Bayer Submits New Indication Application in Japan for Nubeqa™ (Darolutamide) Combination Therapy in Metastatic Prostate Cancer

Bayer recently announced that it has submitted an additional indication application for the oral androgen receptor inhibitor (ARi) darolutamide to Japan's Ministry of Health, Labour and Welfare (MHLW). The aim is to seek approval for the use of darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) for the treatment of patients with metastatic 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 approximately 375,000 men globally died from the disease. At diagnosis, most men have localized prostate cancer, which can be treated with surgery or radiation therapy. When the disease metastasizes or spreads, it develops into metastatic prostate cancer. The growth of prostate cancer cells is androgen-dependent, so patients with metastatic prostate cancer are initially sensitive to ADT treatment, known as metastatic hormone-sensitive prostate cancer (mHSPC). Patients who experience disease progression despite continuous ADT will develop metastatic castration-resistant prostate cancer (mCRPC).

Darolutamide has a unique chemical structure that enables high-affinity binding to the androgen receptor, demonstrating strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells. The drug was previously launched under the English trade name Nubeqa and was also approved in China in February 2021, with the Chinese trade name Nuobeige, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis.

This submission is based on positive results from a pivotal Phase 3 clinical trial, which were published in The New England Journal of Medicine. In the trial, 1306 newly diagnosed patients were randomized 1:1 to receive either 600 mg of darolutamide twice daily or placebo, in addition to ADT and docetaxel. The trial results demonstrated that, among men with mHSPC, although more patients in the control group (ADT + docetaxel) later received other subsequent systemic treatments, the combination of darolutamide + ADT + docetaxel still significantly improved the overall survival rate (OS) at 4 years of treatment (62.7% vs. 50.4%).

In addition, the trial also met several secondary endpoints, including delaying the transition of patients' disease to castration-resistant prostate cancer and postponing the occurrence of pain progression. The frequency of treatment-related adverse events was similar in both groups.

▲ Overall survival data from this Phase 3 clinical trial (Image source: Reference [2])

References:

[1] Bayer submits application for additional indication of Nubeqa™ (darolutamide) in Japan. Retrieved March 11, 2022, from https://media.bayer.com/baynews/baynews.nsf/id/Bayer-submits-application-for-additional-indication-of-Nubeqa-darolutamide-in-Japan?OpenDocument&sessionID=1647104639

[2] Smith et al., (2022). Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. NEJM, DOI: 10.1056/NEJMoa2119115

(Original text has been abridged)

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