{"id":54022,"date":"2023-02-16T20:05:12","date_gmt":"2023-02-16T19:05:12","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/new-nubeqa-darolutamide-subgroup-analyses-from-the-phase-iii-arasens-trial-in-metastatic-hormone-sensitive-prostate-cancer-mhspc-patients-presented-at-asco-gu\/"},"modified":"2023-02-16T20:05:12","modified_gmt":"2023-02-16T19:05:12","slug":"new-nubeqa-darolutamide-subgroup-analyses-from-the-phase-iii-arasens-trial-in-metastatic-hormone-sensitive-prostate-cancer-mhspc-patients-presented-at-asco-gu","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/new-nubeqa-darolutamide-subgroup-analyses-from-the-phase-iii-arasens-trial-in-metastatic-hormone-sensitive-prostate-cancer-mhspc-patients-presented-at-asco-gu\/","title":{"rendered":"New NUBEQA\u00ae (darolutamide) Subgroup Analyses from the Phase III ARASENS Trial in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients Presented at ASCO GU"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nNew post hoc subgroup analyses from Phase III ARASENS trial in mHSPC show that NUBEQA plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel increased overall survival (OS) in specific subgroups with various types of metastatic disease burden and risk<sup>1<\/sup>\n<\/li>\n<li>\nIncidence of adverse events was similar between treatment groups across all high-volume and low-volume disease and high-risk and low-risk disease subgroups<sup>1<\/sup>\n<\/li>\n<li>\nThe results were presented in an oral presentation at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium and simultaneously published in the<i> Journal of Clinical Oncology<\/i><sup>1<\/sup>\n<\/li>\n<\/ul>\n<p>\n<b>Abstract: 15<\/b>\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230216005526\/en\/830078\/4\/Bayer_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230216005526\/en\/830078\/21\/Bayer_Logo.jpg\"><\/a><\/p>\n<p>WHIPPANY, N.J.&#8211;(BUSINESS WIRE)&#8211;Subgroup analyses from the pivotal Phase III ARASENS trial support overall survival (OS) benefits of NUBEQA<sup>\u00ae<\/sup> (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.<sup>1<\/sup> 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).<sup>2<\/sup> The full results were presented as an oral presentation during the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fconferences.asco.org%2Fgu%2Fattend%3Fcmpid%3Dcc_ascoorg_gu_register_psrh_googleadwords_brand_011322_021622___ta1%26gclid%3DEAIaIQobChMI2YL9gIe89QIVAYjICh1_5wvvEAAYASAAEgJ71_D_BwE&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=ASCO+GU+Cancers+Symposium&amp;index=1&amp;md5=e6d2a688f9941463d878056da4d4c542\" rel=\"nofollow noopener\" shape=\"rect\">ASCO GU Cancers Symposium<\/a> and simultaneously published in the <i>Journal of Clinical Oncology.<\/i><sup>1<\/sup>\n<\/p>\n<p>\nThese 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; P&lt;0.0001).<sup>3<\/sup> Pre-specified secondary endpoints, including time to pain progression, were evaluated in the subgroup analyses.<sup>1<\/sup>\n<\/p>\n<p>\n\u201c<!-- no quote -->These latest findings from the ARASENS trial continue to reinforce the strong efficacy and favorable safety profile of NUBEQA in mHSPC,\u201d said Maha Hussain, M.D., Genevieve Teuton Professor of Medicine in the Division of Hematology Oncology, Department of Medicine, and the Deputy Director at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine, Chicago, IL. \u201c<!-- no quote -->The growing analyses from the ARASENS trial continue to demonstrate NUBEQA\u2019s value in treating patients with mHSPC. The benefit is especially in those with high-volume or high-risk disease. They also provide treating physicians with greater insight into the mHSPC patient population that may benefit from this therapy.\u201d\n<\/p>\n<p>\n\u201c<!-- no quote -->Despite recent advances, there still remains a need for treatments that extend survival and delay disease progression. These analyses highlight the potential of NUBEQA to become a foundational therapy for mHSPC patients with various types of metastatic disease burden,\u201d said Tara Frenkl, M.D., Senior Vice President and Head of Oncology Development at Bayer. \u201c<!-- no quote -->An important part of our mission at Bayer is prostate cancer care and improving patient outcomes at different stages of the disease. We are working to ensure that as many eligible patients as possible have the opportunity to benefit from NUBEQA.\u201d\n<\/p>\n<p>\nIn the ARASENS trial, patients were randomized 1:1 to receive NUBEQA plus ADT and docetaxel versus placebo plus ADT and docetaxel. High-volume disease was defined as visceral metastases and\/or \u22654 bone metastases with \u22651 beyond the vertebral column\/pelvis, as delineated in the CHAARTED criteria. High-risk disease was defined using the LATITUDE criteria, which includes \u22652 risk factors: a Gleason score of \u22658, \u22653 bone lesions, and the presence of measurable visceral metastasis. Of 1,305 patients in the full analysis set, 1,005 (77%) had high-volume disease, 912 (70%) had high-risk disease, 300 (23%) had low-volume disease, and 393 (30%) had low-risk disease.<sup>1<\/sup>\n<\/p>\n<p>\nResults showed that NUBEQA with docetaxel prolonged OS in high-volume disease (HR=0.69; 95% CI 0.57-0.82; n=1,005). A consistent OS benefit was observed in both high-risk (HR=0.71; 95% CI 0.58-0.86; n=912) and low-risk (HR=0.62; 95% CI 0.42-0.90; n=393) disease. In the smaller group of patients with low-volume disease, the results are suggestive of a survival benefit with NUBEQA (HR=0.68; 95% CI 0.41-1.13; n=300).<sup>1<\/sup>\n<\/p>\n<p>\nIncidence of treatment-emergent adverse events (TEAEs) across subgroups were consistent with the overall ARASENS population.<sup> <\/sup>Serious adverse events in patients receiving NUBEQA compared with placebo were 45.4% versus 43.5% for those with high-volume disease, 42.9% versus 38.2% for patients with low-volume disease, 45.3% versus 42.9% for patients with high-risk disease, and 43.7% versus 40.9% for patients with low-risk disease.<sup>1<\/sup>\n<\/p>\n<p>\n<b>About the ARASENS Trial<sup>4<\/sup><\/b>\n<\/p>\n<p>\nThe ARASENS trial (NCT02799602) is the only randomized, Phase III, multi-center, double-blind, placebo-controlled trial prospectively designed to compare the use of a second-generation androgen receptor inhibitor (ARi) (NUBEQA) plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel to ADT and docetaxel (a guideline recommended treatment) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of NUBEQA twice a day or matching placebo, plus ADT and 75mg\/m<sup>2<\/sup> of docetaxel, for 6 cycles. Treatment with NUBEQA plus ADT or ADT continued until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, death, or withdrawal.\n<\/p>\n<p>\nThe primary endpoint of this trial was overall survival (OS). Time to pain progression was a secondary endpoint.\n<\/p>\n<p>\n<b>About NUBEQA<sup>\u00ae<\/sup> (darolutamide)<sup>2<\/sup><\/b>\n<\/p>\n<p>\nNUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.<sup>2<\/sup>\n<\/p>\n<p>\nOn July 30, 2019, the FDA approved NUBEQA<sup>\u00ae<\/sup> (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).\n<\/p>\n<p>\nNUBEQA is also being investigated in additional studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating NUBEQA plus ADT versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), as well as in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2F&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=www.clinicaltrials.gov.&amp;index=2&amp;md5=97036411642fe3d2deed54cac27e13fa\" rel=\"nofollow noopener\" shape=\"rect\">www.clinicaltrials.gov.<\/a>\n<\/p>\n<p>\nDeveloped jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is indicated for the treatment of adults with nmCRPC or with mHSPC in combination with docetaxel.<sup>2<\/sup> Filings in other regions are underway or planned.\n<\/p>\n<p>\n<b>INDICATIONS<\/b>\n<\/p>\n<p>\nNUBEQA<sup>\u00ae <\/sup>(darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nNon-metastatic castration-resistant prostate cancer (nmCRPC)\n<\/li>\n<li>\nMetastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel\n<\/li>\n<\/ul>\n<p>\n<b>IMPORTANT SAFETY INFORMATION<\/b>\n<\/p>\n<p>\n<b>Warnings &amp; Precautions<\/b>\n<\/p>\n<p>\n<span class=\"bwuline\">Ischemic Heart Disease<\/span> \u2013 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 2.9% 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. 0.0% 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.\n<\/p>\n<p>\n<span class=\"bwuline\">Seizure<\/span> \u2013 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 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.\n<\/p>\n<p>\n<span class=\"bwuline\">Embryo-Fetal Toxicity<\/span> \u2013 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.\n<\/p>\n<p>\n<b>Adverse Reactions<\/b>\n<\/p>\n<p>\nIn ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in \u22651% 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 (&gt;2% with a \u22652% 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 \u22652% of patients treated with NUBEQA included ischemic heart disease and heart failure.\n<\/p>\n<p>\nIn 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 \u22652% 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 (\u226510% with a \u22652% increase over placebo with docetaxel) were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (\u226530%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in &lt;10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.\n<\/p>\n<p>\n<b>Drug Interactions<\/b>\n<\/p>\n<p>\n<span class=\"bwuline\">Effect of Other Drugs on NUBEQA<\/span> \u2013 Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.\n<\/p>\n<p>\nCombined 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.\n<\/p>\n<p>\n<span class=\"bwuline\">Effects of NUBEQA on Other Drugs<\/span> \u2013 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.\n<\/p>\n<p>\nNUBEQA 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.\n<\/p>\n<p>\nReview the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.\n<\/p>\n<p>\n<b>For important risk and use information about NUBEQA, please see the accompanying full <\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Flabeling.bayerhealthcare.com%2Fhtml%2Fproducts%2Fpi%2FNubeqa_PI.pdf&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=Prescribing+Information&amp;index=3&amp;md5=ae7e465bea0e3cf51033c228c7679c97\" rel=\"nofollow noopener\" shape=\"rect\"><b>Prescribing Information<\/b><\/a><b>.<\/b>\n<\/p>\n<p>\n<b>About Metastatic Hormone-Sensitive Prostate Cancer<\/b>\n<\/p>\n<p>\nProstate 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.<sup>5<\/sup> Rates of advanced prostate cancer diagnoses have risen 4.5% annually since 2011.<sup>6<\/sup>\n<\/p>\n<p>\nAt 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.<sup>7,8<\/sup> 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.<sup>9,10<\/sup>\n<\/p>\n<p>\n<b>About Oncology at Bayer<\/b>\n<\/p>\n<p>\nBayer 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\u2019s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.\n<\/p>\n<p>\n<b>About Bayer<\/b>\n<\/p>\n<p>\nBayer 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&amp;D expenses before special items amounted to 5.3 billion euros. For more information, go to <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bayer.com&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=www.bayer.com&amp;index=4&amp;md5=31268d4f6efb3a16620f2be465b9277c\" rel=\"nofollow noopener\" shape=\"rect\">www.bayer.com<\/a>.\n<\/p>\n<p>\n<sup>\u00a9<\/sup> 2023 Bayer\n<\/p>\n<p>\nBAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.\n<\/p>\n<p>\n<b>Forward-Looking Statements<\/b>\n<\/p>\n<p>\nThis 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\u2019s public reports which are available on the Bayer website at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bayer.com&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=www.bayer.com&amp;index=5&amp;md5=701cdc962a34b0de28e2efcffc299aaa\" rel=\"nofollow noopener\" shape=\"rect\">www.bayer.com<\/a>. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.\n<\/p>\n<p>\n<b>References<\/b>\n<\/p>\n<ol class=\"bwlistdecimal\">\n<li>\nHussain, M. et al. Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase III ARASENS Trial. J Clin Oncol. 2023;41:1-13.\n<\/li>\n<li>\nNUBEQA<sup>\u00ae<\/sup> (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, August 2022.\n<\/li>\n<li>\nSmith M., Hussain M., Saad F. et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. <i>N Engl J Med.<\/i> 2022; 386:1132\u20131142.\n<\/li>\n<li>\nClinicalTrials.gov NCT02799602. ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS). <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02799602&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02799602&amp;index=6&amp;md5=a2c408c2ab02e38bf8598b8e2754a8e1\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02799602<\/a>.\n<\/li>\n<li>\nGlobal Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: <i>A Cancer Journal for Clinicians<\/i>. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Facsjournals.onlinelibrary.wiley.com%2Fdoi%2Fepdf%2F10.3322%2Fcaac.21660&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=https%3A%2F%2Facsjournals.onlinelibrary.wiley.com%2Fdoi%2Fepdf%2F10.3322%2Fcaac.21660&amp;index=7&amp;md5=ce3fbe6e05e746444cd49f6526f149c4\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/epdf\/10.3322\/caac.21660<\/a>. Accessed January 2023.\n<\/li>\n<li>\nSiegel RL, Miller KD, Wagle NS, Jemal A. (2023). Cancer Statistics, 2023. <i>CA: A Cancer Journal for Clinicians<\/i> 73(1), 17\u201348. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fdoi.org%2F10.3322%2Fcaac.21763&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=https%3A%2F%2Fdoi.org%2F10.3322%2Fcaac.21763&amp;index=8&amp;md5=bd2519a6a2c9834d24952e7418d3f8aa\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/doi.org\/10.3322\/caac.21763<\/a>.\n<\/li>\n<li>\nCancer.Net 2020: Prostate Cancer Statistics. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cancer.net%2Fcancer-types%2Fprostate-cancer%2Fstatistics&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.cancer.net%2Fcancer-types%2Fprostate-cancer%2Fstatistics&amp;index=9&amp;md5=4f1337340898ea31c4e15d9167dc4551\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.cancer.net\/cancer-types\/prostate-cancer\/statistics<\/a>. Accessed January 2023.\n<\/li>\n<li>\nAmerican Cancer Society: Hormone Therapy for Prostate Cancer. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cancer.org%2Fcancer%2Fprostate-cancer%2Ftreating%2Fhormone-therapy.html.%2520Accessed%2520January%25202023&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.cancer.org%2Fcancer%2Fprostate-cancer%2Ftreating%2Fhormone-therapy.html.+Accessed+January+2023&amp;index=10&amp;md5=647b886e33edaaa1042bcd6a39569260\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.cancer.org\/cancer\/prostate-cancer\/treating\/hormone-therapy.html. Accessed January 2023<\/a>.\n<\/li>\n<li>\nSiegel DA, O\u2019Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race\/Ethnicity \u2014 United States, 2001\u20132017. <i>MMWR Morb Mortal Wkly Rep.<\/i> 2020;69:1473\u20131480. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fdx.doi.org%2F10.15585%2Fmmwr.mm6941a1&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=http%3A%2F%2Fdx.doi.org%2F10.15585%2Fmmwr.mm6941a1&amp;index=11&amp;md5=10b016b5072665c12ae0332961951954\" rel=\"nofollow noopener\" shape=\"rect\">http:\/\/dx.doi.org\/10.15585\/mmwr.mm6941a1<\/a>.\n<\/li>\n<li>\nHahn AW, Higano CS, Taplin ME, Ryan CJ, Agarwal N. Metastatic Castration-Sensitive Prostate Cancer: Optimizing Patient Selection and Treatment. <i>Am Soc Clin Oncol Educ Book.<\/i> 2018 May 23;38:363-371. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fdoi.org%2F10.1200%2Fedbk_200967&amp;esheet=53329249&amp;newsitemid=20230216005526&amp;lan=en-US&amp;anchor=https%3A%2F%2Fdoi.org%2F10.1200%2Fedbk_200967&amp;index=12&amp;md5=14610d2fef6bac16c1a4a5217c9ce9ce\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/doi.org\/10.1200\/edbk_200967<\/a>.\n<\/li>\n<\/ol>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl bwwidth100\">\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwwidth54\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>PP-NUB-US-2190-1<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwpadl0 bwpadr0 bwvertalignb bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignr bwcellpmargin\">\n<b>2\/23<\/b>\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n\u00a0\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media:<\/b><br \/>Carolyn Nagle, Tel +1 201.419.0337<br \/>\n<br \/>Email: <a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;t&#x6f;:&#67;&#x61;&#114;&#x6f;&#108;&#x79;n&#x2e;N&#97;&#x67;&#108;&#x65;&#64;&#x62;a&#x79;&#x65;&#114;&#x2e;&#99;&#x6f;m\" rel=\"nofollow noopener\" shape=\"rect\">&#x43;&#x61;&#x72;&#111;&#108;yn&#x2e;&#x4e;&#x61;&#x67;&#108;&#101;&#64;b&#x61;&#x79;&#x65;&#114;&#46;&#99;om<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>New post hoc subgroup analyses from Phase III ARASENS trial in mHSPC show that NUBEQA plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel increased overall survival (OS) in specific subgroups with various types of metastatic disease burden and risk1 Incidence of adverse events was similar between treatment groups across all high-volume &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/new-nubeqa-darolutamide-subgroup-analyses-from-the-phase-iii-arasens-trial-in-metastatic-hormone-sensitive-prostate-cancer-mhspc-patients-presented-at-asco-gu\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-54022","format-standard","category-industry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New NUBEQA\u00ae (darolutamide) Subgroup Analyses from the Phase III ARASENS Trial in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients Presented at ASCO GU - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/new-nubeqa-darolutamide-subgroup-analyses-from-the-phase-iii-arasens-trial-in-metastatic-hormone-sensitive-prostate-cancer-mhspc-patients-presented-at-asco-gu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New NUBEQA\u00ae (darolutamide) Subgroup Analyses from the Phase III ARASENS Trial in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients Presented at ASCO GU - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"New post hoc subgroup analyses from Phase III ARASENS trial in mHSPC show that NUBEQA plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel increased overall survival (OS) in specific subgroups with various types of metastatic disease burden and risk1 Incidence of adverse events was similar between treatment groups across all high-volume ... 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