Bayer to Unveil Latest NUBEQA® (darolutamide) Data and Prostate Cancer Research at American Urological Association (AUA) 2025 Annual Meeting

• Bayer will present new data from the ARANOTE trial evaluating ultra-low prostate-specific antigen responses with NUBEQA^® (darolutamide) plus androgen deprivation therapy (ADT)
• Efficacy and safety results from an additional ARANOTE trial subgroup analysis in Black patients will be presented
• The company will present data on the long-term safety and tolerability of extended treatment with NUBEQA from the ARASENS Rollover trial and a North American subgroup analysis of the Darolutamide Observational (DAROL) trial
• Results from a U.S.-based quantitative survey on the challenges and unmet needs of caregivers of men with prostate cancer also will be presented

ABSTRACTS: IP26-07, MP16-01, IP26-06, IP26-25, IP04-31

Bayer will present new data for NUBEQA^® (darolutamide) in prostate cancer at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025. These data support the potential of NUBEQA as a treatment option across the prostate cancer disease spectrum and in diverse patient populations.

NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).¹

The company will present post-hoc analyses of ultra-low prostate-specific antigen (PSA) responses (<0.02 ng/mL) and the correlation of ultra-low PSA responses with clinical outcomes from the Phase III ARANOTE trial evaluating NUBEQA and androgen deprivation therapy (ADT) in mHSPC.

An additional ARANOTE analysis on the efficacy and safety of NUBEQA plus ADT in Black men with mHSPC will be presented.

Additionally, data from the Phase III ARASENS Rollover trial evaluating the long-term safety and tolerability benefit of extended treatment with NUBEQA will be presented.

Other key data to be presented include the North American subgroup analysis from the third interim analysis of the Darolutamide Observational (DAROL) trial evaluating the safety and efficacy of NUBEQA in a real-world setting in patients with nmCRPC, and an update on the in progress Phase III ARASTEP trial, evaluating NUBEQA plus ADT in patients with high-risk biochemical recurrence.

A separate presentation will highlight results from a U.S.-based quantitative survey on the challenges and unmet needs of caregivers of men with prostate cancer.

Details on selected abstracts from Bayer at the AUA 2025 Annual Meeting follow:

NUBEQA (darolutamide):

• Ultra-low PSA Response (<0.02 ng/mL) with Darolutamide Plus ADT in ARANOTE Correlates with Greatly Improved Clinical Outcomes
  • Interactive Poster Session: IP26-07; April 29, 9:30-11:30 a.m. PDT
• Efficacy and Safety of Darolutamide Plus Androgen-Deprivation Therapy (ADT) in Black Patients with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) from the Phase 3 ARANOTE Trial
  • Moderated Poster: MP16-01; April 27, 1:00-3:00 p.m. PDT
• Long-Term Safety and Tolerability of Extended Treatment with Darolutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Insights from ARASENS Rollover Study
  • Interactive Poster: IP26-06; April 29, 9:30-11:30 a.m. PDT
• Prespecified Third Interim Analysis of the Darolutamide Observational (DAROL) Study in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): North American (NAm) Subgroup Analysis
  • Interactive Poster: IP26-25; April 29, 9:30-11:30 a.m. PDT
• 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)
  • Clinical Trials in Progress Presentation: April 28, 2:44- 2:52 p.m. PDT

Prostate Cancer:

• Challenges and Unmet Needs of Caregivers for Patients with Prostate Cancer: A US-based Quantitative Survey
  • Abstract IP04-31; April 26, 9:30-11:30 a.m. PDT

About NUBEQA^® (darolutamide)¹

NUBEQA^® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

IMPORTANT SAFETY INFORMATION

Warnings & Precautions

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.² In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide.^3,4

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed.^5,6,7 Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.⁸

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

^© 2025 Bayer

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

1. NUBEQA^® (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023.
2. Hyuna S et al. Ca Cancer J Clin. 2021;71:209-249.
3. Prostate Cancer: Statistic. Cancer.Net. https://www.cancer.net/cancer-types/prostate-cancer/statistics. September 2024.
4. American Cancer Society. Cancer Facts & Figures 2024. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts-figures.html. September 2024.
5. Piombino C et al. Cancers (Basel). 2023;15(20):4945.
6. Helgstrand JT et al. Cancer. 2018;124(14):2931-2938.
7. Buzzoni C et al. Eur. Urol. 2015;68:885-890.
8. Hahn AW et al. Am Soc Clin Oncol Educ Book. 2018 May 23;38:363-371.

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