Courier Significantly Extends Lives in Selected Prostate Cancer Patients, Bayer's Innovative Combination Therapy Filed in Japan

▎WuXi AppTec content team editor Bayer recently announced that it has submitted an additional indication application for the oral androgen receptor inhibitor (ARi) darolutamide to the Japanese Ministry of Health, Labour and Welfare (MHLW), aiming to seek Approved for the treatment of patients with prostate cancer with distant metastases in combination with docetaxel and androgen deprivation therapy (ADT)
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 Prostate cancer is the second most commonly diagnosed malignancy in men worldwide
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In 2020, an estimated 1.
4 million men will be diagnosed with prostate cancer, and about 375,000 people will die from the disease globally
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At diagnosis, most men have localized prostate cancer, which can be treated with surgery or radiation
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Metastatic prostate cancer develops when the disease metastasizes or spreads
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The growth of prostate cancer cells is androgen-dependent, so patients with metastatic prostate cancer are initially sensitive to ADT treatment, namely metastatic hormone-sensitive prostate cancer (mHSPC)
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Patients with progressive disease after persistent ADT develop metastatic castration-resistant prostate cancer (mCRPC)
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Dalotamide has a unique chemical structure and can bind to androgen receptor with high affinity, showing strong antagonistic activity, thereby inhibiting receptor function and growth of prostate cancer cells
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The drug was previously marketed under the English trade name of Nubeqa and was also approved in China in February 2021 with the Chinese trade name Nubeqa for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of metastasis.
patients
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This application submission is based on positive results from a pivotal Phase 3 clinical trial and has been published in the New England Journal of Medicine
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The trial randomized 1306 newly diagnosed patients in a 1:1 ratio to receive 600 mg of dalotamide twice daily or placebo, plus ADT and docetaxel
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The results of the trial showed that in men with mHSPC, the combination of dalotamide + ADT + docetaxel showed significant improvement, although more patients in the ADT + docetaxel control group later received other subsequent systemic therapy.
The overall survival rate (OS, 62.
7% vs.
50.
4%) at 4 years of treatment was improved
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In addition, the trial met a number of secondary endpoints, including delaying the conversion of patients to castration-resistant prostate cancer and delaying the onset of pain progression
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The frequency of treatment-related adverse events was similar in the two groups
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▲ Overall survival data from this phase 3 clinical trial (Image source: Reference [2]) "Prostate cancer is the most common new cancer diagnosis in Japanese men every year
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Despite advances in treatment, most mHSPC patients will still be Disease progression within 2-3 years
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This indicates an unmet medical need for patients in early treatment that requires innovative and differentiated treatment options
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” said Ms.
Christine Roth, Member of the Executive Committee of Bayer Pharma and Head of the Oncology Strategic Business Unit, “ The submission to the MHLW for this new indication for darotamide treatment is an important step in Bayer's commitment to offer eligible patients with mHSPC a potential new treatment
that
, while having a favorable safety profile, can extend the their lives and slow disease progression
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"Reference: [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 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
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