apalutamide / Generic mfg. - LARVOL DELTA

Apalutamide-Induced Drug-Induced Hypersensitivity Syndrome/Drug Reaction With Eosinophilia and Systemic Symptoms Involving Reactivation of Human Herpesvirus-6 and Cytomegalovirus: A Case Report. (PubMed, J Dermatol) - No abstract available

Journal • Cytomegalovirus Infection • Eosinophilia • Epstein-Barr Virus Infections • Immunology

Predictive associations between serum dehydroepiandrosterone sulfate (DHEAS) and race among patients (pts) treated with apalutamide (apa), abiraterone acetate (AA) plus prednisone (P) in the PANTHER study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT03098836 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Genito-urinary Cancer • Oncology • Penile Cancer • Prostate Cancer • Solid Tumor • Testicular Cancer

Apalutamide in patients with metastatic hormone-sensitive prostate cancer: Real-world experience and a retrospective multicenter analysis. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Metastases • Real-world • Real-world evidence • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Suboptimal suppression of serum androgen levels among men treated with apalutamide and abiraterone acetate plus prednisone compared with abiraterone acetate plus prednisone alone. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Genito-urinary Cancer • Oncology • Penile Cancer • Prostate Cancer • Solid Tumor • Testicular Cancer

STEERLife announces its solvent-free melt fusion technology (ExpressPharma) - "STEERLife, the life sciences division of STEER World, is advancing the development and manufacturing of potent and complex drug products. At the core of this advancement is STEERLife’s solvent-free melt fusion technology, a continuous processing system that eliminates the need for harmful organic solvents....STEERLife has already initiated the development of several key drug products set for market release from 2026 onwards. These include generic versions of ERLEADA (Apalutamide), XTANDI (Enzalutamide), VENCLEXTA (Venetoclax), and LYNPARZA (Olaparib)."

Generic launch • Oncology

Relugolix in Combination with Androgen Receptor Pathway Inhibitors in the Treatment of Metastatic Prostate Cancer: A Clinical Perspective. (PubMed, Target Oncol) - "This review explores the real-world data and clinical studies evaluating relugolix coadministration with ARPIs, including enzalutamide, abiraterone, apalutamide, and darolutamide. However, clinical studies and real-world studies suggest that relugolix maintains testosterone suppression when combined with ARPIs even if administered in a standard dose. While these findings support the efficacy and safety of relugolix-based combination therapy, further large-scale prospective trials are needed to refine treatment recommendations and provide information on long-term outcomes."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CYP3A4

Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Aug 2025

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

Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Mayo Clinic | N=120 ➔ 220

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

Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer (clinicaltrials.gov) - P2 | N=2 | Terminated | Sponsor: Rahul Aggarwal | Active, not recruiting ➔ Terminated; Funding

Trial termination • Castration-Resistant Prostate Cancer • Endocrine Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • RB1 • SYP

Overall survival in patients with metastatic castration-sensitive prostate cancer treated with apalutamide versus abiraterone acetate: a head-to-head analysis of real-world patients in the USA. (PubMed, J Comp Eff Res) - "At 24 months post-index, patients in the apalutamide cohort had a 26% lower risk of mortality compared with those in the abiraterone acetate cohort (hazard ratio: 0.74; 95% confidence interval: 0.59, 0.93; p = 0.010), with the difference maintained when outcomes were evaluated using all available follow-up (hazard ratio: 0.72; 95% confidence interval: 0.59, 0.88; nominal p < 0.001). In this nationally representative, real-world head-to-head analysis of nearly 4000 ARPI-naive patients with mCSPC, apalutamide was associated with a 26% reduction in the risk of mortality compared with abiraterone acetate by 24 months post-treatment initiation."

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

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-GU 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

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=3017 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

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

Apalutamide-induced severe hypothyroidism in a patient treated with levothyroxine: new data on the impact of apalutamide on thyroid hormone metabolism. (ESPE-ESE 2025) - "Eight months later, apalutamide (240 mg/day) associated with triptorelin (GnRH agonist intramuscular injections every 3 months) treatment was started for his metastatic prostate cancer. No adverse events were observed during the test. In conclusion, apalutamide treatment worsened hypothyroidism via decreased levothyroxine absorption and increased T4 clearance in this patient, explaining the higher prevalence of refractory hypothyroidism in levothyroxine-treated patients during apalutamide treatment."

Clinical • Endocrine Disorders • Genito-urinary Cancer • Grave’s Disease • Oncology • Prostate Cancer • Solid Tumor • AR

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer (clinicaltrials.gov) - P1 | N=213 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jun 2025 ➔ Jun 2026

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

Clinical outcomes of treatment intensification in metastatic hormone-sensitive prostate cancer: A multidisciplinary single-center experience (ESTRO 2025) - "Systemic treatments included apalutamide (38.2%), enzalutamide (19.6%), abiraterone (11.1%), and docetaxel (8%), with 3.1% ADT monotherapy, and 7.6% receiving triplet therapy with darolutamide or 3.1% with abiraterone. This real-world study from a single center shows the efficacy of ADT combined with NTH in achieving deep PSA responses and improving survival in mHSPC patients. Deep PSA nadir and low-volume disease were identified as a key biomarker for better outcomes. The manageable toxicity profile of NHT supports their application into our clinical practice."

Clinical • Clinical data • Metastases • Cardiovascular • Genito-urinary Cancer • Hematological Disorders • Hormone Sensitive Prostate Cancer • Hypertension • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia • Urology

Real World Treatment Patterns for Castration-Sensitive Prostate Cancer Between 2012 and 2024: A Systematic Review (ISPOR 2025) - "The review focused on ADT usage, including combinations with docetaxel and/or NHTs (abiraterone, apalutamide, enzalutamide, and darolutamide) or with other treatments. This review offers healthcare providers valuable insights into CSPC treatment trends. The findings aim to refine clinical guidelines, inform policymaking, improve resource allocation, and enhance market understanding globally."

Clinical • HEOR • Real-world • Real-world evidence • Review • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Real World Treatment Patterns, Genetic Testing, and Clinical Outcomes among Patients with mCRPC Treated with Olaparib Monotherapy in US Urology Clinics (ISPOR 2025) - "OBJECTIVES: Olaparib is an approved PARP inhibitor (PARPi) for treating metastatic castration-resistant prostate cancer (mCRPC), in patients with HRR mutations (HRRm) following treatment with abiraterone acetate with prednisone (abi) or enzalutamide (enza)...Previous pre-mCRPC therapies included androgen receptor pathway inhibitors (ARPIs) (abi, enza, apalutamide and darolutamide) in 45% of the cohort... This study highlights contemporary real-world treatment and testing patterns, and clinical outcomes associated with HRRm mCRPC patients treated with olaparib monotherapy. This data suggests the opportunity for earlier treatment with olaparib monotherapy which may improve rwOS in patients with mCRPC whose disease has progressed after receiving an ARPI."

Clinical • Clinical data • HEOR • Monotherapy • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology • BARD1 • BRCA • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK1 • FANCL • PALB2 • RAD51B • RAD51C • RAD51D • RAD54L

Real-world effectiveness of darolutamide in metastatic castration-resistant prostate cancer. (PubMed, Endocr Relat Cancer) - "Its real-world effectiveness in the treatment of patients with metastatic (M1) CRPC, including those who have progressed on CYP17 inhibitors (CYP17Is) or other 2GARAs (enzalutamide/apalutamide) is not well-described. In summary, darolutamide may provide some benefit in CYP17I-refractory M1-CRPC patients, even in the presence of AR mutations. Resistance to other 2GARAs may significantly decrease benefit from darolutamide."

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

A Cyanobacteria-derived RNA aptamer resensitizes prostate cancer to hormone therapy. (PubMed, Cancer Res) - "Accordingly, the L-Gln-depleting aptamer, with demonstrated serum stability, limited the proliferation and promoted cell death of castration-resistant PCa alone and in combination therapy with AR antagonists, enzalutamide and apalutamide, in subcutaneous and orthotopic mouse models. The functionalized nanoparticle demonstrated superior anti-tumor efficacy in an orthotopic PCa model over the untargeted aptamer. The anti-tumor activity of the aptamer helped support L-Gln as an oncometabolite in PCa that can be targeted to sensitize tumors to hormone therapy."

Journal • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • FGF8 • FOXM1

Real-world clinical outcomes of apalutamide versus abiraterone with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer. (PubMed, Int J Clin Pharm) - "Apalutamide demonstrated deeper and more sustained PSA reductions, translating into delayed disease progression compared to abiraterone. Both treatments were generally well tolerated, though adverse events were more prevalent with apalutamide."

Clinical data • Journal • Real-world evidence • Castration-Sensitive Prostate Cancer • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Enhancing chemotherapy efficacy in PTEN-deficient prostate tumors with targeted AKT inhibition (AACR 2025) - "Capivasertib is currently being evaluated in a Phase 3 trial (CAPItello-280) along with docetaxel (Dtx) for the treatment of patients with mCRPC...Mice with tumors treated with Dtx+ capivasertib after progression to androgen deprivation therapy (surgical castration) and apalutamide had longer survival and longer tumor doubling times than those treated with Dtx alone. In conclusion, PTEN-deficient CRPC is less sensitive to Dtx than HSPC. However, our model showed that adding capivasertib to Dtx suppressed tumor growth and improved the therapeutic efficacy of CRPC."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AKT1S1 • CASP3 • PTEN • TP53

Apalutamide, ADT and stereotactic radiotherapy (AD ASTRA) phase II study in high-risk prostate cancer: study design and preliminary safety analysis (ESTRO 2025) - "AD ASTRA study protocol allows systemic and local treatment intensification for men with high-risk PCa. We observed high adherence and no new safety signals were identified for the combination of apalutamide with ADT and prostate and pelvic SBRT."

Clinical • P2 data • Cardiovascular • Dermatology • Endocrine Disorders • Gastrointestinal Disorder • Genito-urinary Cancer • Hypertension • Oncology • Prostate Cancer • Solid Tumor

PERSIAN TRIAL (NCT03449719): Apalutamide and stereotactic body radiation therapy in patients affected by hormone-sensitive prostate cancer (ESTRO 2025) - P2 | "In metastatic castrate resistant prostate cancer (mCRPC), addition of stereotactic body radiotherapy (SBRT) to abiraterone acetate, another androgen receptor pathway inhibitor (ARPI), showed to provide significant benefit in terms of clinical outcomes [2]. Experimental arm had a non significant trend in terms of early complete biochemical response rate (27% odds increase if compared to control arm). Increased benefit was evidenced in patients with <3 metastases. Accrual will be completed within the end of 2024, and early results about the 6 months follow up of the complete cohort will be available in the second half of 2025."

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

Intercepting bladder cancer progression using androgen receptor inhibitor, apalutamide, in a carcinogen BBN-induced rat bladder tumor model (AACR 2025) - "Biomarker analysis showed reduction in the proliferation markers Ki67 and cyclin D1 in apalutamide treated rats tumors. In conclusion, our study demonstrated that an AR antagonist, apalutamide, can intercept bladder tumor growth and progression in a preclinical rat model and warrants further investigation in clinical trials.(Project funded 100% with Federal funds from NCI, NIH, DHHS, under Contract 75N91019D00020_75N91022F00002)"

Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CCND1

Discovery of a novel class of androgen-competitive AR inhibitors that can combat drug resistance due to AR gene amplification (AACR 2025) - "Enzalutamide ushered in the current generation of approved ARi and was identified using prostate cancer cell line models of bicalutamide resistance with increased AR protein...At higher levels of AR, enzalutamide, apalutamide, and darolutamide show the same agonist conversion and corresponding evidence of incomplete antagonism in enzalutamide-resistant prostate cancer cells with high copy AR amplification...These observations suggest that the potential for a switch to agonism is inherent, in the 'lutamide scaffold, and is exacerbated by increased AR levels leading to incomplete antagonism and resistance. This resistance can be effectively combated with a new class of complete AR antagonists."

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