Nubeqa Combination Therapy Significantly Extends Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer, Meets Phase 3 Primary Endpoint

On December 3, 2021, Bayer and Orion Corporation announced that a Phase 3 clinical trial of the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) had met its primary endpoint. The trial results showed that in patients with metastatic hormone-sensitive prostate cancer (mHSPC), the addition of Nubeqa to chemotherapy drug docetaxel and standard androgen deprivation therapy (ADT) significantly extended overall survival (OS) compared to treatment with docetaxel and ADT alone. Detailed results of the trial will be presented at an upcoming scientific conference, and Bayer also plans to discuss the data with global health regulatory authorities to submit a marketing authorization application for the expanded indication of Nubeqa.

Prostate cancer is the second most common cancer in men worldwide and the fifth leading cause of cancer death in men. The growth of prostate cancer cells is androgen-dependent, so patients with metastatic prostate cancer are initially sensitive to ADT treatment (i.e., mHSPC). Recent studies have shown that the combination of androgen receptor inhibitors and ADT in the treatment of mHSPC can effectively reduce the risk of disease progression or death in patients.

Nubeqa has a unique chemical structure that can bind to the androgen receptor with high affinity and exhibits potent antagonistic activity, inhibiting the transfer of the androgen receptor into the cell nucleus and its mediated gene expression, thereby achieving the goal of suppressing the proliferation of prostate cancer cells. At the end of July 2019, the drug received approval from the U.S. FDA for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). A Phase 3 clinical trial demonstrated that Nubeqa reduced the risk of cancer metastasis or death in these patients by 59%. In February 2021, China's National Medical Products Administration (NMPA) also approved Nubeqa (Chinese trade name: Nuobeige, generic name: Darolutamide) for the treatment of adult nmCRPC patients at high risk of metastasis.

Note: The original text has been abridged.

References:

[1] Phase III Investigational Trial of Nubeqa^® (darolutamide) in Combination with Docetaxel and Androgen Deprivation Therapy (ADT) Meets Primary Endpoint of Significantly Increasing Overall Survival (OS) in Patients with mHSPC. Retrieved December 3, 2021, from https://media.bayer.de/baynews/baynews.nsf/id/Phase-III-trial-Nubeqa-darolutamide-combination-docetaxel-androgen-deprivation-therapy-meets-primary?OpenDocument&sessionID=1638556972

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