apalutamide / Generic mfg. - LARVOL DELTA

The comparison of outcomes between neoadjuvant novel and classical hormonal therapy in patients with locally advanced prostate cancer: a retrospective study. (PubMed, BMC Urol) - "Neoadjuvant NHT resulted in superior pathological responses and PSA responses compared with neoadjuvant CHT in patients with locally advanced prostate cancer. Lower PSA values prior to RP were associated with complete response. Our findings highlighted a significant benefit of neoadjuvant NHT in improving bRFS."

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

Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Weill Medical College of Cornell University | Trial completion date: Oct 2025 ➔ Oct 2026

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

PSMA-PET as a way to choose oligometastatic patients for intermittent androgen deprivation: Extended follow-up of a prospective cohort of patients. (ASCO 2025) - "Distribution across NHA was: abiraterone/prednisone: 21, enzalutamide: 4, apalutamide: 4, abiraterone > enzalutamide: 1 patient. The inclusion of novel technologies on the armamentarium of prostate cancer treatment, including molecular imaging methods, radiation techniques and systemic treatments opens the opportunity to offer more effective and safer treatment modalities and also the need to re-evaluate the rule of intermittent treatment in pre-selected patients. The results of this single-center cohort ambispective analysis are promising, and longer follow-up and future prospective trials are awaited."

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

Comparative efficacy and safety of novel androgen receptor inhibitors in nonmetastatic castration-resistant prostate cancer: A systematic review and Bayesian network meta-analysis. (ASCO 2025) - "This study provides a comparative assessment of NSAAs in nmCRPC, highlighting their variable efficacy across different survival outcomes. Apalutamide demonstrated the greatest benefit in OS and TTPP, while darolutamide was most effective for PFS. Enzalutamide showed superior efficacy in improving MFS."

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

Overall survival following enzalutamide resistance in metastatic castration-sensitive versus metastatic castration-resistant prostate cancer. (ASCO 2025) - "Those with prior use of other ARSIs (abiraterone, apalutamide, or darolutamide) before CRPC were excluded. After ENZA resistance (CRPC 2.0), both mCSPC and mCRPC groups showed similarly poor prognosis, with median OS under 18 months. While taxane-based chemotherapy and alternative ARSIs were commonly used as subsequent treatments, only a small proportion received radionuclide therapy or PARP inhibitors. These findings highlight the urgent need for novel approaches to improve survival in CRPC 2.0."

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

Exploratory biomarker analysis for progression during adaptive androgen deprivation therapy for metastatic castration sensitive prostate cancer. (ASCO 2025) - P1, P2 | "For patients with metastatic castrate sensitive prostate cancer (mCSPC), we previously reported on the feasibility of using serum total PSA and testosterone levels to decide when to stop and restart androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone analog (LHRHa) and or a new hormonal agent (NHA) like abiraterone or apalutamide (PMID: 36358643). Adaptive therapy based on serum PSA and testosterone levels is feasible for mCSPC. High PIP and high ave P/T level are significantly associated with early PSA and radiographic progression in our exploratory analyses. These biomarkers are being tested to improve adaptive therapy in our new mCSPC study (NCT06734130)."

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

Treatment patterns and survival by race among men with metastatic castration-resistant prostate cancer (mCRPC) in the United States: A US electronic medical record database 2020-2023. (ASCO 2025) - "Line of therapy was identified as ARPI, chemotherapy, poly (ADP-ribose) polymerase inhibitors (PARPIs), immunotherapy (pembrolizumab, sipuleucel-T), radiopharmaceuticals (Ra-223, 177Lu-PSMA-RLT), alone or in combination...Overall, ARPI (62%) [abiraterone: 25%; enzalutamide: 24%; apalutamide: 9%; darolutamide 4%] and chemotherapy (22%) [docetaxel 16%; cabazitaxel 6%] were most common first-line treatment (1L Tx) for mCRPC... ARPI and chemotherapy remained the most utilized therapies in mCRPC from 2020 to 2023 in the US. Treatment and survival outcomes did not differ significantly between Whites and AAs in mCRPC. Treatment and survival by race in mCRPC.NE, not evaluable."

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

Comparative outcomes of abiraterone and androgen receptor inhibitors (ARPIs) in metastatic castration-sensitive prostate cancer (mCSPC): A real-world analysis from the TriNetX database. (ASCO 2025) - " Using the TriNetX Research Network (2010–2024), we identified mCSPC patients treated with abiraterone (n=681), enzalutamide (n=252), or apalutamide (n=121) in combination with ADT (91–98% receiving a GnRH analog, primarily leuprolide). Outcomes included the risk of hormone resistance (ICD-10 Z19.2) and a combined endpoint of hormone resistance or docetaxel use... This real-world analysis highlights significant differences in treatment outcomes for mCSPC. Enzalutamide was associated with the highest risk of progression, while apalutamide demonstrated the most favorable outcomes, including higher sustained PSA reductions and lower progression risk. Baseline PSA differences may partially explain these findings."

Clinical • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate 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) - "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

Molecular characterization of CDK12 mutation in Chinese CRPC and its impact on first-line endocrine therapy efficacy. (ASCO 2025) - "Common regimens included Bicalutamide + Goserelin, Abiraterone + Goserelin, Flutamide + Goserelin, and Apalutamide + Goserelin. The study identifies molecular characteristics of CDK12-mutated PC associated with sensitivity or resistance to endocrine therapy. Endocrine-sensitive subtypes are characterized by ARamp, ERBB3amp, GS ≤7, and PSA ≤20 ng/mL, while endocrine-resistant subtypes include TP53, BRCA2, RB1, GS >7, and PSA >20 ng/mL. These findings emphasize the utility of NGS for improving treatment outcomes and predicting first-line endocrine therapy efficacy in CDK12-mutated PC."

Clinical • IO biomarker • Castration-Resistant Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • BRCA2 • CDK12 • ERBB3 • RB1 • TP53

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

Impact of BRCA alterations on androgen receptor pathway inhibition treatment outcome in advanced prostate cancer. (ASCO 2025) - " We conducted a retrospective analysis of pooled data from five randomized clinical trials investigating ARPIs (apalutamide (Apa) or abiraterone acetate (Abi) plus prednisone/prednisolone (Prd)) in metastatic castration sensitive (mCSPC), non-metastatic castration resistant (nmCRPC) or metastatic castration resistant (mCRPC) disease settings. These data show that poorer responses to treatment of BRCA altered patients are also seen when such patients are treated with ARPIs, which underlines the unmet need for new and targeted therapeutic approaches for these patients."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

Corticosteroid (CS) use and risk of adverse events (AEs) in patients (pts) treated for metastatic hormone-sensitive prostate cancer (mHSPC). (ASCO 2025) - "Background: Treatment (Tx) of mHSPC involves intensifying androgen-deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPIs; abiraterone, darolutamide, enzalutamide, apalutamide) with/without docetaxel (D)...Multivariable Cox proportional hazards models were used to evaluate the association between CS exposure (binary time-varying variable, defined as ≥1 daily dose of ≥5 mg prednisone-equivalent CS during the follow-up period) and risk of prespecified AEs and death, adjusted for baseline demographic and clinical characteristics, AEs, and healthcare utilization in the 1 year prior to index, as well as average daily dose of CS over all available times prior to index... Among pts with mHSPC, CS exposure was associated with increased risk of nearly all categories of AEs and death. These data can help guide pt counseling and Tx selection."

Adverse events • Clinical • Metastases • Anemia • Castration-Resistant Prostate Cancer • Congestive Heart Failure • Diabetes • Endocrine Disorders • Genito-urinary Cancer • Heart Failure • Hormone Sensitive Prostate Cancer • Infectious Disease • Metabolic Disorders • Oncology • Ophthalmology • Prostate Cancer • Solid Tumor

Health-related quality of life in metastatic hormone sensitive prostate cancer (mHSPC): Insights from a network meta-analysis of treatment options. (ASCO 2025) - "Darolutamide + ADT showed a significant improvement in time to deterioration in FACT-P total score compared to both ADT monotherapy and apalutamide + ADT, with a favorable trend observed versus both abiraterone + ADT and enzalutamide + ADT. The analysis suggests that darolutamide + ADT may provide HRQoL advantages compared to other ARPIs +ADT. This finding may be an important component of patient-centered treatment decision-making in mHSPC. Results from the HRQoL NMA: Time to deterioration in FACT-P total score.*Hazard Ratio."

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

Real-world treatment patterns, sequences, and outcomes in patients with mCRPC in US urology clinics. (ASCO 2025) - "Of the 1,914 patients treated with androgen receptor pathway inhibitors (ARPIs) pre-mCRPC, including enzalutamide (enza), abiraterone (abi), apalutamide, and darolutamide, 95.8%, were treated with ARPI ± ADT. This data indicates the majority of patients used ADT alone pre-mCRPC. ARPI rechallenge was the most common treatment sequence from pre-mCRPC to mCRPC among ARPI exposed patients. Less than half of the patients analyzed received 2L+ therapy."

Clinical • HEOR • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Prostate Cancer • Urology

Outcomes for patients with SPOP-mutated castration-resistant prostate cancer (CRPC) treated with an androgen receptor pathway inhibitor (ARPI). (ASCO 2025) - "In the AbiRace and PANTHER trials, Black men with metastatic CRPC who received abiraterone +/- apalutamide had improved outcomes suggesting ancestry-based differences in the benefits of single or dual AR pathway inhibitor (ARPI) therapy. In this exploratory analysis, patients with SPOP mutations demonstrated greater PSA declines with an ARPI in the CRPC setting compared to SPOPwt patients but SPOP mutations did not explain the race-survival disparity. Larger data sets with greater diversity are needed to examine SPOP and other ancestral-associated genomic alterations associated with race and outcomes in CRPC patients treated with an ARPI."

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

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 | "Elevated baseline DHEAS levels may have positive predictive significance for rPFS and OS in Black men treated with combination Apa and AA + P compared to White men, but not when treated with AA + P alone. Larger prospective studies are needed. If confirmed, these results support the hypothesis that some Black men may disproportionately benefit from combined androgen signaling pathway inhibition."

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

Apalutamide in patients with metastatic hormone-sensitive prostate cancer: Real-world experience and a retrospective multicenter analysis. (ASCO 2025) - "This real-world analysis highlights the effectiveness of apalutamide plus ADT in mHSPC. A rapid PSA decline (≤0.2 ng/ml or ≤0.02 ng/ml) emerged as a strong predictor of prolonged OS and rPFS, highlighting its potential as a surrogate marker for therapeutic success. These findings reinforce the importance of this combination in optimizing outcomes for patients with mHSPC."

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

Treatment intensification in veterans with metastatic prostate cancer. (ASCO 2025) - "We used multivariable logistic regression to estimate predicted probabilities for treatment intensification (i.e., ADT plus ARPI [abiraterone, enzalutamide, apalutamide, darolutamide] and/or docetaxel) versus ADT alone within six months of metastatic diagnosis. Men with mCSPC had a higher rate of treatment intensification in the VA than prior studies of men with mCSPC in the community; however, rates of treatment intensification remain low, and Black Veterans were still less likely to receive this standard of care despite adjustment for comorbidity, disease characteristics, and other social factors."

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

Intensified hormonal blockade with SBRT in PSMA-PET detected oligometastatic prostate adenocarcinoma: Results from the phase II Metacure trial cohorts B2 and the B2 expansion. (ASCO 2025) - P2 | "Cohort B2 randomized pts to metastasis-directed SBRT with either 10 months of ADT + apalutamide + abiraterone acetate plus prednisone (ADT+APA+AAP) or ADT + apalutamide (ADT+APA). SBRT with short course intensified hormonal blockade was well tolerated and led to durable disease control in pts with PSMA PET-detected metachronous oligometastatic prostate cancer."

Metastases • P2 data • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer

TRIPLE-SWITCH (SWOG/CCTG-PR26): A randomized phase III clinical trial for the addition of docetaxel to androgen receptor pathway inhibitors in patients with metastatic castration sensitive prostate cancer (mCSPC) and suboptimal PSA response (NCT06592924). (ASCO 2025) - P3 | "Arm 1 will continue standard ADT + ARPI (abiraterone acetate with prednisone, apalutamide, enzalutamide or darolutamide). Correlative studies will explore the prognostic and predictive value of circulating tumor DNA (ctDNA) and the association between molecular signatures in primary prostate cancer tissue and clinical outcomes. Enrolment has been initiated in January 2025 and is ongoing."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Triplet versus doublet therapy in older patients with metastatic hormone-sensitive prostate cancer: A network meta-analysis. (ASCO 2025) - "The second NMA analyzed seven treatment options, treating different ARAT agents as independent regimens: two triplets (abiraterone or darolutamide) + ADT + docetaxel, three doublets (abiraterone, enzalutamide, or apalutamide) + ADT, ADT + docetaxel, and ADT alone. Triplet therapy of darolutamide + ADT + docetaxel should be prioritized over other treatment options for fit older patients with mHSPC. Further research utilizing real-world effectiveness data is essential to validate this recommendation."

Metastases • 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) - "Funded by Janssen Scientific Affairs, LLC Background: Phase III studies of dual therapy with an androgen receptor (AR) antagonist, apalutamide (Apa) or enzalutamide (Enza) with abiraterone acetate (AA) plus (+) prednisone (P) in metastatic castration resistant prostate cancer (mCRPC) have not shown a survival benefit vs single agent therapy...Despite the decrease in AA levels, steroids upstream of CYP17A in PANTHER were markedly elevated vs treatment with AA + P alone: pregnenolone (4.1 vs 0.79ng/ml, p=<0.0001), consistent with a suboptimal prednisone-mediated suppression of ACTH Serum AA levels at week 4 are substantially lower, and androgen levels substantially higher, among men with mCRPC treated with Apa and AA + P vs AA + P. Our data suggest that Apa decreased P levels to the point that circulating ACTH remained sufficient to mediate ongoing basal adrenal androgen synthesis... Serum AA levels at week 4 are substantially lower, and androgen levels substantially..."

Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CYP17A1 • CYP3A4

Ceramides and response to dual secondary hormonal therapy in metastatic castration-resistant prostate cancer (mCRPC) among Black men. (ASCO 2025) - P2 | "In our prospective trial of combination therapy with apalutamide (Apa) and abiraterone acetate (AA) plus prednisone (P) among Black and White men with mCRPC (PANTHER, ClinicalTrials.gov identifier NCT03098836), we previously reported the 24-month radiographic progression-free survival (rPFS) for Black and White men were 61% (95% CI 49, 78) and 38% (95% CI 27, 54), while the 36-month overall survival (OS) rates were 68% (95% CI 55, 83) and 50% (95% CI 37, 66), respectively. Our study showed that Cer(d18:1/20:0) associated with prolonged rPFS and OS among Black patients with mCRPC treated with the combination of Apa and AA + P therapy. Pending validation, this distinct ceramide species has potential to serve as a predictive indicator of response to combination Apa and AA + P therapy among Black mCRPC patients. Drug and funding for Abi Race and PANTHER provided by Janssen Scientific Affairs, LLC."

IO biomarker • Metastases • Castration-Resistant Prostate Cancer • Colon Cancer • Colorectal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Substudy C of the Canadian cancer trials group (CCTG) IND.234: PC_BETS (Prostate Cancer Biomarker Enrichment and Treatment Selection)—A phase II study of darolutamide (DARO) selected by androgen-receptor (AR) circulating tumor DNA (ctDNA) in patients (PTS) with metastatic castration-resistant prostate cancer (mCRPC) after prior AR pathway inhibitors (ARPIs). (ASCO 2025) - P2 | "Sixteen pts (22%) had docetaxel for hormone-sensitive disease and none for mCRPC. Prior ARPI were abiraterone (31/72, 43%), enzalutamide (37/72, 51%), or apalutamide (4/72, 6%)... DARO demonstrates modest activity for unselected mCRPC following ARPIs. ctDNA analysis enriched for pts more likely to benefit from DARO including SPOP alterations, AR amp, and AR mutations L702H and T878A."

Biomarker • Circulating tumor DNA • Clinical • Metastases • P2 data • Anorexia • Castration-Resistant Prostate Cancer • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • SPOP