Darolutamide

Post hoc analyses from the pivotal Phase III ARANOTE trial evaluating health-related quality of life (HRQoL) outcomes with NUBEQA ® (darolutamide) plus androgen deprivation therapy (ADT) will be presented Additional data include an analysis of the investigational Phase III PEACE III study of the first and only approved targeted alpha emitting radiopharmaceutical, XOFIGO ® (radium-223 dichloride), that treats bone metastases in metastatic castration-resistant prostate cancer (mCRPC) Safety and efficacy results for the investigational compound sevabertinib (BAY 2927088) in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) will also be showcased Bayer will also present data from the Phase III OASIS-4 trial conducted outside of the U.S. of the investigational compound elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) caused by adjuvant endocrine therapy WHIPPANY, N.J.--(BUSINESS WIRE)--The latest data from studies across Bayer’s oncology and women’s health portfolios will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from May 30–June 3. These data underscore Bayer’s commitment to advancing treatments across different stages of cancer and driving the development of healthcare treatments, including for prostate and lung cancer. This year’s ASCO presence also underscores Bayer’s long-standing commitment to addressing diverse needs in women’s health. The company will present post hoc analyses on health-related quality of life (HRQoL) outcomes with NUBEQA® (darolutamide) from the pivotal Phase III ARANOTE trial. Additional information will be presented from the investigational Phase III ARASTEP trial evaluating NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT in patients with prostate cancer with high-risk biochemical recurrence (BCR). 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 Presentations will also highlight post hoc analyses from the European Organization for Research and Treatment of Cancer’s (EORTC) Phase III PEACE III study evaluating the impact of the addition of six cycles of XOFIGO® (radium-223 dichloride), in combination with enzalutamide, on the time to prostate-specific antigen (PSA) and alkaline phosphatase (ALP) decline. Additionally, initial results from the Phase II COMRADE study investigating the use of XOFIGO and olaparib in men with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases will be presented as an oral presentation. Investigator-initiated research will be presented on XOFIGO long-term safety outcomes in mCRPC from the Phase IV REASSURE study. 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 In HER2-mutant non-small cell lung cancer (NSCLC), Bayer is presenting data from the ongoing SOHO-01 study, which is evaluating the safety and efficacy of sevabertinib (BAY 2927088) in patients with advanced HER2-mutant NSCLC who have been pretreated but naïve to HER2-targeted therapy or have not received any treatment for advanced disease. Sevabertinib is an investigational oral, small molecule tyrosine kinase inhibitor (TKI) being evaluated as a potential new targeted therapy for patients with NSCLC harboring HER2-activating mutations. Two sets of detailed data from the Phase III OASIS-4 trial of the investigational compound elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) in women undergoing adjuvant endocrine therapy for the treatment or prevention of hormone receptor-positive (HR+) breast cancer will be presented. Details on selected abstracts from Bayer at the 2025 ASCO Annual Meeting follow: NUBEQA (darolutamide) Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial Abstract: 5004; June 3, 9:45 a.m.–12:45 p.m. CDT Abstract: 5004; June 3, 9:45 a.m.–12:45 p.m. CDT 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) Abstract: TPS5131; June 2, 9:00 a.m.–12:00 p.m. CDT Abstract: TPS5131; June 2, 9:00 a.m.–12:00 p.m. CDT XOFIGO (radium-223 dichloride) Long-term safety of radium-223 (Ra-223) in metastatic castration-resistant prostate cancer (mCRPC): 7-year follow-up from the largest global prospective study Abstract: 5048; June 2, 9:00 a.m.–12:00 p.m. CDT Abstract: 5048; June 2, 9:00 a.m.–12:00 p.m. CDT Time to PSA and alkaline phosphatase decline in the EORTC-1333 PEACE III study evaluating the addition of 6 cycles of RA223 in castration-resistant prostate cancer starting enzalutamide Abstract: 5062; June 2, 9:00 a.m.–12:00 p.m. CDT Abstract: 5062; June 2, 9:00 a.m.–12:00 p.m. CDT A multicenter, randomized, phase 2, investigator-initiated ETCTN trial of olaparib + radium-223 vs. radium-223 in men with castration-resistant prostate cancer (CRPC) with bone metastases (BM) (COMRADE): Initial efficacy and biomarker analysis Abstract: 5007; June 3, 9:45 a.m.–12:45 p.m. CDT Abstract: 5007; June 3, 9:45 a.m.–12:45 p.m. CDT Sevabertinib (BAY 2927088) SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease Abstract: 8504; June 1, 8:00 a.m.–11:00 a.m. CDT Abstract: 8504; June 1, 8:00 a.m.–11:00 a.m. CDT Elinzanetant Efficacy and safety of elinzanetant for vasomotor symptoms associated with adjuvant endocrine therapy: Phase 3 OASIS 4 trial Abstract: 508; June 2, 3:00 p.m.–6:00 p.m. CDT Abstract: 508; June 2, 3:00 p.m.–6:00 p.m. CDT Impact of elinzanetant on sleep disturbances and quality of life in women undergoing adjuvant endocrine therapy for breast cancer: Phase 3 OASIS 4 trial Abstract: 12063; June 2, 1:30 p.m.–4:30 p.m. CDT Abstract: 12063; June 2, 1:30 p.m.–4:30 p.m. CDT 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.3 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.4,5 About XOFIGO (radium-223 dichloride) Injection2 Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. IMPORTANT SAFETY INFORMATION Warnings and Precautions: Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure. Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care. Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued. Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established. Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo. Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations. Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia. Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo. Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial. Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy. Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%). Please see the full Prescribing Information for Xofigo (radium-223 dichloride). About Sevabertinib (BAY 2927088)6 Sevabertinib is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with non-small cell lung cancer (NSCLC) harboring human epidermal growth factor receptor 2 (HER2)-activating mutations. Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations. Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with selectivity for mutant versus wild-type EGFR. Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, Mass., USA. About Elinzanetant Elinzanetant is a dual NK-1 and NK-3 receptor antagonist, in late-stage clinical development for the treatment of moderate to severe VMS due to menopause. Increasing evidence indicates that hypothalamic kisspeptin/neurokinin/dynorphin (KNDy) neurons play a role in thermoregulation. KNDy neurons express receptor/ligand systems, including NK-1 and NK-3 receptors and their respective ligands, substance P and neurokinin B (NKB). Declining estrogenic activity resulting from menopause leads to hypertrophy and hyperactivity of KNDy neurons. This is accompanied by elevated gene expression of NKB and substance P disrupting thermoregulation and resulting in subsequent VMS. Elinzanetant is an investigational agent and has not been approved by any health authority in any country. 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 Women’s Healthcare at Bayer Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations. 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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com. ©2025 Bayer BAYER, the Bayer Cross, NUBEQA and XOFIGO are registered trademarks of Bayer. Find more information at https://pharma.bayer.com/ Our online press service is just a click away: www.bayer.us/en/newsroom Follow us on Facebook: http://www.facebook.com/bayer Follow us on X: https://X.com/BayerUS 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 NUBEQA ® (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023. XOFIGO ® (radium Ra 223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2024. Hyuna S, et al. Ca Cancer J Clin . 2021;71:209-249. Prostate Cancer: Statistic. Cancer.Net. https://www.cancer.net/cancer-types/prostate-cancer/statistics . Accessed May 5, 2025. American Cancer Society. Cancer Facts & Figures 2024. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts-figures.html . Accessed May 5, 2025. First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/​or Human Epidermal Growth Factor Receptor 2 (HER2). Clinical trial registration No. NCT05099172. https://clinicaltrials.gov/study/NCT05099172 . Accessed April 21, 2025.