Nubeqa (darolutamide) / Bayer, Orion Corp - LARVOL DELTA

Neoadjuvant darolutamide and relugolix combination preceding radical prostatectomy for high risk localized and locally advanced prostate cancer: A phase I/Ib trial. (ASCO-GU 2025) - P1 | "Blood, tumor and urine are stored for future correlative studies. The trial was activated in October 2024."

Clinical • Metastases • P1 data • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Prognostic significance of PSA>0.2 after 6-12 months treatment for metastatic hormone-sensitive prostate cancer (mHSPC) intensified by androgen-receptor pathway inhibitors (ARPI): A multinational real-world analysis of the IRONMAN registry. (ASCO 2025) - "Intensification agents were: abiraterone acetate (576, 44.7%), apalutamide (283, 22.0%), darolutamide (135, 10.5%), or enzalutamide (294, 22.8%), and 122 (8.7%) received docetaxel in addition to ADT-ARPI. IRONMAN provides large real-world data validating the poor prognosis of mHSPC with PSA>0.2 after 6-12 months ADT-ARPI treatment and these patients could be targeted for intensification in future trials. Conversely, PSA<0.02 at 6-12 months defines the best prognosis and may be of interest for de-intensification strategies. OS and PFS outcomes by 12-month PSA strata."

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

3-weekly docetaxel 75 mg/m2 vs 2-weekly docetaxel 50 mg/m2 in combination with darolutamide + ADT in patients with mHSPC: Results from the randomised phase III ARASAFE trial (ESMO 2025) - P3 | "Table: LBA92 Docetaxel 75 mg/m 2 Q3W, N=129 Docetaxel 50 mg/m 2 Q2W, N=121 Age, median (IQR), years 68.0 (63.0, 74.0) 67.0 (63.0, 73.0) Metastases at primary diagnosis, n (%) 102 (79.7) 108 (89.3) Metastasis pattern at study entry, n (%) - Non-regional lymph node only 1 (0.8) 0 (0.0) - Bone / non-visceral 108 (83.7) 107 (88.4) - Visceral / other 20 (15.5) 14 (11.6) High volume disease, n (%) 108 (83.7) 104 (86.0) Alkaline phosphatase ≥ ULN, n (%) 73 (56.6) 73 (60.3) Serum PSA, median (IQR), ng/ml 12.2 (2.2, 75) 14.7 (3.6, 57.7) Conclusions ARASAFE demonstrates a statistically highly significant and clinically meaningful reduction in the incidence of grade 3-5 AE rate and NAER for the D50 approach, which may be considered a potential new standard of care. Further follow-up is ongoing to determine its efficacy in terms of oncological outcomes."

Clinical • Combination therapy • Late-breaking abstract • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer

Use of concomitant G-CSF in maintaining efficacious dose and safe delivery of docetaxel in combination with darolutamide in ARASENS: A phase III study. (PubMed, Eur J Cancer) - P3 | "Appropriate docetaxel dose modifications and early G-CSF use allowed almost all patients to receive an efficacious dose of docetaxel in combination with darolutamide and ADT and may prevent neutropenic complications in patients receiving docetaxel."

Journal • P3 data • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Hormone Sensitive Prostate Cancer • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

The National Pharmaceutical Pricing Authority (NPPA) has asked the manufacturers and marketers of the 17 life-saving drugs, which have been exempted from customs duty in the Union Budget 2026-27, to revise the maximum retail price (MRP) accordingly and inform the Authority. (Pharmabiz) - "The list of drugs include...darolutamide, toripalimab, serplulimab, tislelizumab, inotuzumab ozogamicin..."

Commercial • B Acute Lymphoblastic Leukemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Hormone Sensitive Prostate Cancer • Nasopharyngeal Carcinoma • Small Cell Lung Cancer

Efficacy and safety of darolutamide combined with trans-arterial chemoperfusion by docetaxel in metastatic hormone-sensitive prostate cancer (EAU 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Latin American Cooperative Oncology Group | Trial completion date: Jun 2025 ➔ Jun 2026

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

Disease progression patterns and association of prostate-specific antigen level with risk of progression in nonmetastatic castration-resistant prostate cancer. (PubMed, Prostate Cancer Prostatic Dis) - "Darolutamide plus ADT reduced the risk of metastatic progression and improved overall survival versus placebo plus ADT without changing patterns of disease progression through Month 24. Metastasis occurred without PSA progression in approximately 30% of metastatic events overall. Undetectable PSA with darolutamide was associated with reduced radiological progression that was maintained over time. These results highlight the importance of both imaging and PSA monitoring to identify disease progression in patients with nmCRPC."

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

Darolutamide efficacy, quality of life, and safety outcomes by age subgroup: ARANOTE post hoc analyses (ESMO 2025) - P3 | "Table: 2459P ARANOTE efficacy and quality of life outcomes by age Time to event Median, mo HR (95% CI) Darolutamide Placebo rPFS Overall NE 25.0 0.54 (0.41–0.71) <65 y NE 14.2 0.44 (0.27–0.71) 65–74 y NE NE 0.64 (0.42–0.98) ≥75 y NE 25.1 0.51 (0.31–0.84) TTD in FACT-P total score Overall 16.6 11.6 0.76 (0.61–0.94) <65 y 16.8 11.2 0.70 (0.47–1.05) 65–74 y 17.1 12.0 0.76 (0.55–1.05) ≥75 y 16.3 12.1 0.81 (0.55–1.19) mCRPC Overall NE 13.8 0.40 (0.32–0.51) <65 y NE 11.1 0.37 (0.24–0.55) 65–74 y NE 16.8 0.43 (0.30–0.61) ≥75 y NE 16.9 0.40 (0.25–0.64) PSA progression Overall NE 16.8 0.31 (0.23–0.41) <65 y NE 12.9 0.28 (0.17–0.46) 65–74 y NE 16.8 0.31 (0.20–0.48) ≥75 y NE 20.1 0.33 (0.19–0.58) NE, not estimable. Conclusions In all age groups, DARO consistently showed high efficacy, positive impact on HRQoL, and minimal burden of TEAEs."

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

Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS. (PubMed, Cancer Med) - P3 | "Darolutamide versus placebo improved MFS, OS, time to PSA progression, and HRQoL DetFS independent of prior local therapy, consistent with the overall ARAMIS population."

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

Orion Group Financial Statement Release January–December 2025 (Orion Press Release) - "'Underlying business developed very favourably and in addition the growth both in net sales and especially in operating profit was boosted by the EUR 180 million Nubeqa milestone. Excluding all milestones, our net sales increased by 18.5 percent to EUR 514.0 (433.9) million, and operating profit by 59.2 percent to EUR 146.8 (92.3) million...The Innovative Medicines business division more than doubled its net sales in Q4 thanks to the EUR 180 milestone and Nubeqa sales. Nubeqa has consistently exceeded expectations, and now we estimate that Orion's annual Nubeqa net sales have the potential to exceed EUR 1 billion by the end of the current decade.'"

Sales • Hormone Sensitive Prostate Cancer • Prostate Cancer

COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer (clinicaltrials.gov) - P4 | N=144 | Active, not recruiting | Sponsor: Brazilian Clinical Research Institute | Recruiting ➔ Active, not recruiting

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

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

Local Therapy and Outcome in De Novo Metastatic Prostate Cancer: Individual Patient Data Analysis of the TITAN and ARASENS Trials (ASTRO 2025) - "Materials/ In the ARASENS trial, patients with mPCa were randomly assigned to ADT plus docetaxel versus ADT plus docetaxel plus darolutamide. in the TITAN trial, patients were randomly assigned to ADT (+/-docetaxel) versus ADT plus apalutamide... In this IPD analysis of two trials, exposure to local therapy in de novo mPCa was associated with evidence of superior OS in patients treated with either ADT or ADT plus ARPI, respectively. The findings emphasize the role of prostate directed local therapy even in ARPI treated men with de novo mPCa."

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

Syndrome of Inappropriate Antidiuretic Hormone Secretion and Thrombotic Microangiopathy as Paraneoplastic Syndromes Complicating BRCA2-Mutated Metastatic Prostate Cancer. (PubMed, Cureus) - "He was treated with free water restriction, hypertonic saline, and triplet systemic therapy (docetaxel, androgen deprivation, and darolutamide) and discharged in stable condition. Management of these complications requires addressing the underlying cancer with definitive treatment. The case highlights the vigilance for atypical paraneoplastic manifestations, the need for early genomic testing, and the exploration of novel therapeutic strategies in BRCA2-driven prostate cancer."

Journal • Cardiovascular • Genito-urinary Cancer • Heart Failure • Hematological Disorders • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • BRCA2

Treatment patterns in patients with castration-resistant prostate cancer who received darolutamide in the ARAMIS trial in Spain: PARASEC study. (PubMed, Clin Transl Oncol) - "These real-world practice patterns suggest a lack of consensus in Spanish clinical practice for the management of patients with mCRPC, indicating that there is a need for more standardized strategies and unification of the criteria to make decisions in accordance with the recommendations of international clinical practice guidelines."

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

ASCERTAIN: An open-label, randomized, phase 1, window-of-opportunity study to investigate the biological effects of AZD5305 and darolutamide alone or in combination in men with prostate cancer eligible for radical prostatectomy. (ASCO-GU 2024) - P1 | "The Phase 3 PROpel study showed that first-line combination treatment with olaparib and abiraterone significantly improved radiographic progression-free survival (rPFS) over abiraterone alone in pts with metastatic castration-resistant PC (mCRPC) (hazard ratio [HR], 0.66; 95% CI, 0.54 to 0.81; p<0.001). Similarly, the Phase 3 TALAPRO-2 study showed that first-line talazoparib with enzalutamide resulted in statistically significant improvement in rPFS over enzalutamide alone in pts with mCRPC (HR, 0.63; 95% CI, 0.51 to 0.78; p<0.0001)...Enrollment began in September 2023; sites across North America, Europe and Australia will enroll up to 120 patients. Clinical trial information: NCT05938270."

Clinical • P1 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • PARP2

Addition of darolutamide to first line treatment of metastatic castration-resistant prostate cancer (mCRPC): A randomized open label phase II trial (SAKK 08/23). (ASCO-GU 2025) - P2 | "Funded by State secretariat for education, research and information (SERI) Switzerland Clinical Trial Registration Number: NCT06401980 Background: The implementation of androgen-receptor pathway inhibitors (ARPI) +/- docetaxel (doce) in addition to androgen deprivation therapy (ADT) in metastatic hormone sensitive prostate cancer (mHSPC) has limited the therapeutic options in the mCRPC setting...Continuing enzalutamide in addition to doce versus a switch to doce alone after progression on enzalutamide in later line mCRPC has been demonstrated to prolong PFS in a phase 3 trial...Patients will be randomized 1:1 to receive physician's choice standard of care (SOC: doce, cabazitaxel, 177lutetium-PSMA, radium-223 or olaparib) or SOC with daro...The trial will enroll pts in Switzerland and Spain. Accrual to the study is currently ongoing."

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

BRCAAway: A randomized phase 2 trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) bearing homologous recombination-repair mutations (HRRm). (ASCO-GU 2024) - P2 | "Median age: 67 years (range 42-85); 55 White, 6 Black; prior Docetaxel 26% for mHSPC, Darolutamide/Enzalutamide 3.3% for nmCRPC; disease sites: bone n=44, viscera n=12, lymph node n=31, other n=3; median baseline PSA: 14 ng/ml (range 0.15-4,037 ng/ml). In mCRPC pts with BRCA1/2 or ATM alterations, abiraterone/prednisone + olaparib was well tolerated and resulted in a longer PFS vs either agent alone or sequentially. Clinical trial information: NCT03012321."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • ATM • BRCA1 • BRCA2 • HRD

23146: How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany (clinicaltrials.gov) - P=N/A | N=500 | Not yet recruiting | Sponsor: Bayer

HEOR • New trial • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase 3 ARANOTE trial (DKK 2026) - No abstract available

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

3-Weekly Docetaxel 75 mg/m2 vs 2-Weekly Docetaxel 50 mg/m2 in Combination with Darolutamide + ADT in Patients with mHSPC – Results from the Randomised Phase 3 ARASAFE Trial (DKK 2026) - No abstract available

Clinical • Combination therapy • Late-breaking abstract • P3 data • Hormone Sensitive Prostate Cancer • Prostate Cancer

Ultra-low PSA Response (<0.02 ng/mL) With Darolutamide Plus ADT in ARANOTE Correlates With Greatly Improved Clinical Outcomes (DKK 2026) - No abstract available

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

Age-related efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC): a subgroup analysis of ARASENS (DKK 2026) - No abstract available

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

Ontario fast-tracking public coverage for six new cancer drugs (CTV News) - "Through the Funding Accelerated for Specific Treatments (FAST) program – a three-year pilot program – Ontarians will get coverage to new drugs for lung, prostate, liver and colorectal cancers, as well as leukemia and lymphoma....The new drugs include Tagrisso, Scemblix, Nubeqa, Calquence, and Opdivo with Yervoy. They became available to Ontario patients through the FAST program in October 2025."

dMMR • MSI-H • Reimbursement • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Hepatocellular Cancer • Hormone Sensitive Prostate Cancer • Mantle Cell Lymphoma • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Urothelial Cancer