New nubeqa® (darolutamide) subgroup analyses from the phase iii arasens trial in metastatic hormone-sensitive prostate cancer (mhspc) patients presented at asco gu
Whippany, n.j.--(business wire)--subgroup analyses from the pivotal phase iii arasens trial support overall survival (os) benefits of nubeqa® (darolutamide) plus androgen deprivation therapy (adt) and docetaxel compared to adt and docetaxel in patients with high-volume and high and low-risk metastatic hormone-sensitive prostate cancer (mhspc). low-volume disease was also assessed with results suggestive of a survival benefit.1 nubeqa is currently 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).2 the full results were presented as an oral presentation during the asco gu cancers symposium and simultaneously published in the journal of clinical oncology.1 these results build on existing data from the arasens trial, which show that nubeqa plus adt and docetaxel compared to adt and docetaxel significantly reduces the risk of death in patients with mhspc by 32% (hr=0.68; 95% ci 0.57-0.80; p2% 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 metastatic hormone-sensitive prostate cancer 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.5 rates of advanced prostate cancer diagnoses have risen 4.5% annually since 2011.6 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.7,8 upon relapse, when the disease will metastasize or spread, the disease is hormone-sensitive and androgen deprivation therapy (adt) is the cornerstone of treatment. current treatment options for men with metastatic hormone-sensitive prostate cancer (mhspc) include hormone therapy, such as adt, androgen receptor pathway inhibitors plus adt or a combination of docetaxel chemotherapy and adt. despite these treatments, a large proportion of men with mhspc will eventually experience progression to metastatic castration-resistant prostate cancer (mcrpc), a condition with high morbidity and limited survival.9,10 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 planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. bayer is committed to drive sustainable development and generate 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 2021, the group employed around 100,000 people and had sales of 44.1 billion euros. r&d expenses before special items amounted to 5.3 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-2190-1 2/23
