apalutamide / Generic mfg. - LARVOL DELTA

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

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

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

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 CDT"

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 CDT"

Metastases • Real-world • Real-world evidence • Retrospective data • Castration-Sensitive Prostate Cancer • Genito-urinary 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 CDT"

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

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

AZD9750, a novel androgen receptor proteolysis targeting chimera (AR-PROTAC) for the treatment of prostate cancer (AACR 2025) - "Several androgen receptor pathway inhibitors (ARPIs) have been developed and approved for the treatment of locally advanced and metastatic prostate cancer, including the androgen synthesis inhibitor, abiraterone and the AR antagonists, enzalutamide, apalutamide and darolutamide. These data confirm that AZD9750 is a potent oral degrader of AR that leads to anti-tumor efficacy in a range of hormone-sensitive and castrate-resistant PDX models. Through degradation of AR, including mutant and amplified forms of the receptor, it has the potential to overcome key resistance mechanisms arising to current standard of care therapies and provide benefit to patients with prostate cancer."

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

IGFBP3 signaling promotes resistance to next-generation antiandrogens therapeutics in advanced prostate cancer (AACR 2025) - "We hypothesize that IGFBP3 is required for acquired and intrinsic NGAT resistance. Enzalutamide-resistant (MDVR), Abiraterone-resistant (AbiR), Apalutamide-resistant (ApalR), and Darolutamide-resistant (DaroR) C4-2B subline cells exhibit stout NGAT resistance compared to C4-2B parental cells. We demonstrated that increased IGFBP3 expression by NGAT treatment leads to increased sphingolipid metabolism by simultaneously demoting ceramide-induced apoptosis and fostering S1P production through SphK1 activation. Thus, IGFBP3 induces the activation of SphK1 to hijack the sphingosine metabolism to fuel NGAT resistance. Our findings demonstrate that targeting the IGFBP3/SphK1 signaling axis enhances our ability to resensitizes resistant CRPC to NGAT therapeutics."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • IGFBP3 • SPHK1

Establishment and characterization of enzalutamide resistant prostate CDX models (AACR 2025) - "Although the first generation of anti-androgen receptor (AR) new drugs such as flutamide, nilutamide, and bicalutamide were launched few years ago and lighted new hopes for treatment of androgen dependent PCa, drug resistance was developed quickly and push the second generation of anti-AR drugs such as enzalutamide, apalutamide, and darolutamide to the market by their high specific binding to AR and better drug efficacy. Western blot for androgen receptor expression level in tumor tissues and ELISA assay for prostate specific androgen (PSA) level in serum are highly correlated to the tumor volume of C4-2B Enz-R CDX models. The well characterized novel C4-2B Enz-R cell line and CDX model were appropriate for new drug discovery of anti-PCa drugs through AR pathway in vitro and in vivo."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

Cyanobacteria-derived RNA aptamer supports prostate cancer hormone sensitivity (AACR 2025) - "On the other hand, non-metabolizable L-Gln analogues like 6-Diazo-5-oxo-l-norleucine (DON) and DRP104 have shown promising antitumor effects...The L-Gln-depleting aptamer, with demonstrated serum stability, limited the proliferation, and lineage plasticity of the castrate resistant prostate tumors alone and in combination therapy with AR antagonists, enzalutamide and apalutamide in subcutaneous and orthotopic mouse models...Superiority of the functionalized nanoparticle targeting was demonstrated in an orthotopic PCa model over the un-targeted aptamer in reducing tumor weight. The studies demonstrated elevated L-Gln can be necessary and sufficient for castrate resistance, as its depletion sensitizes prostatic tumors to AR inhibition."

Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FGF8 • FOXM1

Establishment and characterization of prostate adenocarcinoma XPDX models from naïve and pretreated patients (AACR 2025) - "Genomic characterization identified KDM6A loss in ST7482, a model from a patient post-apalutamide. We have established and characterized an expanded panel of PAC XPDX models. These models can be utilized as a valuable tool in better understanding prostate cancer and in developing novel therapies for drug-resistant patients."

Clinical • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • AR • KDM6A

The impact of androgen receptor pathway inhibitors as starting treatment in metastatic castration-sensitive prostate cancer on patient outcomes (OASIS Japan). (PubMed, Sci Rep) - "22,559 patients with mCSPC had received relevant treatment of whom 15,797 were included in the analysis: 1167 (5.2%) started on apalutamide (APA) + ADT, 1407 (6.2%) on enzalutamide + ADT, 1262 (5.6%) on abiraterone acetate plus prednisone + ADT, and 11,961 (53.0%) on CAB/ADT alone. In patients with regular PSA assessment, a higher percentage of patients starting with APA + ADT achieved PSA50, PSA90 and undetectable PSA at 3 months compared with CAB/ADT (p < 0.0001, p = 0.0005, p < 0.0001, respectively). Use of APA + ADT as a starting treatment for mCSPC was associated with better clinical outcomes versus traditional CAB or ADT in real-world clinical practice in Japan."

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