Bayer expands global clinical program for nubeqa® (darolutamide) in prostate cancer
Whippany, n.j.--(business wire)--bayer further expands the global clinical development program for nubeqa® (darolutamide) in prostate cancer. the new phase iii clinical study, arastep, will investigate the efficacy of nubeqa plus androgen deprivation therapy (adt) versus adt alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (bcr) who have no evidence of metastatic disease by conventional imaging and a positive psma pet/ct at baseline. bcr is defined as rising prostate-specific antigen (psa) levels with a doubling time of 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, decreased appetite, rash, 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 hormone-sensitive prostate cancer and biochemical recurrence (bcr) prostate cancer is the second most commonly diagnosed malignancy in men worldwide. in 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.4 rates of advanced prostate cancer diagnoses have risen 4.5% annually since 2011.5 hormone-sensitive prostate cancer is a type of prostate cancer that needs androgens (male hormones) to grow and therefore stops growing when androgens are not present. almost all early-stage prostate cancers are androgen-dependent.6 up to 50% of patients with prostate cancer develop elevated prostate-specific antigen (psa) levels in their blood after primary therapy (surgery and/or radiation therapy).7 this disease state is called biochemical recurrence (bcr). current treatment options for patients with biochemical recurrent prostate cancer include prostatectomy, intending to be curative. if these treatments are unsuccessful, androgen deprivation therapy (adt) is an option to control disease.2 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. its 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 2022, the group employed around 101,000 people and had sales of 50.7 billion euros. r&d expenses before special items amounted to 6.2 billion euros. for more information, go to www.bayer.com. © 2023 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 pp-nub-us-2289-1
