Bayer Announces Phase III ARASENS Trial Success: Nubeqa Significantly Extends Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer

News on December 20, 2021 /BioValleyBIOON/ --Bayer(Bayer) recently announced the evaluation of a new generation oral androgen receptor inhibitor (ARi)Nubeqa (Nuobeige®, generic name: darolutamide)TreatmentMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)The Phase 3 ARASENS trial met its primary endpoint.

This is a randomized, multicenter, double-blind Phase 3 trial with a prospective design aimed at evaluating the efficacy and safety of Nubeqa in combination with docetaxel and androgen deprivation therapy (ADT) for the treatment of patients with mHSPC.

The results showed,Compared with the standard care regimen of docetaxel + ADT, the Nubeqa + docetaxel + ADT regimen significantly extended overall survival (OS). In terms of safety, the overall incidence of adverse events reported across treatment groups was similar.

The detailed results of the study will be presented at the upcoming medical conference.ConferencePublished. Bayer plans to discuss the ARASENS trial data with regulatory agencies around the world and submit an application for the marketing approval of Nubeqa for the mHSPC indication.

Senior Vice President of Bayer Pharmaceuticals Division andTumorScott Z. Fields, Ph.D., Head of Development, said: "There is still a need for new treatment options to improve outcomes for patients with mHSPC. The ARASENS trial was prospectively designed to investigate whether the combination of Nubeqa with docetaxel and ADT can improve overall survival in patients with mHSPC. We are particularly grateful to the patients and investigators who participated in this important trial, and we look forward to presenting the full results at an upcoming meeting."

Globally, prostate cancer is the second most common malignant tumor in men.TumorAnd the fifth leading cause of cancer death, primarily affecting men over 50, with the risk increasing with age. In 2020, it was estimated that 1.4 million men globally wereDiagnosisAbout 375,000 men die from prostate cancer. At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate and can be treated with curative surgery or radiation therapy. When the cancer recurs, metastasizes, or spreads, Androgen Deprivation Therapy (ADT) is the cornerstone treatment for this hormone-sensitive disease.

About 5% of men at their firstDiagnosisPatients with prostate cancer accompanied by distant metastasis. Male patients with metastatic hormone-sensitive prostate cancer (mHSPC) will begin hormone therapy, such as ADT, androgen receptor inhibitor (ARi) + ADT, docetaxel + ADT, etc. Despite such treatment, most male patients with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a disease with limited survival.

Nubeqa, developed by Bayer in collaboration with the Finnish pharmaceutical company Orion, has been approved in multiple markets worldwide, including the United States and the European Union.China, Japan,For the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC)Nubeqa provides a viable option for male patients with nmCRPC.Significantly prolong metastasis-free survival (MFS) and overall survival (OS)An important treatment option with good long-term safety, helping patients to continue receiving treatment and achieving therapeutic goals.

Nubeqa is an oral next-generation non-steroidal androgen receptor (AR) inhibitor., with a unique chemical structure, binds to receptors with high affinity, demonstrating strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells. Unlike other existing nmCRPC treatments,Nubeqa does not cross the blood-brain barrier., thus potential drug interactions andFewer central nervous system side effects (such as epilepsy, falls, and cognitive impairment)。

Currently, Bayer and Orion are also developing Nubeqa for the treatment of mHSPC. In addition to the ARASENS trial, another phase 3 trial (ARANOTE) evaluating the Nubeqa+ADT regimen for mHSPC is ongoing. (Bioon.com)

Source of the original text:Phase III trial with darolutamide in combination with docetaxel and androgen deprivation therapy meets primary endpoint of significantly increasing overall survival in patients with metastatic hormone-sensitive prostate cancer