Bayer's Nubeqa (Darolutamide) Reduces Risk of Death by 31% in Men with Non-Metastatic Castration-Resistant Prostate Cancer

May 14, 2020 /BioValleyBIOON/ -- German pharmaceutical giantBayer(Bayer) recently announced the final overall survival (OS) analysis data from the pivotal Phase III ARAMIS study of Nubeqa (darolutamide), a new drug for prostate cancer. The results showed that, in men with non-metastatic castration-resistant prostate cancer (nmCRPC), Nubeqa significantly prolonged overall survival (OS) and significantly delayed the time to onset of cancer-related symptoms compared with placebo, while minimizing toxicity. These final OS analysis data will be presented at the American ClinicalTumorAmerican Society of Clinical Oncology (ASCO) 2020 Virtual ScientificConferencepublished above.

ARAMIS was a randomized, multicenter, double-blind, placebo-controlled Phase III trial that enrolled 1,509 male patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were receiving androgen deprivation therapy (ADT) and were at high risk for developing metastatic disease. The study evaluated the efficacy and safety of oral Nubeqa versus placebo. In this study, patients were randomized in a 2:1 ratio to receive either 600 mg of Nubeqa orally twice daily or placebo, while continuing ADT. Patients with a history of epilepsy were permitted to participate in the trial.

Previously reported primary efficacy endpoint data showed that, compared with placebo + ADT, the Nubeqa + ADT regimen significantly prolonged metastasis-free survival (median MFS: 40.4 months vs. 18.4 months; p < 0.0001) and significantly reduced the risk of disease metastasis or death by 59%. However, at the time of the final MFS analysis, the OS data were not yet mature.

The final overall survival (OS) analysis demonstrated that, compared with placebo plus androgen deprivation therapy (ADT), the Nubeqa plus ADT regimen significantly reduced the risk of death by 31% (HR=0.69; 95% CI: 0.53–0.88; p=0.003). It also significantly delayed time to pain progression, time to initiation of first cytotoxic chemotherapy, and time to first symptomatic skeletal event (SSE). All these secondary endpoints showed statistically significant improvements.

Nubeqa has a unique chemical structure that inhibits the growth of prostate cancer cells while limiting the burden of side effects on patients’ daily lives. With extended follow-up, Nubeqa continues to demonstrate a favorable safety profile despite prolonged treatment duration, and no new safety signals have been observed, enabling men with nmCRPC to maintain an active daily life without disruption.

Consistent with the previously reported preliminary analysis results, long-term safety analysis confirmed that the Nubeqa + ADT regimen was well tolerated compared with placebo + DT, andHypertension, There was no clinically relevant increase in the incidence of falls or central nervous system (CNS) effects.

Nubeqa is an oral non-steroidal androgen receptor (AR) inhibitor with a unique chemical structure that binds to the receptor with high affinity, exhibiting potent antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells. Unlike other existing treatments for nmCRPC, Nubeqa does not cross the blood-brain barrier, resulting in fewer potential drug interactions and central nervous system side effects (such as seizures, falls, and cognitive impairment). Currently, Nubeqa has been approved in the European Union, the United States, Australia, Brazil, Canada, and Japan, with applications in other regions either underway or planned.

Nubeqa was co-developed by Bayer and the Finnish pharmaceutical company Orion. Bayer is responsible for the global commercialization of Nubeqa, while Bayer and Orion jointly promote the drug in certain European markets, including France, Germany, Italy, Spain, the United Kingdom, Scandinavia, and Finland.

Globally, prostate cancer is the second most common malignantTumorAs the fifth leading cause of cancer-related deaths, it primarily affects men over the age of 50, with risk increasing with age. Castration-resistant prostate cancer (CRPC) refers to prostate cancer that continues to progress despite androgen deprivation therapy (ADT) reducing testosterone levels to very low levels. Approximately one-third of patients with non-metastatic CRPC (nmCRPC) develop metastases within two years; therefore, the primary treatment goals in this setting are to delay metastasis and spread of prostate cancer and to limit treatment-related side effects.

Since men with nmCRPC are typically asymptomatic and lead active lives, it is crucial to have treatment options that can delay cancer progression while minimizing treatment-related side effects, thereby enabling them to maintain their lifestyle with minimal disruption.

Nubeqa will provide an important treatment option for male patients with nmCRPC, significantly extending metastasis-free survival (MFS) and overall survival (OS). The drug demonstrates a favorable long-term safety profile, facilitating treatment continuity and the achievement of therapeutic goals.

In addition to nmCRPC, Bayer and Orion are also advancing another Phase III clinical study, ARASENS, to evaluate the efficacy and safety of darolutamide in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). (Bioon.com)

Original Source: NUBEQA (darolutamide) Plus Androgen Deprivation Therapy Showed a Statistically Significant Improvement in Overall Survival with Proven Efficacy and Tolerability in Men with Non-Metastatic Castration-Resistant Prostate Cancer