AUA 2026: Phase II ARASEC Data Further Supports the Efficacy and Safety of NUBEQA® (darolutamide) Plus ADT in Patients with Metastatic Castration-Sensitive Prostate Cancer

• Primary results from the Phase II ARASEC trial show that NUBEQA^® (darolutamide) plus androgen deprivation therapy (ADT) showed a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC) compared to a matched ADT-alone arm from a historical control in the CHAARTED trial
• ARASEC is a multicenter, open-label trial in U.S. patients designed to be complementary to the pivotal Phase III ARANOTE trial
• Results are being presented today as a plenary session during the American Urological Association (AUA) Annual Meeting

WHIPPANY, N.J.--(BUSINESS WIRE)--New data from the Phase II ARASEC trial show NUBEQA^® (darolutamide) plus androgen deprivation therapy (ADT) resulted in a 71% reduction in the risk of progression or death per CHAARTED criteria compared to ADT alone (HR 0.29; 95% CI 0.20–0.40; P<0.001) in U.S. patients (N=320) with metastatic castration-sensitive prostate cancer (mCSPC). NUBEQA plus ADT was also associated with significant improvements in overall survival (OS) (HR 0.50; 95% CI 0.30–0.82; P=0.003), time to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.26; 95% CI 0.18–0.38; P<0.001), and radiological progression-free survival (rPFS) (HR 0.30; 95% CI 0.19–0.48; P<0.001) vs a matched ADT alone arm from a historical control.¹

Some notable limitations of the study include: open-label Phase II study design, the absence of randomization, and the use of historical external control. Primary results are being presented today as a plenary session during the American Urological Association (AUA) Annual Meeting.

NUBEQA is indicated in the U.S. for the treatment of adult patients with mCSPC, both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).²

In the ARASEC trial, no new safety signals were observed in the NUBEQA plus ADT arm, consistent with previous studies. Safety results were reported descriptively for the NUBEQA plus ADT arm only, as safety data were not routinely collected in the CHAARTED ADT-alone arm. In the NUBEQA plus ADT matched population, 58% of treatment-emergent adverse events (TEAEs) were grade 1/2 and 8% discontinued NUBEQA due to TEAEs.

“Results from the Phase II ARASEC trial provide additional evidence regarding the efficacy and safety of darolutamide plus ADT in patients with mCSPC,” said Rana R. McKay, MD, Medical Oncologist and Professor of Medicine, Urology, and Radiation Medicine and Applied Sciences and Principal Investigator of the ARASEC trial. “The data further support NUBEQA’s ability to offer physicians and patients with prostate cancer a treatment option that is both effective and generally well tolerated.”

Prostate cancer is the leading cancer diagnosis among men in the U.S.³ Around 313,780 men are diagnosed with prostate cancer each year and about 35,770 die from the disease in the U.S.³ By 2040, prostate cancer diagnoses are projected to increase to 2.9 million worldwide.⁴ For men with mCSPC, just over a third (~38%) will survive five years or more after diagnosis,⁵ and most progress to castration-resistant prostate cancer (CRPC), a condition with limited long-term survival.^6,7

“The ARASEC trial was designed to further evaluate NUBEQA plus ADT in patients with metastatic castration-sensitive prostate cancer using a rigorous and innovative study approach,” said Yesmean Wahdan, Senior Vice President and Head of Medical Affairs, U.S. and North America Pharmaceuticals at Bayer. “Supported by our robust clinical development program, these results add to the growing body of evidence demonstrating the efficacy and tolerability of NUBEQA and reinforce our commitment to expanding treatment options for patients earlier in the disease.”

About the ARASEC trial⁸

ARASEC (NCT05059236), is a U.S. prospective open-label, multicenter, Phase II study with an external control arm, complementary to the ARANOTE trial. The study compares NUBEQA plus ADT with a historical external ADT-alone control arm. Patients with mCSPC on conventional imaging and no prior systemic therapy were prospectively enrolled to receive NUBEQA 600 mg twice daily plus ADT. Patients were matched 1:1 to patients enrolled on the ADT-alone arm of the Phase III CHAARTED study using propensity scores based on baseline prognostic characteristics (age, ECOG performance status, CHAARTED-defined extent of disease, prior local therapy, Gleason score, baseline prostate-specific antigen [PSA]). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), time to metastatic castration-resistant prostate cancer (mCRPC), radiological PFS (rPFS; based on imaging frequency as clinically indicated), PSA <0.2 ng/mL response rates, and safety (reported descriptively for the darolutamide plus ADT arm only, as safety data were not routinely collected in the CHAARTED ADT-alone arm).

Potential limitations of the study include: open-label Phase II study design, the absence of randomization, and the use of historical external control. Although propensity score matching was used, this method only adjusts for measured variables; unknown or unmeasured confounders may still remain. Use of a historical external control arm may introduce bias due to changes in standards of care over time, differences in endpoint definitions, and assessment methods.

About NUBEQA^® (darolutamide)²

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 was 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 castration-sensitive prostate cancer (mCSPC)
• Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel

IMPORTANT SAFETY INFORMATION

Warnings & Precautions

Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo.

In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 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 – Seizure occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA.

In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA.

It is unknown whether anti-epileptic 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 – The 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 and in 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 and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 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 (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%).

In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%).

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%).

Drug Interactions

Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug.

NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA.

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 Castration-Sensitive Prostate Cancer

Prostate cancer is the leading cancer diagnosis among men in the U.S.³ Around 313,780 men are diagnosed with prostate cancer each year and about 35,770 die from the disease in the U.S.³

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. mCSPC is an advanced form of prostate cancer, when the cancer has spread beyond the prostate to other organs but is still responding to hormone therapy that lowers testosterone, such as androgen deprivation therapy (ADT). Despite treatment, most men with mCSPC will eventually progress to castration-resistant prostate cancer, a condition with limited survival.^6,7

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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

© 2026 Bayer
BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

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 McKay R, et al. Darolutamide plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC): ARASEC – US prospective, open-label phase 2 study with an external control arm. The Journal of Urology. May 14, 2026. https://doi.org/10.1097/01.JU.0001192572.07890.f8. Presented at AUA 2026.
² NUBEQA® (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; June 2025.
³ National Cancer Institute. Cancer Stat Facts: Common Cancer Sites. https://seer.cancer.gov/statfacts/html/common.html. Accessed January 2026.
⁴ James ND, et al. Lancet 2024; 403: 1683–722.
⁵ National Cancer Institute. Cancer Stat Facts: Prostate Cancer. https://seer.cancer.gov/statfacts/html/prost.html. Accessed January 2026.
⁶ Siegel DA, et al. MMWR Morb Mortal Wkly Rep 2020; 69:1473–1480.
⁷ Hahn A, et al. Am Soc Clin Oncol Educ Book. 2018; 23;38:363–371.
⁸ ClinicalTrials.gov NCT05059236. A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study. (ARASEC). https://clinicaltrials.gov/study/NCT05059236. Accessed January 2026.

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