apalutamide / Generic mfg. - LARVOL DELTA

LIBERTAS: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (clinicaltrials.gov) - P3 | N=420 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

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

Johnson & Johnson Lifts Annual Forecast After Strong Cancer Drugs, Medtech Performance (Benzinga) - "The pharmaceutical giant reported sales of $23.74 billion, up 5.8% year over year and beating the consensus of $22.85 billion. Operational growth was 4.6%, and adjusted operational growth was 3%...Growth was driven by Darzalex (daratumumab)...Erleada (apalutamide), Rybrevant/Lazcluze in oncology...Cancer sales increased to $6.31 billion, up 24% (+22.3% operational)....Darzalex sales rose 23% to $3.54 billion."

Sales • Hormone Sensitive Prostate Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Prostate Cancer

Healthcare resource utilization and costs among patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or enzalutamide in the United States (2019-2023). (PubMed, J Med Econ) - "While linkages between the data sources are comprehensive, any mis-linkages may have led to misclassification and information bias. The findings of this study suggest that apalutamide may result in better economic outcomes relative to enzalutamide."

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

TMPRSS2 Expression in Lung Tissue of Prostatic Adenocarcinoma Patients: A Pathologic Perspective on Androgen Deprivation Therapy. (PubMed, medRxiv) - "Direct AR antagonists (apalutamide, bicalutamide) produced more pronounced TMPRSS2 suppression than GnRH modulators or androgen biosynthesis inhibitors. Our findings demonstrate that ADT significantly reduces pulmonary TMPRSS2 expression, with direct AR antagonists showing the strongest effect. This suggests a potential mechanistic explanation for differential COVID-19 susceptibility and provides rationale for investigating AR-targeted therapies as potential protective interventions against SARS-CoV-2 infection severity."

Journal • Genito-urinary Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Respiratory Diseases • Solid Tumor • AR • TMPRSS2

Phenotypic Plasticity and Androgen Receptor Bypass Drive Cross-Resistance to Apalutamide in Castration-Resistant Prostate Cancer Cell Models. (PubMed, Int J Mol Sci) - "The treatment of choice for prostate cancer is androgen deprivation (ADT) and novel hormonal agents such as Abiraterone, Enzalutamide, or Apalutamide. Most CRPC cell models developed cross-resistance to Apalutamide and were able to proliferate and retain their clonogenic capability. Apalutamide resistance was not linked to the expression of AR-V7 or AR-V9 variants but was instead associated to bypass of AR signaling pathway and the emergence of more aggressive expression profiles."

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

Apalutamide and Stereotactic Body Radiotherapy in Metastatic Hormone-Sensitive Prostate Cancer: Multicenter Real-World Study. (PubMed, Cancers (Basel)) - "The combination of apalutamide and SBRT in mHSPC is associated with high local and systemic disease control and minimal toxicity in a real-world setting. This approach may delay systemic treatment intensification and the onset of castration resistance. Prospective studies are warranted to confirm these findings."

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

Evaluating Treatment Efficacy in Metastatic Hormone-sensitive Prostate Cancer Patients with Visceral Disease: A Systematic Review and Network Meta-analysis. (PubMed, Eur Urol Oncol) - "Treatment intensification with triplet therapy (ADT + docetaxel + darolutamide) provides the greatest OS benefit in mHSPC patients with VD. Doublet regimens incorporating chemotherapy or abiraterone remain viable alternatives. Further prospective studies are needed to refine treatment selection based on VD-specific biology and organ-specific metastatic patterns."

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

Metformin for patients with metastatic prostate cancer starting androgen deprivation therapy: a randomised phase 3 trial of the STAMPEDE platform protocol. (PubMed, Lancet Oncol) - P2/3 | "We did not find significant evidence of an overall survival benefit of adding metformin to standard of care in the overall population of patients with metastatic hormone-sensitive prostate cancer. The side-effect profile of metformin was as expected and consisted mainly of diarrhoea. Adverse metabolic side-effects of ADT were significantly reduced in the metformin group compared with the standard of care group."

Journal • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

(Methyl)thianthrenium Salt Enabled Monoselective N-Methylation and N-(13C-Methyl) Labeling: Late-Stage Functionalization of Arylamides. (PubMed, Org Lett) - "The versatility and broad applicability of this approach are demonstrated through the successful synthesis of marketed drugs such as enzalutamide and apalutamide. Its operational simplicity, versatility, selectivity, and scalability make this protocol an efficient tool for late-stage diversification and isotope labeling of amide-based scaffolds."

Journal

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

Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy (clinicaltrials.gov) - P2 | N=45 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial primary completion date: Mar 2026 ➔ Oct 2024

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

Final analysis of ArtemisR, a European real-world retrospective study of apalutamide for the treatment of patients with metastatic hormone-sensitive prostate cancer. (PubMed, BMC Cancer) - "The ArtemisR European multi-centre study examined the efficacy and safety of apalutamide plus ADT for patients with mHSPC, further validating the deep and fast PSA response associated with this treatment regimen. These real-world outcomes were additionally observed in a more diverse patient population than that included in the pivotal TITAN study."

Journal • Observational data • Real-world evidence • Retrospective data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Low-dose Apalutamide in Non-metastatic Castration-resistant Prostate Cancer: A Case Series. (PubMed, Anticancer Res) - "Low-dose apalutamide was effective in this 6-patient case series. While awaiting new dose-response studies, we propose an apalutamide dose prescription flowchart that can be adapted for individual patients to avoid exposure to higher doses of the drug."

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

ArtemisPRO: A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide (clinicaltrials.gov) - P=N/A | N=516 | Active, not recruiting | Sponsor: Janssen-Cilag Ltd. | Recruiting ➔ Active, not recruiting

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

Do Older Patients With Metastatic Hormone-Sensitive Prostate Cancer Benefit From Triplet or Doublet Therapy? A Network Meta-Analysis. (PubMed, Clin Genitourin Cancer) - "In older patients with mHSPC, triplet therapy comprising darolutamide, ADT, and docetaxel demonstrated the most pronounced OS benefit and ranked highest among currently available treatment options. Further studies are needed to explore the specific toxicities associated with the triplet regimen in this population to better balance oncologic benefits with treatment-related toxicities when making treatment decision."

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

APEX-01: ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer (clinicaltrials.gov) - P1 | N=253 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2026 ➔ Dec 2028 | Trial primary completion date: May 2026 ➔ Jun 2027

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

Pooled Analysis of the SOLAR and SATURN Clinical Trials Comparing Progression of Synchronous Versus Metachronous Prostate-specific Membrane Antigen-defined Oligometastatic Prostate Cancer Following Systemic and Tumor-directed Therapy. (PubMed, Eur Urol Oncol) - P2 | "All patients received 6 mo of intensified systemic therapy (leuprolide, abiraterone acetate with prednisone, and apalutamide) and stereotactic body radiotherapy to oligometastases. Among 50 patients (24 synchronous and 26 metachronous), the synchronous omCSPC group had a significantly higher PSA response rate (83% vs 50%; p = 0.018) and significantly longer PFS and eugonadal PFS (p < 0.05). The metachronous subgroup with prior ADT had worse outcomes, suggesting increasing resistance with repeated systemic therapy."

Journal • Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TherApeutics in Early ProState Cancer (TAPS02) (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Cambridge University Hospitals NHS Foundation Trust | Phase classification: P3 ➔ P2 | N=402 ➔ 90 | Trial completion date: Apr 2031 ➔ Oct 2029 | Trial primary completion date: Apr 2031 ➔ Oct 2029

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ultralow Prostate-specific Antigen Nadir After Apalutamide: Outcomes in Synchronous Versus Metachronous Metastatic Hormone-sensitive Prostate Cancer. (PubMed, Eur Urol Open Sci) - "This applies to patients with metastasis when they are first diagnosed and to patients who develop metastasis after their diagnosis of prostate cancer. This level of ≤0.02 ng/ml can be used in discussing prognosis and treatment options with these patients."

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

Thrombosis risks in prostate cancer patients on oral anticoagulants and enzalutamide/apalutamide (ISTH 2025) - "We compared patents with concurrent prescription of a DOAC to non-DOAC (including low-molecular-weight heparin [LMWH] or warfarin). Additional analyses using death as competing risk and after excluding patients with VTE within 6 months of index revealed consistent results (Table 2). Table or Figure Upload"

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Thrombosis • Venous Thromboembolism • CYP3A4

Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: A real-world prostate cancer disease observation (PRECISION) data platform analysis. (ASCO 2025) - "Guideline-recommended therapies included abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, and radium-223. In this real-world analysis, the majority of patients who received guideline-recommended therapies after 177Lu-PSMA-617 achieved at least a PSA50 response, suggesting that 177Lu-PSMA-617 treatment does not preclude response to other subsequent therapies."

Clinical • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

PETRANHA: Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=190 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jul 2031 ➔ Apr 2031 | Trial primary completion date: Jul 2031 ➔ Apr 2031

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

Intensification of androgen deprivation therapy (ADT) in metastatic hormone sensitive prostate cancer (mHSPC): Patterns of use and impact on outcomes from a large academic medical center. (ASCO 2025) - "Funded by No funding sources reported Background: ADT intensification with docetaxel and/or androgen receptor pathway inhibitors (ARPIs) has survival benefit in mHSPC...Leuprolide (85.3%), relugolix (12.1%) or degarelix (2.7%) were used for ADT. Of those who RI, 80.3% received an ARPI; 62.3% received abiraterone, 14.6% darolutamide, 13.9% apalutamide, and 9.3% enzalutamide... While PFS was longer for those who RI, these pts also had higher volume of disease, higher PSA, and higher rates of de novo disease, likely contributing to poorer OS. Even at a large academic institution, only about half of pts received intensification. Pts not given intensification were older, and patient preference was the most commonly identified reason for not receiving intensification."

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

Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy (clinicaltrials.gov) - P2 | N=118 | Completed | Sponsor: Dana-Farber Cancer Institute | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Jul 2024

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

Diabetes and Acute Care Use Among Patients With Metastatic Prostate Cancer Treated With Androgen Receptor Signaling Inhibitors. (PubMed, JCO Oncol Pract) - "Acute care use was common among patients with metastatic prostate cancer on ARSIs. Patients with diabetes experienced higher rates of acute care use compared with those without diabetes among all ARSI types. Future studies should assess potential interventions in older patients with diabetes on ARSIs."

Journal • Diabetes • Genito-urinary Cancer • Metabolic Disorders • Oncology • Prostate Cancer • Solid Tumor