New ARASENS data reinforce strong tolerability profile of darolutamide plus ADT and docetaxel without compromising quality of life for patients with mHSPC
Not intended for U.S. and UK Media – ESMO Congress 2022
Consistent benefits were also seen in other patient-relevant endpoints, including all-cause and prostate cancer-related death and cumulative incidence of adverse events (AEs) of special interest
Berlin, September 11, 2022 – New results from the Phase III ARASENS trial evaluating quality of life (QoL) and patient-relevant endpoints for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) show that, in addition to extending overall survival (OS), darolutamide has a strong tolerability profile and ability to maintain patient QoL with control of disease-related physical symptoms and pain. The full results were presented during the ESMO Congress 2022.
“For those diagnosed with advanced prostate cancer, it is crucial to find a treatment that is not only effective but allows them to safely preserve their quality of life,” said Bertrand Tombal, M.D., Ph.D., Professor of Urology, Université catholique de Louvain (UCL), Cliniques universitaires, Saint-Luc, Brussels, Belgium. “These additional findings from the ARASENS trial further reinforce darolutamide’s potential for patients with mHSPC in this critical phase of their life.”
Additionally, treatment with darolutamide plus ADT and docetaxel showed a trend toward delaying time to worsening of disease-related physical symptoms and pain in patients with moderate or severe baseline pain and improvement across patient-relevant endpoints compared to ADT plus docetaxel, supporting early treatment intensification with addition of darolutamide. Results from the Phase III ARASENS trial have demonstrated a 32.5% reduction in risk of death and improvement across all patient-relevant endpoints for patients with early treatment intensification compared to ADT plus docetaxel.
At baseline, most patients in Phase III ARASENS trial had high QoL scores, and no pain or only mild pain (81%). Data from the study showed that darolutamide in combination with ADT and docetaxel maintained QoL with similar time to worsening (TTW) of disease-related physical symptoms and pain as ADT and docetaxel. Treatment with darolutamide in combination with ADT and docetaxel also led to fewer all-cause deaths (35.1% versus 46.8%) and prostate cancer-related deaths (26.1% versus 36.0%) compared to ADT and docetaxel.
Overall incidence of adverse events (AEs) was similar between treatment arms, despite longer treatment exposure for those treated with darolutamide (median 41.0 versus 16.7 months). Incidence of AEs of special interest was generally low and similar across both arms.
Bayer recently received U.S. Food and Drug Administration (FDA) approval for darolutamide in combination with docetaxel in mHSPC patients and has submitted applications in mHSPC to the European Medicine Agency (EMA), the Ministry of Health, Labour and Welfare (MHLW) in Japan, and China’s Center of Drug Evaluation (CDE).
Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish Pharmaceutical company.
About the ARASENS Trial1
The ARASENS trial is the only randomized, Phase III, multi-center, double-blind, trial which was prospectively designed to compare the use of a second-generation oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and chemotherapy docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in 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 darolutamide twice a day or matching placebo, plus ADT and docetaxel.
The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all evaluated at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability. Results from this trial were published in the New England Journal of Medicine.1 The ARASENS trial demonstrated that darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel.1 Improvements in the secondary endpoints supported the OS benefit observed in the trial’s primary endpoint.1
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.
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. 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 the docetaxel chemotherapy and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.
About Nubeqa™ (darolutamide)
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. This is supported by the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.
The product is approved under the brand name Nubeqa™ in more than 70 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. For the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), the product has recently been granted U.S. Food and Drug Administration (FDA) approval and is currently being reviewed by other health authorities around the globe with further filings underway. Darolutamide is also being investigated in further studies across various stages of prostate cancer, including in the Phase III ARANOTE trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC, ARASEC trial (darolutamide plus ADT) in the U.S. for mHSPC, as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov.
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 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.
Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on Twitter: @BayerPharma
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.
 Smith M., Hussain M., Saad F. et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022.
 Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians. https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21660. Accessed August 2022.
+49 30 2215 41591
+49 30 2215 41606