Bayer Submits New Indication Application in China for Darolutamide to Treat Metastatic Hormone-Sensitive Prostate Cancer

On April 24, Bayer China announced in a press release that the supplemental new drug application for darolutamide tablets for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Darolutamide tablets are an oral androgen receptor inhibitor (ARi) that had already been approved for marketing in China. In February this year, Bayer announced positive results from the pivotal Phase 3 clinical trial of the drug in mHSPC.

Screenshot source: CDE official website

Prostate cancer is the second most common malignant tumor in men globally. Data shows that approximately 5% of men already have distant metastases at the time of initial diagnosis. Men with mHSPC will begin hormone therapy, such as androgen deprivation therapy (ADT), ARi combined with ADT, or docetaxel chemotherapy combined with ADT. Even after receiving the aforementioned first-line treatments, the majority of mHSPC patients will eventually progress to castration-resistant prostate cancer, significantly impacting survival and quality of life.

As an oral next-generation androgen receptor inhibitor, darolutamide has a unique molecular structure and high affinity for the receptor, thereby inhibiting receptor function and the growth of prostate cancer cells. Globally, darolutamide has been approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis. In China, the drug was also approved in February 2021 for the treatment of adult patients with nmCRPC (brand name: Nubeqa).

Bayer stated in the press release that the new indication registration application for darolutamide for the treatment of mHSPC was based on the pivotal Phase 3 ARASENS study. This is a randomized, Phase 3, multicenter, double-blind, placebo-controlled trial designed to prospectively investigate the safety and efficacy of darolutamide in combination with the chemotherapy drug docetaxel and ADT therapy for the treatment of patients with mHSPC. In the study, 1306 newly diagnosed patients were randomized 1:1 on top of docetaxel and standard ADT therapy to receive either darolutamide twice daily or a matching placebo. The primary endpoint of the trial was overall survival (OS).

According to the positive results of the ARASENS study previously announced by Bayer: Compared with ADT plus docetaxel, darolutamide combined with ADT plus docetaxel significantly improved OS in mHSPC patients, reducing the risk of death by 32.5%; At the data cutoff date for the primary analysis, the median treatment duration was longer in the darolutamide combined with ADT plus docetaxel group than in the ADT plus docetaxel group (16.7 months vs 41.0 months). It is reported that the results of the ARASENS study were orally presented at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) and published in The New England Journal of Medicine.

References:

[1] Bayer Nubeqa® New Indication Application for Metastatic Hormone-Sensitive Prostate Cancer Accepted by NMPA. Retrieved Apr 24, 2022. From https://mp.weixin.qq.com/s/YUuD4UM_-Y-dyet8M8aQ9Q

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