apalutamide / Generic mfg. - LARVOL DELTA

Evaluating Clinical Tools to Monitor Cardiovascular Risk in Men With Prostate Cancer Receiving Hormone Therapy. (PubMed, JCO Oncol Pract) - P2 | "After 6 months of ADT plus ARPI, men with prostate cancer showed worsening lipid profiles and 21% had worsening of their CV risk based on general population tools. These findings highlight the unmet need to develop prostate cancer-specific CV risk assessment tools."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Genito-urinary Cancer • Metabolic Disorders • Oncology • Prostate Cancer • Solid Tumor

Lichenoid drug reaction induced by apalutamide: report of three cases and review of the literature. (PubMed, Ann Dermatol Venereol) - No abstract available

Journal

The Impact of Early Modification of Upfront Androgen Receptor Signaling Inhibitors on Survival Outcomes in Metastatic Hormone-Sensitive Prostate Cancer. (PubMed, Prostate) - "Early withdrawal of initial upfront ARSI was associated with poor CRPC-FS and PFS2 among mHSPC patients. Maximizing the effectiveness of first-line treatment requires optimal management of ARSI therapy."

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

"The National Prostate Cancer Registry (ProNAT) by d-uo: Three-Year Tumor Data" (DGHO 2025) - "The most common androgen deprivation therapy (ADT) was leuprorelin (52%)...A total of 68% received a new hormonal agent (NHA), most commonly apalutamide, and 32% were treated with docetaxel-based chemotherapy. The ProNAT registry provides comprehensive and up-to-date real-world data on prostate cancer management in Germany. The ProNAT registry provides comprehensive and up-to-date real-world data on prostate cancer management in Germany. These insights were previously unavailable and will support further optimization of prostate cancer care. The project is ongoing."

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

PSMACare trial-in-progress: a phase II trial of [177Lu]Lu-PSMA-617 with or without ARPI in patients with PSMA-positive non-metastatic castration-resistant prostate cancer (ESMO 2025) - P2 | "Participants (N = ∼120) will be randomized 1:1 to receive 177 Lu-PSMA-617 (7.4 GBq q6w, up to 6 cycles) or 177 Lu-PSMA-617 + ARPI (apalutamide, darolutamide or enzalutamide); ADT must be ongoing in both arms. Legal entity responsible for the study Novartis. Funding Novartis."

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

French recommendations from the AFU Cancer Committee for prostate cancer 2025 Summary of changes. (PubMed, Fr J Urol) - "This 2025 summary of changes of French recommendations on PCa should help physicians to stay up-to-date with recent evolutions and aim to improve the management of PCa patients."

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

TRIPLE-SWITCH(SWOG/CCTG-PR26): Randomized Phase III Clinical Trial of Docetaxel with Androgen Receptor Pathway Inhibitors for Metastatic Castration-Sensitive Prostate Cancer Patients with a Suboptimal PSA Response (PCF 2025) - P3 | "Participants are randomized to one of two arms: ▪ Arm 1: Patients will continue on standard ADT + ARPI (abiraterone acetate with prednisone, apalutamide, enzalutamide, or darolutamide). SPL: Aura Bioscience, FKD, JBL (SWOG), Genentech (SWOG), Merck (Alliance), QED Therapeutics, Surge Therapeutics, Vaxiion, Viventia. Consultant/Advisory Board:Aura Bioscience, BMS, C2iGenomics, Ferring, Immunity Bio, Incyte, Gilead, Pfizer/EMD Serono, Protara, Surge Therapeutics, Tyra Biosciences, UroGen, Vaxiion, Verity; Patent – TCGA classifier; Honoraria – Grand Rounds Urology, UroToday"

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

Comparative effectiveness of androgen receptor pathway inhibitor treatment intensification for metastatic hormone-sensitive prostate cancer in real-world patients. (PubMed, Investig Clin Urol) - "Abiraterone acetate, apalutamide, and enzalutamide showed comparable PFS to mCRPC outcomes, while significant differences in early PSA kinetics were observed, with early PSA response serving as a crucial prognostic factor in mHSPC patients."

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

Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. (PubMed, Lancet Oncol) - P2/3 | "Dual inhibition of CDK4 and CDK6 and the androgen receptor pathway with abemaciclib plus abiraterone did not improve radiographic progression-free survival compared with abiraterone alone in the CYCLONE 2 study population with mCRPC. Safety of the combination was consistent with the previously reported safety of the individual drugs. Additional research is required to identify effective combination therapies for patients with mCRPC, especially in those presenting with adverse prognostic characteristics."

Clinical • Journal • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Hormone Sensitive Prostate Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • AR • CDK6

Cost-effectiveness analysis of second-generation androgen receptor antagonists for the treatment of metastatic hormone-sensitive prostate cancer. (PubMed, Front Public Health) - "Compared to apalutamide, the ICER for enzalutamide was ¥643,309/QALY, while for darolutamide, the ICER was -¥40,625/QALY. For Chinese mHSPC patients, darolutamide is the most cost-effective treatment at a WTP threshold of ¥287,391/QALY, followed by apalutamide, with enzalutamide being less favorable."

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

Association between medication burden and acute care use in older metastatic prostate cancer patients on androgen receptor signaling inhibitors. (PubMed, Cancer) - "Medication burden, as characterized by suboptimal adherence and polypharmacy, is an independent risk factor for acute care use among older adults initiating ARSI treatment for metastatic prostate cancer. These findings highlight an opportunity for potential interventions to reduce downstream acute care use."

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

Targeting SSTR1 to overcome resistance to androgen receptor signaling inhibition in prostate cancer (PCF 2025) - "Background : Resistance to androgen receptor signaling inhibitors (ARSIs), such as abiraterone or enzalutamide, is a major obstacle to improving outcomes for patients with prostate cancer...Moreover, both SSTR1 agonists (CH275 and pasireotide) synergized with ARSIs (enzalutamide and apalutamide) in suppressing live cancer cells... ARSI treatment in CRPC models decreased SSTR1 expression. Activation of SSTR1 via agonists, in combination with ARSIs, exhibited enhanced efficacy in suppressing prostate cancer cells. These findings motivate the testing of SSTR1 agonists in vivo as a potential therapeutic approach and understanding the mechanisms of the synergistic effect of combination therapy to improve treatment response and outcomes for patients with prostate cancer."

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

Elucidating Drivers of Neuroendocrine Plasticity in Mouse Models of Prostate Cancer (PCF 2025) - "served on the Board of Directors of Novartis (2013-2025), is a cofounder of ORIC Pharmaceuticals and is a co-inventor of the prostate cancer drugs enzalutamide and apalutamide, covered by US patents 7,709,517; 8,183,274; 9,126,941; 8,445,507; 8,802,689; and 9,388,159 filed by the University of California. is on the scientific advisory board of Insitro. The other authors declare no competing interests."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ASCL1 • RB1

Uncovering Compensatory Innate Immune Checkpoints to Target Aggressive Variant Prostate Cancer (PCF 2025) - "They were then treated with a combination of degarelix and apalutamide (as ARPI). Funding Acknowledgements This work was supported by the Prostate Cancer Foundation 2022 Young Investigator Award (22YOUN10), and the UCSF Prostate Cancer Program 2022 Pilot Research Award. Conflicts of Interest Disclosure Statement The authors have no conflicts of interest to disclose."

IO biomarker • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • APOE • CD47 • PTEN • RB1 • SIRPA • TP53 • TREM2

ABI1 as liquid biopsy biomarker of ARPI resistance (PCF 2025) - " ABI1 Exon 4 was consistently enriched in tumors treated with enzalutamide, a finding recapitulated in vitro following enzalutamide and apalutamide exposure. Among 125 PDXs/PDOs derived from patients receiving neoadjuvant therapy (goserelin plus enzalutamide), ABI1 Exon 4 expression was significantly elevated in AR-independent phenotypes, including treatment-induced NEPC, double-negative PCa, and AMPC... ABI1 Exon 4 functions as a critical driver of transcriptional reprogramming and AR-independent resistance in prostate cancer. Its detection in saliva and blood establishes the foundation for a liquid biopsy assay with the potential to revolutionize monitoring of treatment resistance and guide precision therapy. Conflicts of Interest Disclosure Statement."

Biomarker • Biopsy • Liquid biopsy • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Prostate Cancer • Solid Tumor • FUS • KLK3 • NEAT1 • SRRM4

Development and external validation of a computational approach for early read out of randomized clinical trials in metastatic prostate cancer (PCF 2025) - "A computational simulation approach to predict the OS outcome of phase 3 mPC trials based on PSA kinetics from the first 4 months on trial was developed. This model, trained on 3 completed phase 3 trials, correctly predicted OS outcomes in 4 completed validation phase 3 trials with positive and negative outcomes for OS in both hormone sensitive and resistant mPC, and involving AR signaling inhibitors, chemotherapy and a PARP inhibitor. This model is being further validated with additional completed phase 3 trials, and once prospectively validated, has the potential to significantly shorten the follow up required for OS readout from phase 3 trials in mPC."

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

A phase II study combining ADT, novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide for patients with newly diagnosed, metastatic prostate cancer (ESMO 2025) - P2 | "Eligible participants will receive ADT in combination with one of the following nARIs (enzalutamide, apalutamide, darolutamide, rezvilutamide), initiated within three months of ADT commencement. Legal entity responsible for the study Sun Yat-sen University Cancer Center. Funding Jiangsu Hengrui Pharmaceuticals Co., Ltd."

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

Comparative hospitalization risk for cardiovascular outcomes associated with androgen receptor signalling inhibitors in prostate cancer: A nationwide cohort study (ESMO 2025) - P | "Prostate cancer patients who received their first prescription of ARSI among abiraterone acetate (AA), apalutamide (APA), or enzalutamide (ENZ) were included between 2018 and 2022 and followed until the occurrence of study outcomes, the study endpoint date, death, or treatment discontinuation. Conclusions APA and ENZ appear to exhibit a lower cardiotoxicity profile compared to AA. APA may offer further protection, particularly for hearth failure, supporting its use by physicians."

Clinical • 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) - P2 | "Methods Patients were required to have CRPC that was progressing through up to 2 previous ARSI therapies and were excluded for prior docetaxel treatment. The lead-in did not raise any safety concerns that now allows the trial to proceed. The combination is exhibiting preliminary clinical activity with both delayed radiographic progression and PSA response that merit further study and justify proceeding with full accrual."

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ENG • TGFB1

ProstACT Global: A phase 3 study of lutetium (Lu177) rosopatamab tetraxetan plus standard of care vs standard of care alone in patients with metastatic castration-resistant prostate cancer (ESMO 2025) - P3 | "In Part 1, patients are divided into 3 groups (n=10 each) to receive 2 single intravenous injections of 76 mCi each, 14d apart, of 177 Lu-rosopatamab with standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to characterize biodistribution & safety profiles of 177 Lu-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing mCRPC and have experienced disease progression on a minimum 12w prior therapy on their 1 st ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in metastatic castration-sensitive PC, non-metastatic CRPC, or mCRPC settings...Legal entity responsible for the study Telix Pharmaceuticals. Funding Telix Pharmaceuticals."

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

First interim efficacy analysis of the phase I/II PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC) (ESMO 2025) - P1/2 | "Methods Pts, allocated by investigator choice, received saruparib 60 mg once daily (OD) + enzalutamide 160 mg OD (Arm 1), abiraterone 1000 mg OD + 5 mg prednisone OD or twice daily (BD; Arm 2), or darolutamide 600 mg BD (Arm 3) until disease progression or intolerable adverse event (AE)...Arm 4 (+ apalutamide 240 mg OD) is ongoing dose escalation and was not included in this analysis...EvoPAR-01 is an ongoing phase 3 study evaluating this combination in mCSPC. Table: 2384MO mCRPC Prior ARPI N=19 mCRPC ARPI-naïve N=31 mCSPC N=27 Median duration of saruparib / ARPI exposure, months (range) 5.5 (1.2–17.7) / 5.5 (1.1–17.7) 14.7 (0.3–24.8) / 15.7 (0.4–24.8) 17.8 (0.2–28.2) / 19.7 (0.2–28.2) Any AE, n (%) 18 (94.7) 31 (100) 26 (96.3) Any AE causally related to saruparib, n (%) 16 (84.2) 28 (90.3) 23 (85.2) Any AE Gr ≥3, n (%) 6 (31.6) 16 (51.6) 14 (51.9) Any serious AE, n (%) 4 (21.1) 10 (32.3) 4 (14.8) Saruparib / ARPI discontinuation due to AE, n (%) 1 (5.3) / 1..."

Clinical • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • HRD

Validation of a large language model as a decision tool for drug interaction in prostate cancer: a comparative study against UpToDate. Meet-URO 5/25: GENIE study (ESMO 2025) - "Methods A total of 552 ARSI–drug pairs were generated via Cartesian product of four ARSIs (Enzalutamide, Apalutamide, Darolutamide, Abiraterone) and 138 common drugs for elderly cancer patients. Legal entity responsible for the study The authors. Funding Has not received any funding."

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

PRC2 inhibition enhances AR inhibitor response to delay treatment relapse in castration-sensitive prostate cancer by restricting adaptation of tumor cells in preclinical studies (AACR-NCI-EORTC 2025) - P1 | "In vivo xenografts were dosed with ORIC-944 or EZH2 inhibitor mevrometostat, darolutamide, or the combinations...Transcriptional effects induced by combining ORIC-944 and ARI were comparable irrespective of ARI (i.e. darolutamide, apalutamide or enzalutamide)... These preclinical results position ORIC-944 as a potential best-in-class PRC2 inhibitor that induces luminal cell fate and restricts lineage TF accessibility in both CRPC and CSPC settings, thereby extending the duration of response to ARI treatment by disabling cellular plasticity and delaying prostate tumor adaptation. ORIC-944 is under clinical evaluation in combination with ARIs in a global Phase 1b study (NCT05413421)."

Preclinical • Tumor cell • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • FOXA1 • HNF1A • ONECUT2

Adverse events of androgen receptor pathway inhibitors in prostate cancer from real world data. (PubMed, PLoS One) - "Our study provides important insight that we analyzed RWD and evaluated comparative drug safety across all type of prostate cancer. Although we could not make a conclusion whether which is the safest ARPI, we can suggest that each ARPIs have different types of AEs hence we can use this information during choosing ARPIs for prostate cancer patients."

Adverse events • Journal • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ATP6AP2

Comparative effectiveness of direct androgen receptor inhibitors (ARIs) versus abiraterone (Androgen Synthesis Inhibitor) in real-world patients (pts) in the US with metastatic hormone-sensitive prostate cancer (mHSPC) (ESMO 2025) - "Background ARIs (eg, apalutamide [Apa], enzalutamide [Enza]) and abiraterone (Abi, androgen synthesis inhibitor) are the first-line treatment (Rx) for pts with mHSPC...Exclusion: Prior Rx with docetaxel...ZIO, YJ: equal contribution. Legal entity responsible for the study The authors."

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