Bayer's Darolutamide (Nubeqa) Granted New Indication in China for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer

On March 16, the official website of the National Medical Products Administration (NMPA) showed that Bayer's oral androgen receptor inhibitor darolutamide (Nubeqa) has been approved for a new indication. The newly approved indication is for use in combination with docetaxel to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Darolutamide is an oral androgen receptor inhibitor (ARi) that has a high affinity for the androgen receptor and exhibits strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells. Darolutamide, jointly developed by Bayer and Orion, has been approved in more than 60 markets worldwide for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmCRPC) at high risk of metastasis.

Prostate cancer is the most common solid tumor and the second leading cause of cancer-related deaths in men in the United States. Localized prostate cancer can be treated with radical surgery or radiation therapy. When the cancer metastasizes or spreads, standard therapy for metastatic prostate cancer—Androgen Deprivation Therapy (ADT)—can be used. Additionally, treatment options such as Androgen Receptor Pathway Inhibitors + ADT or Docetaxel Chemotherapy + ADT are available. Despite receiving these therapies, the majority of patients with metastatic Hormone-Sensitive Prostate Cancer (mHSPC) will eventually progress to metastatic Castration-Resistant Prostate Cancer (mCRPC).

This approval is based on the positive results of the randomized, multicenter, double-blind, placebo-controlled Phase III ARASENS trial. ARASENS is the world's first prospectively designed triple-combination regimen for metastatic hormone-sensitive prostate cancer (mHSPC). The study enrolled 1,306 patients with newly diagnosed or recurrent mHSPC, who were randomly assigned in a 1:1 ratio to receive docetaxel + androgen deprivation therapy (ADT) + darolutamide or docetaxel + ADT + placebo, aiming to evaluate the efficacy and safety of darolutamide in treating mHSPC.

The primary endpoint of the trial was overall survival (OS), with secondary endpoints including time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), and time to first subsequent anticancer therapy. Results from the ARASENS trial demonstrated that compared to the control group, treatment with darolutamide + ADT + docetaxel significantly reduced the risk of death by 32.5%.

Notably, darolutamide is also being further studied in prostate cancer at different stages, including another Phase III trial in mHSPC (ARANOTE) and a Phase III trial (DASL-HiCaP) evaluating darolutamide as adjuvant therapy in localized prostate cancer with very high risk of recurrence.

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