high-risk subtypes being sensitive to bendamustine/dacomitinib and resistant to apalutamide/neratinib. This study establishes a TME-driven prognostic framework that connects immune heterogeneity, genomic instability, and therapeutic resistance in PCa. By pinpointing metabolic dependencies and subtype-specific vulnerabilities, our findings provide actionable strategies to circumvent treatment failure, such as targeting energy metabolism or tailoring therapies based on resistance signatures."

Journal • Tumor mutational burden • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MUC5B • TMB • TP53

A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=1300 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Reassessing the Evidence: Is Intensified Therapy Justified in Older Patients with Metastatic Hormone-Sensitive Prostate Cancer? (PubMed, Clin Genitourin Cancer) - "Eligible studies combined androgen deprivation therapy (ADT) with docetaxel, abiraterone, enzalutamide, apalutamide, darolutamide, or antiandrogens. Treatment decisions in this population should be individualized using geriatric assessment, considering patient fitness, comorbidities, life expectancy, and treatment goals. Further dedicated trials in older and frail patients are warranted to guide optimal therapeutic strategies."

Journal • Review • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

PETRANHA: Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=175 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Apr 2031 ➔ Apr 2026 | Trial primary completion date: Apr 2031 ➔ Apr 2026

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

A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely (clinicaltrials.gov) - P=N/A | N=13779 | Completed | Sponsor: Bayer | Active, not recruiting ➔ Completed

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

Comparative neurological safety of novel hormonal therapies in advanced prostate cancer: a Bayesian network meta-analysis of randomized trials. (PubMed, Int J Clin Oncol) - "Although no NHA significantly increased neurological AEs, enzalutamide showed the highest estimated risk, while darolutamide and NSAAs ranked best for neurological safety. Darolutamide may be preferred in elderly patients, highlighting the need for further long-term safety data."

Journal • Retrospective data • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Triplet systemic therapy for hormone-sensitive prostate cancer: a critical review with a multidisciplinary approach. (PubMed, Oncol Rev) - "This article aims to critically evaluate the evidence for triplet therapy consisting of androgen deprivation therapy (ADT), docetaxel and a second-generation androgen receptor pathway inhibitor ([ARPI]; abiraterone, enzalutamide, darolutamide or apalutamide) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), and what this evidence reveals regarding the use of these treatments in clinical practice. Darolutamide-based triplet therapy may also be of benefit in other patients with high- or low-risk disease. Careful consideration of the risks and benefits are required to determine which patients can be spared from receiving docetaxel and rather be treated with alternative regimens."

Journal • Review • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Unveiling Ligand-Induced Conformational Changes in Mutant AR-LBD: Molecular Dynamics Insights into the Androgen Receptor-Coactivator Mechanism. (PubMed, J Chem Inf Model) - "Antagonists such as apalutamide, bicalutamide, and enzalutamide inhibit AR activation and are used to treat PCa. The study suggests that point mutations in AR-LBD induce a shift from an antagonistic to an agonistic state by altering the AR and AF-2 structure, resulting in continuous coactivator recruitment and sustained AR activity. Through the application of a dynamic cross-correlation matrix, principal component analysis, free energy landscape computation, and structural community analysis, this research offers valuable insights into AR-coactivator interactions, paving the way for more effective treatments against castration-resistant prostate cancer."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

Bioequivalence and Food Effect Assessment of Apalutamide Tablets Relative to Erleada in Healthy Chinese Male Participants. (PubMed, Clin Pharmacol Drug Dev) - "No serious adverse events occurred during the study, and both formulations were well tolerated under fasted and fed conditions. The test and reference formulations of apalutamide were demonstrated to be bioequivalent under both fasted and fed conditions, and were well tolerated with favorable safety profiles."

Journal • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Scaling the side effects: A case of apalutamide-induced ichthyosis. (PubMed, JAAD Case Rep) - No abstract available

Adverse events • Journal • Atopic Dermatitis • Dermatology • Immunology • Vitiligo

CHAMPION study (NCT05717582) : a prospective study of maximal-cytoreductive therapies for patients with de novo metastatic hormone-sensitive prostate cancer who achieve oligopersistent metastases during systemic treatment with apalutamide plus androgen deprivation therapy (ESMO 2025) - P2 | No abstract available

Clinical • Metastases • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Early Results from a Randomized Phase II Trial Testing Apalutamide and Stereotactic Body Radiation Therapy for Low-Burden Mhspc (NCT05717660) (ASTRO 2025) - P2 | No abstract available

Clinical • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Preliminary safety and clinical activity from a phase II study of apalutamide + carotuximab in advanced, castration-resistant prostate cancer (ESMO 2025) - No abstract available

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-world data explores benefits of apalutamide in metastatic hormone-sensitive #ProstateCancer. @maughanonc @huntsmancancer joins @zklaassen_md @GACancerCenter to talk about the #OASIS project, examining real-world outcomes with first-line apalutamide treatment in #mHSPC. #WatchNow > http://bit.ly/43YDcbd

Apalutamide Monotherapy in Metastatic Hormone-Sensitive Prostate Cancer: A Viable Alternative to First-Generation Anti-Androgen Agents to Avoid the Flare Phenomenon and an Effective Treatment for Achieving Early PSA Response. (PubMed, Cancers (Basel)) - "No significant difference in PSA and testosterone level reduction during treatment emerged between subgroups of patients with low- vs. high-volume disease. Apalutamide alone is a viable option for mitigating the flare-up phenomenon, avoiding first generation anti-androgen therapy, and it can achieve rapid and deep biochemical control."

Journal • Monotherapy • Cardiovascular • CNS Disorders • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Musculoskeletal Pain • Oncology • Pain • Prostate Cancer • Solid Tumor

Physiologically Based Pharmacokinetic Modeling to Assess Perpetrator and Victim Cytochrome P450 2C Induction Risk. (PubMed, Pharmaceutics) - " In this study, the authors utilized an all-human hepatocyte triculture system to capture CYP2C induction using the perpetrators rifampicin, efavirenz, carbamazepine, and apalutamide. The MSM approach predicted the CYP3A4 induction-based DDI risk accurately but could not capture CYP2C induction with similar precision. Overall, this is the first study that demonstrates the utility of PBPK modeling as a complementary approach to MSM for CYP2C induction-based DDI risk assessment."

Journal • PK/PD data • CYP2C19 • CYP2C9 • CYP3A4

A Double-Blinded Placebo-Controlled Biomarker Stratified Randomized Trial of Apalutamide (APA) and Radiotherapy for Recurrent Prostate Cancer (NRG GU006, BALANCE trial) (ASTRO 2025) - No abstract available

Biomarker • Clinical • Late-breaking abstract • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treating apalutamide-induced toxic epidermal necrolysis with adalimumab and baricitinib in a patient with prostate cancer (EADV 2025) - No abstract available

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Steven-Johnson Syndrome

A machine learning model (Sol_ME) assisted development of a unit-dose lipid formulation for apalutamide: formulation, pharmacokinetics, and pharmacodynamics evaluation. (PubMed, Int J Pharm) - "This AI-guided, lipid-based system offers an efficient, patient-friendly alternative for apalutamide administration."

Journal • PK/PD data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Apalutamide - Induced Acquired Ichthyosis in an elderly patient: A case report (EADV 2025) - No abstract available

Case report • Clinical • Atopic Dermatitis • Dermatology • Immunology • Vitiligo

Association of Race and Survival in Apalutamide Treated Patients from the TITAN and SPARTAN Phase 3 Trials (ESMO 2025) - No abstract available

Clinical • P3 data • Oncology

A randomized study of apalutamide in Chinese patients with non-metastatic castration-resistant prostate cancer. (PubMed, iScience) - "Grade 3 and 4 treatment-emergent adverse events were reported in 43.1% and 4.2% of patients, respectively, with hypertension, pneumonia, and rash being the most frequently reported, and the safety profile was consistent with existing data on apalutamide. Overall, these findings indicate that apalutamide is both efficacious and safe for Chinese patients, providing a valuable treatment option for high-risk NM-CRPC."

Journal • Cardiovascular • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hypertension • Infectious Disease • Oncology • Pneumonia • Prostate Cancer • Respiratory Diseases • Solid Tumor

Statin Use in Patients With Advanced Prostate Cancer in the TITAN and SPARTAN Trials. (PubMed, JAMA Netw Open) - "In this cohort study, statin exposure was associated with longer OS in patients treated with apalutamide. Statin-exposed patients had a higher risk of grade 3 or greater cardiac AEs, which may reflect their preexisting cardiovascular comorbidity."

Clinical • Journal • Cardiovascular • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor