- Bayer is committed to advancing treatment in prostate cancer care, showcasing new analyses from its comprehensive clinical trial program for NUBEQA® (darolutamide), which includes the ARANOTE, ARASENS, ARAMON, and ARASTEP trials
- The company also highlights data on XOFIGO® (radium-223 dichloride) in metastatic castration-resistant prostate cancer and biochemically recurrent prostate cancer
Reno, Nevada (UroToday.com) -- Bayer will present new data from its prostate cancer portfolio at the upcoming American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, taking place in San Francisco, California, from February 13-15, 2025. These presentations reinforce Bayer´s commitment to advancing treatments across different stages of prostate cancer.
Data will include a subgroup analysis from the investigational Phase III ARANOTE trial, evaluating the efficacy and safety of NUBEQA® (darolutamide) and androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume. Subgroup analyses from the investigational Phase III ARASENS trial will be presented, including evaluating age-related efficacy and safety of NUBEQA plus ADT and docetaxel in patients with mHSPC and an analysis of concomitant granulocyte colony-stimulating factor (G-CSF) use in maintaining an efficacious dose and safe delivery of docetaxel in combination with NUBEQA in patients with mHSPC.
Lead-in phase results will be presented from the investigational Phase II ARAMON trial, investigating NUBEQA monotherapy in patients with castration-sensitive prostate cancer (CSPC) after biochemical recurrence (BCR) and other data to be presented will focus on clinical use and outcomes of androgen-receptor pathway inhibitors triplet therapy for mHSPC. A trial-in-progress update will also be presented for the ongoing investigational Phase III ARASTEP trial investigating NUBEQA plus ADT in patients with high-risk BCR of prostate cancer.
NUBEQA is indicated in the U.S. for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1
In radiopharmaceuticals, investigator-initiated research will be presented on XOFIGO® (radium-223 dichloride) without ADT in patients with BCR and positron emission tomography (PET) findings in the bones. Investigator-initiated research will be presented evaluating the safety and efficacy of retreatment of metastatic castration-resistant prostate cancer (mCRPC) patients with XOFIGO therapy in daily practice. Data from three Real World Evidence studies, reviewing data from over 30 observational studies, will be presented.
XOFIGO is indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.2
Details on selected abstracts from Bayer at the 2025 ASCO GU Cancers Symposium are listed below:
NUBEQA (darolutamide)
- Darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume: Subgroup analysis of the phase 3 ARANOTE trial
- Abstract: 151; February 13. 11:25 AM – 12:45 PM PST
- 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
- Abstract: 143; February 13. 11:25 AM – 12:45 PM PST
- Concomitant G-CSF use in maintaining an efficacious dose and safe delivery of docetaxel in combination with darolutamide in patients with metastatic hormone sensitive prostate cancer (mHSPC): ARASENS, a phase 3 study
- Abstract: 152; February 13. 11:25 AM – 12:45 PM PST
- Darolutamide monotherapy in patients with castration-sensitive prostate cancer (CSPC) after biochemical recurrence (BCR): ARAMON lead-in phase results
- Abstract: 150; February 13. 11:25 AM – 12:45 PM PST
- Clinical use and outcomes of Androgen-Receptor pAthwAy inhibitors Triplet therapy for metastatic hormone-sensitive prostate cancer (ARAAT) – Real World Evidence (RWE)
- Abstract: 66; February 13. 11:25 AM – 12:45 PM PST
- Darolutamide plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP) - Trial in Progress (TiP)
- Abstract: TPS432; February 13. 11:25 AM – 12:45 PM PST
- Re-treatment of metastatic castration-resistant prostate cancer patients with radium-223 therapy in daily practice - Investigator-Initiated Research (IIR)
- Abstract: 183; February 13. 11:25 AM – 12:45 PM PST
- Radium 223 without Androgen Deprivation Therapy (ADT) in Patients (Pts) with Biochemically Recurrent Prostate Cancer (BCR) and PET Findings in the Bones - Investigator-Initiated Research (IIR)
- Abstract: 180; February 13. 11:25 AM -12:45 PM PST
- Effectiveness and safety of radium-223 in men with metastatic castration-resistant prostate cancer (mCRPC): A systematic literature review of 48 real-world studies – Real World Evidence (RWE)
- Abstract: 81; February 13. 11:25 AM – 12:45 PM PST
- Real-world treatment patterns and survival in men with metastatic castration-resistant prostate cancer (mCRPC) who previously progressed from metastatic hormone-sensitive prostate cancer (mHSPC) between 2020 to 2023 in the United States – Real World Evidence (RWE)
- Abstract: 99; February 13. 11:25 AM -12:45 PM PST
- Treatment patterns and survival in men with metastatic castration-resistant prostate cancer (mCRPC): A systematic literature review of 35 real-world observational studies – Real World Evidence (RWE)
- Abstract: 101; February 13. 11:25 AM -12:45 PM PST